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NCT01034215 · ClinicalTrials.gov registry record · Phase 2
Multi-Media Imagery Program for Breast Cancer Patients (Phase II)
A Phase 2 study of Breast Cancer, sponsored by Mind Matters Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 135
- Enrollment target
- 1
- Study location
NCT01034215: Completed Phase 2 study of Breast Cancer, sponsored by Mind Matters Research.
NCT01034215 is a Phase 2 study of Breast Cancer that has completed, run by Mind Matters Research. The registered enrollment target is 135 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01034215, a Phase 2 study of Breast Cancer, has completed, sponsored by Mind Matters Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 135 participants
- Enrollment target
- 1
- Study location
Study Summary
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 outcome
Conditions Studied
Interventions
- BEHAVIORAL Envision the Rhythms of Life Program
- BEHAVIORAL Envision the Rhythms of Life Program/Distance
Study Locations (1)
Washington
- Gilda's Club Seattle - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2008-08 |
| Est. Completion | 2011-10-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01034215
The ClinicalTrials.gov registry entry for NCT01034215 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The listed sponsor is Mind Matters Research, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Envision the Rhythms of Life Program is the first listed.
NCT01034215 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT01034215 about?
NCT01034215 is a clinical study titled "Multi-Media Imagery Program for Breast Cancer Patients (Phase II)". 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. P...
What is the current status of trial NCT01034215?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 135 participants. The study started on 2008-08. Estimated completion is 2011-10-11.
What conditions does trial NCT01034215 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT01034215?
The interventions under investigation include: Envision the Rhythms of Life Program (BEHAVIORAL), Envision the Rhythms of Life Program/Distance (BEHAVIORAL).
Who is sponsoring clinical trial NCT01034215?
This trial is sponsored by Mind Matters Research, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01034215 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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