Multi-Media Imagery Program for Breast Cancer Patients (Phase II)
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|ClinicalTrials.gov Identifier: NCT01034215|
Recruitment Status : Unknown
Verified December 2009 by Mind Matters Research LLC.
Recruitment status was: Recruiting
First Posted : December 17, 2009
Last Update Posted : December 17, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Envision the Rhythms of Life Program Behavioral: Envision the Rhythms of Life Program/Distance||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||135 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Multi-Media Imagery Program for Breast Cancer Patients (Phase II)|
|Study Start Date :||August 2008|
|Estimated Primary Completion Date :||September 2010|
|Estimated Study Completion Date :||October 2010|
Active Comparator: Imagery Practice, live trainer
Patients attend a five week training program, with the instructor in the room with them, and actively practice imagery techniques, both in the classroom, and daily, outside of the classroom. Classes are four hours a week for five weeks. Patients practice what they learn for a full 17 weeks, beginning with the first week of class.
Behavioral: Envision the Rhythms of Life Program
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 Name: Envision the Rhythms of Life, Live delivery
Active Comparator: "Envision the Rhythms of Life" /video
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.
Behavioral: Envision the Rhythms of Life Program/Distance
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 Name: Envision the Rhythms of Life Program, Distance Delivery
No Intervention: Waitlist Control Group
No treatment delivery during the 17 weeks of testing live delivery (trainer in the room with patients) vs. distance delivery (trainer delivers program via telemedicine/videoconferencing equipment)
- Primary Objective: Measure QOL differences between treatment groups: (delivered live vs videoconferencing) and as compared to the control group and their extended baseline. [ Time Frame: Data is gathered at baseline (before intervention) and 8 weeks, and at 17 weeks. ]
- The secondary objective is for the purposes of improving program materials, documenting patient satisfaction, and recording patient experience of imagery. Focus groups, summary reports, and 10-point likert scales, rated from very dissatisfied (1) to very [ Time Frame: Data gathered across each week, beginning with first week of intervention, for a period of 17 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034215
|Contact: Lynda W Freeman, Ph.D.||email@example.com|
|Contact: Sue Suttonfirstname.lastname@example.org|
|United States, Washington|
|Gilda's Club Seattle||Recruiting|
|Seattle, Washington, United States, 98122|
|Contact: Lynda W Freeman, Ph.D. 907-868-7737 email@example.com|
|Principal Investigator: Lynda W Freeman, Ph.D.|
|Principal Investigator:||Lynda W Freeman, Ph.D.||Mind Matters Research LLC|