Multi-Media Imagery Program for Breast Cancer Patients (Phase II)

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01034215

Run by

Mind Matters Research LLC

People needed

135

Starts

2008-08-01

Expected to finish

2011-10-11

Last updated by the study team

2020-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Gilda's Club Seattle — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.