Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT03681405
Collaborator
National Cancer Institute (NCI) (NIH)
31
Enrollment
1
Location
2
Arms
16.1
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial studies how well two different supportive programs work in supporting optimal recovery in participants undergoing gynecological surgery. Supportive programs use different methods for helping participants cope with the surgical experience including gentle movements, counseling, writing, or relaxation techniques, and may help improve participants' well-being after gynecological surgery.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Informational Intervention
  • Other: Questionnaire Administration
  • Behavioral: Telephone-Based Intervention
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. To calculate recruitment, adherence, assessment completion, and retention rates.
SECONDARY OBJECTIVES:
  1. Document the frequency of adverse events. II. Assess descriptive data on proposed outcomes (i.e., pain, sleep disturbances, psychological distress) for the next phase of study.) III. Qualitatively assess acceptability to guide future study planning.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I (MINDFUL MOVEMENT AND BREATHING [eMMB]): Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery.

GROUP II (ATTENTION CONTROL [AC]): Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Support for Optimal Recovery Following Gynecologic Surgery Study (SOARING)
Actual Study Start Date :
Dec 7, 2018
Actual Primary Completion Date :
Apr 9, 2020
Actual Study Completion Date :
Apr 9, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Group I (eMMB)

Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery.

Other: Informational Intervention
Given information about mindful movement and breathing

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Group II (AC)

Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.

Other: Questionnaire Administration
Ancillary studies

Behavioral: Telephone-Based Intervention
Receive caring attention phone call

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants Retained in the Study [Up to 2 weeks]

    Will provide quantitative data to guide future study planning. Will calculate 95% confidence intervals for each of the feasibility measures to determine the range of estimates that are consistent with the data. Will track the number of screened participants, those who are eligible, and the percent who agree to participate. For those not meeting the eligibility criteria, reasons will be summarized. The proportion of participants and corresponding 95% CI for participants who participated in each group will be computed. Will use one-sample tests of binomial proportions to compare the recruitment, adherence, and retention rates to the hypothesized values of 50%, 70% and 70%, respectively.

  2. Percentage of Participants That Were Adhered to the Intervention [Up to 5 weeks]

    Will provide quantitative data to guide future study planning. Will calculate 95% confidence intervals for each of the feasibility measures to determine the range of estimates that are consistent with the data. Will track the number of screened participants, those who are eligible, and the percent who agree to participate. For those not meeting the eligibility criteria, reasons will be summarized. The proportion of participants and corresponding 95% CI for participants who participated in each group will be computed.

Secondary Outcome Measures

  1. Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS) [Baseline, 2 weeks and 4 weeks]

    Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. A change in pain intensity between two or more time points (baseline, 2 weeks and 4 weeks) will be reported. The PROMIS assesses pain on a numeric rating scale from 0 (no pain) to 10 (worst imaginable pain)

  2. Change in Affective Dimension of Pain [Baseline, 2 weeks and 4 weeks]

    The affective dimension of pain will be assessed with one item on a scale from 0 (not bad at all) to 10 (the most unpleasant feeling possible for me). A higher score represent a higher affective dimension of pain for the participant. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.

  3. Change in Pain Interference Per PROMIS Measure [Baseline, 2 weeks and 4 weeks]

    Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Additional analyses will include fitting mixed analysis of covariance (ANCOVA) models (adjustment for baseline) to model the trajectory of pain by time and group accounting for the repeated measures on a subject. Score range is 0-100 with a higher score representing greater pain interference for the participant. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.

  4. Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form [Baseline, 2 weeks and 4 weeks]

    Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Score range is 0-100 with higher scores representing a greater sleep disturbance for participants. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.

  5. Change in Psychological Distress Per PROMIS Depression [Baseline, 2 weeks and 4 weeks]

    Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Score range is 0-100 with the higher score representing greater depression in the participants. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.

  6. Change in Psychological Distress Per PROMIS Anxiety [Baseline, 2 weeks and 4 weeks]

    Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Score range is 0-100 with a higher score presenting a greater level of anxiety in the participants. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.

  7. Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 [Up to 4 weeks]

    Will describe any adverse events reported as frequencies.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Scheduled for an abdominal gynecological surgery (i.e. uterine, ovarian) to remove a suspected malignancy.

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1.

  • Cognitively able to complete assessments as judged by the study team.

  • Able to understand, read and write English.

Exclusion Criteria:
  • Have schizophrenia or any other psychotic disorder.

  • Have a diagnosed sleep disorder including untreated obstructive sleep apnea, periodic limb movement disorder, or restless leg syndrome.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Wake Forest University Health SciencesWinston-SalemNorth CarolinaUnited States27157

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Stephanie Sohl, Wake Forest University Health Sciences

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT03681405
Other Study ID Numbers:
  • IRB00052655
  • NCI-2018-01801
  • CCCWFU 97218
  • P30CA012197
First Posted:
Sep 24, 2018
Last Update Posted:
Nov 8, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleGroup I eHealth Mindful Movement and Breathing (eMMB)Group II Attention Control (AC)
Arm/Group DescriptionParticipants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studiesParticipants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery. Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive caring attention phone call
Period Title: Overall Study
STARTED1417
COMPLETED1317
NOT COMPLETED10

Baseline Characteristics

Arm/Group TitleGroup I (eMMB)Group II (AC)Total
Arm/Group DescriptionParticipants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studiesParticipants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery. Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive caring attention phone callTotal of all reporting groups
Overall Participants131730
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
60.6
(13.0)
58.9
(10.1)
59.7
(11.2)
Sex: Female, Male (Count of Participants)
Female
13
100%
17
100%
30
100%
Male
0
0%
0
0%
0
0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
0
0%
0
0%
Not Hispanic or Latino
13
100%
17
100%
30
100%
Unknown or Not Reported
0
0%
0
0%
0
0%
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
0
0%
1
5.9%
1
3.3%
White
13
100%
16
94.1%
29
96.7%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
0
0%
0
0%
Region of Enrollment (participants) [Number]
United States
13
100%
17
100%
30
100%

Outcome Measures

1. Primary Outcome
TitlePercentage of Participants Retained in the Study
DescriptionWill provide quantitative data to guide future study planning. Will calculate 95% confidence intervals for each of the feasibility measures to determine the range of estimates that are consistent with the data. Will track the number of screened participants, those who are eligible, and the percent who agree to participate. For those not meeting the eligibility criteria, reasons will be summarized. The proportion of participants and corresponding 95% CI for participants who participated in each group will be computed. Will use one-sample tests of binomial proportions to compare the recruitment, adherence, and retention rates to the hypothesized values of 50%, 70% and 70%, respectively.
Time FrameUp to 2 weeks

Outcome Measure Data

Analysis Population Description
Of the 14 randomized to intervention for Group I, 1 person was removed from the study following randomization (and prior to filling out any surveys at baseline) due to ineligibility. For Group I and II, not all participants completed requirements of retention to be analyzed for the study.
Arm/Group TitleGroup I (eMMB)Group II (AC)
Arm/Group DescriptionParticipants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studiesParticipants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery. Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive caring attention phone call
Measure Participants1417
Number (95% Confidence Interval) [percentage of participants retained]
78.6
604.6%
82.4
484.7%
2. Primary Outcome
TitlePercentage of Participants That Were Adhered to the Intervention
DescriptionWill provide quantitative data to guide future study planning. Will calculate 95% confidence intervals for each of the feasibility measures to determine the range of estimates that are consistent with the data. Will track the number of screened participants, those who are eligible, and the percent who agree to participate. For those not meeting the eligibility criteria, reasons will be summarized. The proportion of participants and corresponding 95% CI for participants who participated in each group will be computed.
Time FrameUp to 5 weeks

Outcome Measure Data

Analysis Population Description
Of the 14 randomized to intervention for Group I, 1 person was removed from the study following randomization (and prior to filling out any surveys at baseline) due to ineligibility. For Group I and II, not all participants completed requirements of adherence to be analyzed for the study.
Arm/Group TitleGroup I (eMMB)Group II (AC)
Arm/Group DescriptionParticipants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studiesParticipants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery. Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive caring attention phone call
Measure Participants1417
Number (95% Confidence Interval) [percentage of participants adhered]
85.7
659.2%
70.6
415.3%
3. Secondary Outcome
TitleChange in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)
DescriptionBaseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. A change in pain intensity between two or more time points (baseline, 2 weeks and 4 weeks) will be reported. The PROMIS assesses pain on a numeric rating scale from 0 (no pain) to 10 (worst imaginable pain)
Time FrameBaseline, 2 weeks and 4 weeks

Outcome Measure Data

Analysis Population Description
Investigators discovered recently that there had been a protocol deviation such that a participant had had their surgery PRIOR to filling out the baseline survey. That participant's baseline data had to be removed from our analyses and revised data has been submitted. Not all participants provided evaluable data for analysis.
Arm/Group TitleGroup I eHealth Mindful Movement and Breathing (eMMB)Group II Attention Control (AC)
Arm/Group DescriptionParticipants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studiesParticipants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery. Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive caring attention phone call
Measure Participants1117
Baseline
3.63
(3.47)
3.11
(3.41)
2 weeks change in score
-1.9
(3.57)
-0.71
(2.67)
4 weeks change in score
-2.55
(3.08)
-1.14
(3.03)
4. Secondary Outcome
TitleChange in Affective Dimension of Pain
DescriptionThe affective dimension of pain will be assessed with one item on a scale from 0 (not bad at all) to 10 (the most unpleasant feeling possible for me). A higher score represent a higher affective dimension of pain for the participant. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.
Time FrameBaseline, 2 weeks and 4 weeks

Outcome Measure Data

Analysis Population Description
Investigators discovered recently that there had been a protocol deviation such that a participant had had their surgery PRIOR to filling out the baseline survey. That participant's baseline data had to be removed from our analyses and revised data has been submitted. Not all participants provided evaluable data for analysis.
Arm/Group TitleGroup I (eMMB)Group II (AC)
Arm/Group DescriptionParticipants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studiesParticipants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery. Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive caring attention phone call
Measure Participants1117
Baseline
3.09
(3.53)
3.06
(3.75)
2 weeks change in score
-1.00
(3.89)
-0.71
(3.67)
4 weeks change in score
-2.00
(3.13)
-1.07
(2.92)
5. Secondary Outcome
TitleChange in Pain Interference Per PROMIS Measure
DescriptionBaseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Additional analyses will include fitting mixed analysis of covariance (ANCOVA) models (adjustment for baseline) to model the trajectory of pain by time and group accounting for the repeated measures on a subject. Score range is 0-100 with a higher score representing greater pain interference for the participant. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.
Time FrameBaseline, 2 weeks and 4 weeks

Outcome Measure Data

Analysis Population Description
Investigators discovered recently that there had been a protocol deviation such that a participant had had their surgery PRIOR to filling out the baseline survey. That participant's baseline data had to be removed from our analyses and revised data has been submitted. Not all participants provided evaluable data for analysis.
Arm/Group TitleGroup I (eMMB)Group II (AC)
Arm/Group DescriptionParticipants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studiesParticipants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery. Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive caring attention phone call
Measure Participants1117
Baseline
53.38
(11.22)
55.02
(10.93)
2 weeks change in score
-0.08
(13.88)
-0.93
(12.79)
4 weeks change in score
-5.92
(10.82)
-4.00
(12.27)
6. Secondary Outcome
TitleChange in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form
DescriptionBaseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Score range is 0-100 with higher scores representing a greater sleep disturbance for participants. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.
Time FrameBaseline, 2 weeks and 4 weeks

Outcome Measure Data

Analysis Population Description
Investigators discovered recently that there had been a protocol deviation such that a participant had had their surgery PRIOR to filling out the baseline survey. That participant's baseline data had to be removed from our analyses and revised data has been submitted. Not all participants provided evaluable data for analysis.
Arm/Group TitleGroup I (eMMB)Group II (AC)
Arm/Group DescriptionParticipants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studiesParticipants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery. Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive caring attention phone call
Measure Participants1117
Baseline
49.65
(11.78)
52.46
(10.33)
2 weeks change in score
-3.42
(9.03)
-2.92
(8.26)
4 weeks change in score
-1.53
(8.15)
-1.90
(7.74)
7. Secondary Outcome
TitleChange in Psychological Distress Per PROMIS Depression
DescriptionBaseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Score range is 0-100 with the higher score representing greater depression in the participants. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.
Time FrameBaseline, 2 weeks and 4 weeks

Outcome Measure Data

Analysis Population Description
Investigators discovered recently that there had been a protocol deviation such that a participant had had their surgery PRIOR to filling out the baseline survey. That participant's baseline data had to be removed from our analyses and revised data has been submitted. Not all participants provided evaluable data for analysis.
Arm/Group TitleGroup I (eMMB)Group II (AC)
Arm/Group DescriptionParticipants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studiesParticipants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery. Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive caring attention phone call
Measure Participants1117
Baseline
51.43
(11.07)
50.42
(8.51)
2 weeks score change
-7.38
(8.60)
-3.78
(9.98)
4 weeks score change
-6.58
(8.06)
-3.75
(5.47)
8. Secondary Outcome
TitleChange in Psychological Distress Per PROMIS Anxiety
DescriptionBaseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Score range is 0-100 with a higher score presenting a greater level of anxiety in the participants. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.
Time FrameBaseline, 2 weeks and 4 weeks

Outcome Measure Data

Analysis Population Description
Investigators discovered recently that there had been a protocol deviation such that a participant had had their surgery PRIOR to filling out the baseline survey. That participant's baseline data had to be removed from our analyses and revised data has been submitted. Not all participants provided evaluable data for analysis.
Arm/Group TitleGroup I (eMMB)Group II (AC)
Arm/Group DescriptionParticipants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studiesParticipants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery. Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive caring attention phone call
Measure Participants1117
Baseline
53.47
(12.29)
55.49
(8.40)
2 weeks change in score
-7.36
(7.83)
-9.66
(13.73)
4 weeks change in score
-5.86
(9.70)
-7.90
(11.64)
9. Secondary Outcome
TitleIncidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
DescriptionWill describe any adverse events reported as frequencies.
Time FrameUp to 4 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleGroup I (eMMB)Group II (AC)
Arm/Group DescriptionParticipants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studiesParticipants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery. Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive caring attention phone call
Measure Participants1114
Number [number of adverse events]
0
0

Adverse Events

Time FrameFour weeks
Adverse Event Reporting Description
Arm/Group TitleGroup I (eMMB)Group II (AC)
Arm/Group DescriptionParticipants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studiesParticipants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery. Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive caring attention phone call
All Cause Mortality
Group I (eMMB)Group II (AC)
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/13 (0%) 0/17 (0%)
Serious Adverse Events
Group I (eMMB)Group II (AC)
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/13 (0%) 0/17 (0%)
Other (Not Including Serious) Adverse Events
Group I (eMMB)Group II (AC)
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/13 (0%) 0/17 (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/TitleMeg O'Mara
OrganizationWake Forest Baptist Comprehensive Cancer Center
Phone336-716-9055
Emailmegreen@wakehealth.edu
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT03681405
Other Study ID Numbers:
  • IRB00052655
  • NCI-2018-01801
  • CCCWFU 97218
  • P30CA012197
First Posted:
Sep 24, 2018
Last Update Posted:
Nov 8, 2021
Last Verified:
Nov 1, 2021