Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT03032250
Collaborator
National Cancer Institute (NCI) (NIH)
35
1
2
34.9
1

Study Details

Study Description

Brief Summary

This pilot clinical trial studies how well Prepare to Care kit works in improving caregiver support in patients with stage I-IV head and neck cancer that is new or has come back. Prepare to Care kit may increase knowledge about head and neck cancer and enhance stress-management skills.

Condition or Disease Intervention/Treatment Phase
  • Other: Communication Intervention
  • Other: Watch video
  • Other: Module completion of the Prepare to Care kit
  • Other: Quality-of-Life Assessment
  • Other: Survey Administration
  • Other: Salivary cortisol collection
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. To assess feasibility (accrual, participation, and retention) and acceptability of a supported self-management intervention for psycho-education and stress management skills building designed for informal caregivers (intervention group n=20; waitlist control group, n=20) of head and neck cancer (HNC) patients undergoing radiotherapy (RT).

  2. To obtain preliminary data on caregiver intermediate (self-efficacy for [a] coping with cancer and [b] abbreviated progressive muscle relaxation) and outcome variables (burden, psychological distress, quality of life) in intervention caregivers and waitlist control caregivers at the start of radiation (T1), end of radiation (T2), and 6-weeks post-radiation (T3).

  3. To compare intermediate (self-efficacy for (a) coping with cancer and (b) abbreviated progressive muscle relaxation) and outcome variables (burden, psychological distress, quality of life) between intervention caregivers and waitlist control caregivers at T1, T2, and T3.

  4. To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Caregivers watch introduction video on a digital video disc (DVD) over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.

GROUP II: Caregivers receive educational intervention as in Group I but do not attend interventionist sessions.

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer Caregivers
Actual Study Start Date :
May 15, 2017
Actual Primary Completion Date :
Apr 10, 2020
Actual Study Completion Date :
Apr 10, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group I Supportive Care (Prepare to Care kit)

Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.

Other: Communication Intervention
Attend interventionist sessions

Other: Watch video
Watch video on a DVD
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
  • Other: Module completion of the Prepare to Care kit
    Complete modules of the Prepare to Care kit
    Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Survey Administration
    Ancillary studies

    Other: Salivary cortisol collection
    Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.

    Experimental: Group II Control Group

    Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study

    Other: Watch video
    Watch video on a DVD
    Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
  • Other: Module completion of the Prepare to Care kit
    Complete modules of the Prepare to Care kit
    Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Survey Administration
    Ancillary studies

    Other: Salivary cortisol collection
    Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions [Six weeks post radiation therapy]

      10-item quantitative survey will be developed for study to assess how much caregivers liked different aspects of the intervention. Acceptability will be summarized quantitatively and qualitatively. These acceptability questions were asked only of caregivers in the intervention group - Group 1 Supportive Care (Prepare to Care Kit). All data is based on participants answering the acceptability questions as "Quite a Bit/Very Much Helpful" for the intervention materials. Not all participants answered this part of the outcome measure.

    2. Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment [Up to 1 year]

      38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month

    3. Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) [Baseline and following radiotherapy, assessed up to 1 year]

      21-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). The CRA has been tested in cancer caregivers; demonstrated validity and reliability. Minimum and maximum scoring scale: BASELINE: Scores for esteem 15-31; lack of family support 5-15, impact of finances 3-12, impact of schedule 12-23, impact of health 11-16). AFTER RADIOTHERAPY: Scores for esteem 20-31; lack of family support 9-17, impact of finances 7-11, impact of schedule 14-22, impact of health 12-17). The higher the score the more the item being assessed impacted the participant.

    4. Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD) [Before and after radiotherapy, assessed up to 1 year]

      The score is the sum of the 20 questions. Possible scoring range is 0-60. A score of 16 points or more is considered depressed.

    5. Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc) [Before and after radiotherapy, assessed up to 1 year]

      35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). The Cqol-Canc has demonstrated validity and reliability. Minimum and maximum score at baseline is a range of 9-78 and after radiotherapy a range of 2-73. The higher the score the greater the level of change in the quality of life for participants.

    6. Frequency of Intervention Modules Utilized Assessed by Caregiver Logs [Up to 1 year]

      Data on intervention resources used and time spent using them based on caregivers in intervention group

    7. Number of Participants in Agreement to Perform Interventions [Up to 1 year]

      Participation assessed by number of eligible participants who agreed to participate and complete study interventions.

    8. Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate [Up to 1 year]

    9. Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR) [At baseline and up to the end of radiotherapy, assessed up to 1 year]

      A 3-item instrument developed for study to evaluate self-efficacy in APMR. Minimum to maximum scores range from 3-27. Higher scores demonstrate higher self efficacy in participants.

    10. Self-efficacy in Coping With Cancer Caregiver Inventory [At baseline and up to the end of radiotherapy, assessed up to 1 year]

      21-item instrument assessing caregivers' perceived self-efficacy for coping with cancer (managing medical information, caring for care recipient, caring for oneself, managing difficult interactions/emotions); demonstrated validity and reliability. Minimum and maximum scores range from 10-63. Higher scores indicate higher self-efficacy in coping with cancer from the participants.

    11. Salivary Cortisol Collection [Up to 1 year]

      For eligible caregivers only - collected three times a day (at awakening, 30 minutes post-awakening, and bedtime) for two consecutive days following T1 (start of radiation), T2 (end of radiation), and T3 (6 weeks post radiation). To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening response, area under the curve, and intra-individual cortisol variability). Investigators will use a mixed model to evaluate differences between the groups in these parameters at times T1 and T2 and T3

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    CAREGIVERS:
    • Providing the majority of the informal (unpaid) care during radiation therapy for a patient meeting inclusion criteria and participating in study
    CARE-RECIPIENTS:
    • Has a new or recurrent American Joint Committee on Cancer (AJCC) stage I-IV squamous cell carcinoma of the upper aerodigestive tract (including lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, and larynx cancers)

    • Has planned external beam radiotherapy (+/- chemotherapy) for 6-7 weeks

    • Has an informal (unpaid) caregiver during radiation therapy who is participating in study

    Exclusion Criteria:
    • CAREGIVERS: Has a current cancer diagnosis

    • CAREGIVERS: Cannot read/communicate in English

    • CAREGIVERS: Have an endocrine disorder (e.g., diabetes and thyroid disorders), or is currently taking a steroid based medication will not be eligible to participate in the saliva portion of the study

    • CARE-RECIPIENTS: Cannot read/communicate in English

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Comprehensive Cancer Center of Wake Forest University Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • Wake Forest University Health Sciences
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Chandylen Nightingale, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT03032250
    Other Study ID Numbers:
    • IRB00038084
    • NCI-2016-02045
    • CCCWFU 99616
    • P30CA012197
    • R03CA208560
    First Posted:
    Jan 26, 2017
    Last Update Posted:
    Jan 31, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Group I Supportive Care (Prepare to Care Kit) Group II Control Group
    Arm/Group Description Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study. Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    Period Title: Overall Study
    STARTED 17 18
    COMPLETED 17 18
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Group I Supportive Care (Prepare to Care Kit) Group II Control Group Total
    Arm/Group Description Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study." Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. Total of all reporting groups
    Overall Participants 17 18 35
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    55.3
    (15.5)
    57.4
    (11.8)
    56.4
    (13.6)
    Sex: Female, Male (Count of Participants)
    Female
    17
    100%
    4
    22.2%
    21
    60%
    Male
    0
    0%
    14
    77.8%
    14
    40%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    Not Hispanic or Latino
    16
    94.1%
    18
    100%
    34
    97.1%
    Unknown or Not Reported
    1
    5.9%
    0
    0%
    1
    2.9%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    1
    5.9%
    4
    22.2%
    5
    14.3%
    White
    16
    94.1%
    13
    72.2%
    29
    82.9%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    1
    5.6%
    1
    2.9%
    Region of Enrollment (participants) [Number]
    United States
    17
    100%
    18
    100%
    35
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
    Description 10-item quantitative survey will be developed for study to assess how much caregivers liked different aspects of the intervention. Acceptability will be summarized quantitatively and qualitatively. These acceptability questions were asked only of caregivers in the intervention group - Group 1 Supportive Care (Prepare to Care Kit). All data is based on participants answering the acceptability questions as "Quite a Bit/Very Much Helpful" for the intervention materials. Not all participants answered this part of the outcome measure.
    Time Frame Six weeks post radiation therapy

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group I Supportive Care (Prepare to Care Kit)
    Arm/Group Description Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    Measure Participants 17
    Introductory DVD
    4
    23.5%
    Meetings with study interventionist
    6
    35.3%
    Relaxation CD
    7
    41.2%
    Weekly text reminders
    6
    35.3%
    Weekly email reminders
    4
    23.5%
    Study website
    0
    0%
    Clinic iPads
    0
    0%
    Cancer Education workbook
    9
    52.9%
    Utilizing Resources workbook
    7
    41.2%
    Managing Time workbook
    7
    41.2%
    Seeking/Accepting Support workbook
    7
    41.2%
    Communicating with Others workbook
    7
    41.2%
    Healthy Behaviors workbook
    7
    41.2%
    Positive Coping workbook
    7
    41.2%
    Muscle Relaxation workbook
    7
    41.2%
    2. Primary Outcome
    Title Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment
    Description 38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month
    Time Frame Up to 1 year

    Outcome Measure Data

    Analysis Population Description
    38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month
    Arm/Group Title All Participants
    Arm/Group Description Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    Measure Participants 38
    Number [participants/months]
    1.7
    10%
    3. Primary Outcome
    Title Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)
    Description 21-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). The CRA has been tested in cancer caregivers; demonstrated validity and reliability. Minimum and maximum scoring scale: BASELINE: Scores for esteem 15-31; lack of family support 5-15, impact of finances 3-12, impact of schedule 12-23, impact of health 11-16). AFTER RADIOTHERAPY: Scores for esteem 20-31; lack of family support 9-17, impact of finances 7-11, impact of schedule 14-22, impact of health 12-17). The higher the score the more the item being assessed impacted the participant.
    Time Frame Baseline and following radiotherapy, assessed up to 1 year

    Outcome Measure Data

    Analysis Population Description
    Not all participants submitted information after completion of radiotherapy.
    Arm/Group Title Group I Supportive Care (Prepare to Care Kit) Group II No Interventionist Sessions
    Arm/Group Description Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. Caregivers receive educational intervention as in Group I but do not attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    Measure Participants 17 18
    Esteem at baseline
    25.98
    (3.6)
    25.88
    (3.8)
    Lack of family support at baseline
    11.29
    (2.69)
    11.25
    (2.67)
    Impact on finances at baseline
    8.29
    (2.28)
    8.89
    (1.78)
    Impact on schedule at baseline
    17.35
    (3.31)
    16.78
    (4.1)
    Impact on health at baseline
    13.94
    (1.48)
    13.67
    (1.65)
    Esteem after radiotherapy
    25.75
    (3.31)
    25.30
    (4.19)
    Lack of family support after radiotherapy
    12.58
    (2.23)
    11.19
    (3.23)
    Impact on finances after radiotherapy
    8.42
    (1.16)
    8.25
    (1.24)
    Impact on schedule after radiotherapy
    18.33
    (2.74)
    16.56
    (4.43)
    Impact on health after radiotherapy
    14.33
    (1.61)
    14.38
    (1.59)
    4. Primary Outcome
    Title Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD)
    Description The score is the sum of the 20 questions. Possible scoring range is 0-60. A score of 16 points or more is considered depressed.
    Time Frame Before and after radiotherapy, assessed up to 1 year

    Outcome Measure Data

    Analysis Population Description
    Not all participants completed this intervention after radiotherapy timeframe indicated for this outcome measure
    Arm/Group Title Group I Supportive Care (Prepare to Care Kit) Group II No Interventionist Sessions
    Arm/Group Description Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. Caregivers receive educational intervention as in Group I but do not attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    Measure Participants 17 18
    Score at baseline
    19.71
    (13.05)
    19.28
    (12.97)
    Score after radiotherapy
    19.00
    (15.66)
    13.58
    (8.65)
    5. Primary Outcome
    Title Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)
    Description 35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). The Cqol-Canc has demonstrated validity and reliability. Minimum and maximum score at baseline is a range of 9-78 and after radiotherapy a range of 2-73. The higher the score the greater the level of change in the quality of life for participants.
    Time Frame Before and after radiotherapy, assessed up to 1 year

    Outcome Measure Data

    Analysis Population Description
    Not all participants completed this intervention after radiotherapy as indicated for this outcome measure.
    Arm/Group Title Group I Supportive Care (Prepare to Care Kit) Group II No Interventionist Sessions
    Arm/Group Description Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. Caregivers receive educational intervention as in Group I but do not attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    Measure Participants 17 17
    At baseline
    87.63
    (25.95)
    87.26
    (20.32)
    After radiotherapy
    92.55
    (22.09)
    89.86
    (18.78)
    6. Primary Outcome
    Title Frequency of Intervention Modules Utilized Assessed by Caregiver Logs
    Description Data on intervention resources used and time spent using them based on caregivers in intervention group
    Time Frame Up to 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group I Supportive Care (Prepare to Care Kit)
    Arm/Group Description Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    Measure Participants 17
    Cancer Education
    22.3
    (10.2)
    Utilizing Resources
    38.7
    (20.1)
    Seeking/ Accepting Support
    55.2
    (27.8)
    Communicating with others
    40.3
    (12.7)
    Managing Time
    40.8
    (26.9)
    Coping
    66.7
    (51.1)
    Practicing Healthy Behaviors
    48
    (15.6)
    Relaxation CD
    58
    (18.1)
    7. Primary Outcome
    Title Number of Participants in Agreement to Perform Interventions
    Description Participation assessed by number of eligible participants who agreed to participate and complete study interventions.
    Time Frame Up to 1 year

    Outcome Measure Data

    Analysis Population Description
    90 eligible patient/caregiver dyads, 38 agreed to participate
    Arm/Group Title Combination of Intervention and Control Groups to Assess Participation
    Arm/Group Description Participation assessed by proportion of eligible participants who agreed to participate
    Measure Participants 90
    Count of Participants [Participants]
    38
    223.5%
    8. Primary Outcome
    Title Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate
    Description
    Time Frame Up to 1 year

    Outcome Measure Data

    Analysis Population Description
    38 agreed to participate (19 in caregiver intervention group, 19 in caregiver control group)
    Arm/Group Title Group I Supportive Care (Prepare to Care Kit) Group II No Interventionist Sessions
    Arm/Group Description Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. Caregivers receive educational intervention as in Group I but do not attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    Measure Participants 38 38
    Count of Participants [Participants]
    12
    70.6%
    16
    88.9%
    9. Primary Outcome
    Title Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR)
    Description A 3-item instrument developed for study to evaluate self-efficacy in APMR. Minimum to maximum scores range from 3-27. Higher scores demonstrate higher self efficacy in participants.
    Time Frame At baseline and up to the end of radiotherapy, assessed up to 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group I Supportive Care (Prepare to Care Kit) Group II No Interventionist Sessions
    Arm/Group Description Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. Caregivers receive educational intervention as in Group I but do not attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    Measure Participants 17 18
    At baseline
    11.88
    (6.53)
    13.33
    (5.36)
    After radiotherapy
    16.08
    (2.68)
    12.19
    (5.59)
    10. Primary Outcome
    Title Self-efficacy in Coping With Cancer Caregiver Inventory
    Description 21-item instrument assessing caregivers' perceived self-efficacy for coping with cancer (managing medical information, caring for care recipient, caring for oneself, managing difficult interactions/emotions); demonstrated validity and reliability. Minimum and maximum scores range from 10-63. Higher scores indicate higher self-efficacy in coping with cancer from the participants.
    Time Frame At baseline and up to the end of radiotherapy, assessed up to 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group I Supportive Care (Prepare to Care Kit) Group II No Interventionist Sessions
    Arm/Group Description Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. Caregivers receive educational intervention as in Group I but do not attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    Measure Participants 17 18
    Managing medical information at baseline
    22.35
    (3.26)
    22.00
    (3.29)
    Caring for care recipient at baseline
    52.94
    (9.65)
    55.11
    (6.11)
    Caring for oneself at baseline
    25.71
    (10.44)
    28.06
    (7.83)
    Managing difficult interactions/emotions at baseline
    34.52
    (10.96)
    39.13
    (7.95)
    Managing medical information after radiotherapy
    23.08
    (2.54)
    22.43
    (4.80)
    Caring for care recipient after radiotherapy
    54.42
    (5.62)
    54.98
    (6.82)
    Caring for oneself after radiotherapy
    25.75
    (9.40)
    31.30
    (8.26)
    Managing difficult interactions/emotions after radiotherapy
    37.92
    (10.03)
    39.68
    (7.86)
    11. Primary Outcome
    Title Salivary Cortisol Collection
    Description For eligible caregivers only - collected three times a day (at awakening, 30 minutes post-awakening, and bedtime) for two consecutive days following T1 (start of radiation), T2 (end of radiation), and T3 (6 weeks post radiation). To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening response, area under the curve, and intra-individual cortisol variability). Investigators will use a mixed model to evaluate differences between the groups in these parameters at times T1 and T2 and T3
    Time Frame Up to 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time Frame 6 weeks
    Adverse Event Reporting Description
    Arm/Group Title Group I Supportive Care (Prepare to Care Kit) Group II Control Group
    Arm/Group Description Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study. Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
    All Cause Mortality
    Group I Supportive Care (Prepare to Care Kit) Group II Control Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/17 (0%) 0/18 (0%)
    Serious Adverse Events
    Group I Supportive Care (Prepare to Care Kit) Group II Control Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/17 (0%) 0/18 (0%)
    Other (Not Including Serious) Adverse Events
    Group I Supportive Care (Prepare to Care Kit) Group II Control Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/17 (0%) 0/18 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Principal Investigator
    Organization Wake Forest Baptist Comprehensive Cancer Center
    Phone 336-713-1432
    Email cnightin@wakehealth.edu
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT03032250
    Other Study ID Numbers:
    • IRB00038084
    • NCI-2016-02045
    • CCCWFU 99616
    • P30CA012197
    • R03CA208560
    First Posted:
    Jan 26, 2017
    Last Update Posted:
    Jan 31, 2022
    Last Verified:
    Jan 1, 2022