| Conditions: |
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Breast Cancer |
| Purpose: |
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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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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- Participants must be a community-dwelling member 18 years of age or older. - The
participant must be at least 18 because the assessment tools are not validated for
use in minors.
- Participants should be able to read, write, and speak English.
- Participants must have been diagnosed with breast cancer and have completed surgery,
which did not include Level III dissection of the axilla.
- Participants must obtain verification of diagnosis and treatment from their
physician.
- Participants must agree to complete assessment instruments and take part in
psychophysiological data gathering at baseline, 8 and 17 weeks and to provide
required demographic information.
- Participants must sign informed consent, stating he/she understands the nature of the
research and that he/she wishes to participate in the study. -
- Participants must agree to complete the required diaries, graphs and notebooks
related to behavior assessment.
- Participants must display the ability to understand and respond to the assessment
process and must demonstrate they are oriented to person, place, and time.
- Participants must agree to fully participate in all five imagery classes and to
practice imagery skills for 20 minutes a day for 17 weeks.
- Participants must have completed major cancer treatment (i.e., surgery, and/or
radiation and/or IV chemotherapy) for six weeks; participant must be visual and
hearing capable.
- Oral chemotherapy does not preclude participation.
Exclusion Criteria:
- Participant will be excluded if he/she has a history of uncontrolled epileptic
seizures.
- The investigators will exclude patients who cannot speak, read and write English.
- Patients will be excluded if they are not oriented to place, person, and time.
- Participants will be excluded if they have a major psychiatric diagnosis
(schizophrenia, bi-polar disorder).
- The investigators will exclude patients who received a Level III dissection of the
axilla.
- Participants will be excluded if they are visually or hearing impaired.
- Although imagery can be modified for the visually or hearing impaired, that model is
significantly different from an imagery program for the visual and hearing capable.
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| NCT ID: |
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NCT01034215 |
| Primary Contact: |
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Principal Investigator
Lynda W Freeman, Ph.D.
Mind Matters Research LLC
Lynda W Freeman, Ph.D.
Phone: 907-868-7737
Email: lfreeman@gci.net
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| Backup Contact: |
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Email: ssutton@mindmattersresearch.com
Sue Sutton
Phone: 907-868-7737
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| Location Contact: |
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Seattle, Washington 98122
United States
Lynda W Freeman, Ph.D.
Phone: 907-868-7737
Email: lfreeman@gci.net
Site Status: Recruiting |