Multi-Media Imagery Program for Breast Cancer Patients (Phase II)
1 other identifier
interventional
135
1 country
1
Brief 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 outcomes than waitlist control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Aug 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 16, 2009
CompletedFirst Posted
Study publicly available on registry
December 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2011
CompletedMarch 10, 2020
December 1, 2009
2.1 years
December 16, 2009
March 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Objective: Measure QOL differences between treatment groups: (delivered live vs videoconferencing) and as compared to the control group and their extended baseline.
Data is gathered at baseline (before intervention) and 8 weeks, and at 17 weeks.
Secondary Outcomes (1)
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
Data gathered across each week, beginning with first week of intervention, for a period of 17 weeks
Study Arms (3)
Imagery Practice, live trainer
ACTIVE COMPARATORPatients 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.
"Envision the Rhythms of Life" /video
ACTIVE COMPARATORPatients 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.
Waitlist Control Group
NO INTERVENTIONNo 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)
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gilda's Club Seattle
Seattle, Washington, 98122, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lynda W Freeman, Ph.D.
Mind Matters Research LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 16, 2009
First Posted
December 17, 2009
Study Start
August 1, 2008
Primary Completion
September 1, 2010
Study Completion
October 11, 2011
Last Updated
March 10, 2020
Record last verified: 2009-12