Evaluation of a Self-Care Toolkit in Surgical Breast Cancer Patients

Sponsor

Samueli Institute for Information Biology (Other)

Overall Status

Unknown status

CT.gov ID

NCT02387320

Collaborator

San Antonio Military Medical Center (U.S. Fed), United States Department of Defense (U.S. Fed)

100

Enrollment

Locations

Arms

31.1

Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized controlled trial (RCT) in newly-diagnosed breast cancer patients seeks to determine the effectiveness of a self-care toolkit on specific symptoms associated with surgery as compared to a standard care group.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Pain Nausea Fatigue Sleep Disturbance	Other: Self-Care Toolkit	N/A

Detailed Description

The main research questions focus on whether the toolkit provides short-term benefits on symptoms associated with surgery (i.e., pain, anxiety, nausea) and whether it impacts emotional distress and other symptoms (i.e., pain, fatigue, sleep disturbance, global health, quality of life) at a two-week post-operative time point. This study will be conducted at San Antonio Military Medical Center (SAMMC) in active duty, veteran, and military dependent women newly diagnosed with breast cancer for whom surgery (e.g., lumpectomy or mastectomy) is the initial treatment option. One to two weeks prior to surgery, women diagnosed with breast cancer at SAMMC Oncology Department will be invited to participate in this study. Those who meet criteria and agree to participate will be enrolled on-study and randomly assigned to either the surgical toolkit group or standard care group. During the pre-operative period, women in the intervention group will be asked to read through the manual, listen to each of the 8 audiofiles at least once but as many times as desired, and to wear the acupressure wristbands during surgery. Women randomized to the standard care group will not receive an intervention prior to surgery but will receive the toolkit at study completion. The rationale for providing women in the standard care group with the toolkit at their post-operative visit is that the skills of breathing, meditation, and guided imagery might be potentially beneficial for them to use during their subsequent treatment or a future surgery. Additionally, qualitative interviews will be conducted in a cohort of women from the intervention group, at a two-week post-operative time point to assess their impressions and satisfaction with the toolkit; questions will focus on whether the individual used each of the toolkit's components, frequency of use, how she would rate the product's attributes (e.g., ease of use, clarity of instructions, quality rating, helpfulness), and perceptions about the helpfulness and usefulness of learned mind-body skills.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

Evaluation of a Self-Care Toolkit in Surgical Breast Cancer Patients

Study Start Date :

Jul 1, 2014

Anticipated Primary Completion Date :

Feb 1, 2017

Anticipated Study Completion Date :

Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Self-Care Toolkit Women randomized to self-care toolkit group will receive a toolkit which includes a spiral-bound instruction manual, a section of the manual that can be used as a journal, a portable mp3 player with 8 audiofile tracks with guided meditations to reduce stress and anxiety, and two acupressure wristbands to help prevent nausea.	Other: Self-Care Toolkit The self-care toolkit was designed and created for individuals undergoing surgery and/or invasive medical procedures. It provides individuals with guided instruction to learn several evidence-informed mind-body skills (e.g., breathing, relaxation, meditation, guided imagery) and tools (e.g., acupressure wristbands, journal) in order to regulate their own physiologic and emotional reactions to stressful situations and to lessen symptoms associated with surgery (principally pain, anxiety, nausea, fatigue, sleep disturbance).
No Intervention: Standard Care Women randomized to the standard care group will be informed that they will continue to receive standard of care as delivered by the SAMMC Oncology Department. The research team will inform women randomized to standard care that they will receive the self-care toolkit at their two week post-operative visit and will be able to use it subsequently if they choose to.

Arm

Intervention/Treatment

Experimental: Self-Care Toolkit

Women randomized to self-care toolkit group will receive a toolkit which includes a spiral-bound instruction manual, a section of the manual that can be used as a journal, a portable mp3 player with 8 audiofile tracks with guided meditations to reduce stress and anxiety, and two acupressure wristbands to help prevent nausea.

Other: Self-Care Toolkit

The self-care toolkit was designed and created for individuals undergoing surgery and/or invasive medical procedures. It provides individuals with guided instruction to learn several evidence-informed mind-body skills (e.g., breathing, relaxation, meditation, guided imagery) and tools (e.g., acupressure wristbands, journal) in order to regulate their own physiologic and emotional reactions to stressful situations and to lessen symptoms associated with surgery (principally pain, anxiety, nausea, fatigue, sleep disturbance).

No Intervention: Standard Care

Women randomized to the standard care group will be informed that they will continue to receive standard of care as delivered by the SAMMC Oncology Department. The research team will inform women randomized to standard care that they will receive the self-care toolkit at their two week post-operative visit and will be able to use it subsequently if they choose to.

Outcome Measures

Primary Outcome Measures

Change from preoperative in VAS General Anxiety at post-operative [Pre-operative (30 minutes to 5 hours prior to surgery) , Post-operative (within 10 hours after surgery)]
Anxiety is rated by the patient on a scale of 0 to 10, 0 being "not at all anxious" and 10 being "extremely anxious." This instrument will take up to 1 minute to complete.

Secondary Outcome Measures

Change from pre-operative DVPRS at post-operative [Pre-operative (30 minutes to 5 hours prior to surgery) , Post-operative (within 10 hours after surgery)]
The Defense and Veterans Pain Rating Scale (DVPRS) is a graphic tool to facilitate self-reported pain rating from patients. The instrument uses a scale from 0-10, 0 being "no pain" to 10 being "as bad as it could be, nothing else matters." This instrument will take up to 1 minute to complete.
Change from preoperative VAS Nausea at post- operative [Pre-operative (30 minutes to 5 hours prior to surgery) , Post-operative (within 10 hours after surgery)]
Nausea is rated by the patient on a scale of 0 to 10, 0 being "no nausea" and 10 being "extreme nausea." This instrument will take up to 1 minute to complete.
Change from baseline (PROMIS-57) Fatigue to pre-operative and follow-up 2 weeks post-operative [Baseline, Pre-operative (30 minutes to 5 hours prior to surgery), follow-up 2 weeks post-operative]
The National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) profile measure (PROMIS-57) includes eight primary domains: anxiety, pain intensity, pain interference, fatigue, sleep disturbance, depression, physical function, and satisfaction with social roles. This instrument takes approximately 25 minutes to complete.
Change from baseline (PROMIS-57) Sleep Disturbance to pre-operative and follow-up 2 weeks post-operative [Baseline, Pre-operative (30 minutes to 5 hours prior to surgery), Follow-up 2 weeks post-operative]
The National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) profile measure (PROMIS-57) includes eight primary domains: anxiety, pain intensity, pain interference, fatigue, sleep disturbance, depression, physical function, and satisfaction with social roles. This instrument takes approximately 25 minutes to complete.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

18+ years of age
Women treated at SAMMC Oncology clinic or CRDAMC Oncology clinic for newly-diagnosed breast cancer for whom surgery (e.g., lumpectomy or mastectomy) is the initial treatment option

Exclusion Criteria:

Women receiving chemotherapy, radiation or hormone therapy as first line treatment for breast cancer (i.e., any of these treatment options prior to surgery)
Severe hearing-impairment (i.e., that would interfere with ability to hear the toolkit audiofiles)