Gilda's Club Seattle
Seattle, Washington, 98122, United States
NCT Number: NCT01034215
Global Objective: To improve quality of life and reduce stress for breast cancer survivors. To address the late-term and long-term effects of breast cancer treatment, as defined by the Institute of Medicine, including chemo brain, fatigue, sleep deprivation, stress, anxiety, depression, and PTSD.
Phase II Aims: (1) To demonstrate the clinical efficacy (i.e., improved quality of life, stress reduction, participant satisfaction with product) of the "Envision the Rhythms of Life" program and (2) to establish the technical merits of the program's distance-delivery (videoconferencing hardware and software) and instructional technology (i.e., animations, graphically enhanced PowerPoint instructional materials, full-color program manuals, art-as-imagery, and audio-imagery). "Envision the Rhythms of Life" instructs breast cancer survivors in the practice of individualized, emotionally supportive, and biologically accurate imagery and consists of 5, 4-hour long, interactive classes and between-class instructor support.
Instructional Options: Option 1 delivers the program technology (animations, PowerPoint, manuals, art, audio-art) with instructor and participants in the same room. Option 2 delivers the program at-a-distance, to a small group of, via videoconferencing software and camera systems (Alaska and Seattle) to low, moderate or high bandwidth areas. Each option delivers program three times (total of 45 participants for each option). A website portal provides all program information and materials.
Design and Method: Program will be delivered to 135 breast cancer survivors who have completed conventional care (surgery, radiation, IV chemotherapy) for at least six weeks. Differences in option 1 and 2 outcomes will be compared to each other and to controls; combined outcomes of option 1 and 2 will be compared to controls; and waitlist control outcomes will be compared to their extended baseline. Hypothesis: Options 1 and 2 will both produce significantly better outcomes than waitlist control group.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Seattle, Washington, 98122, United States
DESCRIPTION: To improve quality of life and reduce stress for breast cancer survivors. Phase II Aims: (1) To demonstrate the clinical efficacy (i.e., improved quality of life, stress reduction, participant satisfaction with product) of the "Envision the Rhythms of Life" program and (2) to establish the technical merits of the program's distance-delivery (videoconferencing hardware and software) and instructional technology (i.e., animations, graphically enhanced PowerPoint instructional materials, full-color program manuals, art-as-imagery, and audio-imagery). "Envision the Rhythms of Life" instructs breast cancer survivors in the practice of individualized, emotionally supportive, and biologically accurate imagery and consists of 5, 3-hour long, interactive classes and between-class instructor support. Instructional Options: Option 1 delivers the program technology (animations, PowerPoint, manuals, art, audio-art) with instructor and 15 participants in the same room. Option 2 delivers the program at-a-distance, to a small group of 15, via videoconferencing software and camera systems (Alaska and Seattle) to low, moderate or high bandwidth areas. Each option delivers program three times (total of 45 participants for each option). A website portal provides all program information and materials. Design and Method: Program will be delivered to 135 breast cancer survivors who have completed conventional care (surgery, radiation, IV chemotherapy) for at least six weeks. Differences in option 1 and 2 outcomes will be compared to each other and to controls; combined outcomes of option 1 and 2 will be compared to controls; and waitlist control outcomes will be compared to their extended baseline. Long-Term Objectives: This innovative project integrates technology with bandwidth-sensitive multi-media conferencing strategies to deliver a virtual mind-body, imagery intervention. The technology will allow seamless program delivery to interested survivors across the country during Phase III. Instructional technology, designed per Phase I participant feedback, will serve to 'jump-start' potent imagery practice and will optimize clinical efficacy. Commercial application and survivor participation is not limited by location, work schedule, or health status, addressing issues of barriers to access of care. Although desirable, instructional options 1 and 2 do not require survivors to have computer skills or internet access. The program is designed to be culturally sensitive and supports individual spiritual practices. PUBLIC HEALTH RELEVANCE: This program addresses NCI and IOM summary reports that call for individualized supportive care for cancer survivors suffering disease-related distress. Changes in two disease-education program modules would allow the program to be used as supportive therapy for other forms of cancer across the country.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients learn to practice passive, active and targeted imagery for the purpose of improving mood state, modifying physiology (HRV, Body temperature, pain reduction) and also to mitigate the effects of their treatments, as defined by the IOM: chemo brain, fatigue, sleep deprivation, stress, anxiety, depression, and/or PTSD. Program is delivered with trainer present in the room.
Other names: Envision the Rhythms of Life, Live delivery
Patients learn to practice passive, active and targeted imagery for the purpose of improving mood state, modifying physiology (HRV, Body temperature, pain reduction) and also to mitigate the effects of their treatments, as defined by the IOM: chemo brain, fatigue, sleep deprivation, stress, anxiety, depression, and/or PTSD. Program is delivered by videoconference equipment
Other names: Envision the Rhythms of Life Program, Distance Delivery
Time frame: Data is gathered at baseline (before intervention) and 8 weeks, and at 17 weeks.
Time frame: Data gathered across each week, beginning with first week of intervention, for a period of 17 weeks
Mind Matters Research LLC
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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