Evaluation of a Self-Care Toolkit in Surgical Breast Cancer Patients
1 other identifier
interventional
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable anxiety
Started Jul 2014
Longer than P75 for not_applicable anxiety
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 17, 2014
CompletedFirst Posted
Study publicly available on registry
March 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedMay 12, 2016
May 1, 2016
2.6 years
November 17, 2014
May 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from preoperative in VAS General Anxiety at post-operative
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.
Pre-operative (30 minutes to 5 hours prior to surgery) , Post-operative (within 10 hours after surgery)
Secondary Outcomes (4)
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)
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)
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
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
Study Arms (2)
Self-Care Toolkit
EXPERIMENTALWomen 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.
Standard Care
NO INTERVENTIONWomen 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- + 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samueli Institute for Information Biologylead
- San Antonio Military Medical Centercollaborator
- United States Department of Defensecollaborator
Study Sites (2)
Carl R. Darnall Army Medical Center
Fort Hood, Texas, 76544, United States
San Antonio Military Medical Center
San Antonio, Texas, 78234, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kimberly McConnell, EdD
Samueli Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2014
First Posted
March 13, 2015
Study Start
July 1, 2014
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
May 12, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share