This clinical trial studies how well the use of internet video conference based compassion meditation intervention works to reduce psychological distress in breast cancer survivors and their caregivers. Patients with breast cancer often experience undesirable changes in quality of life related to health after they complete cancer treatments such as increased fatigue, less than ideal mood, and increased feeling of social isolation. Sometimes these changes can last for many years after the end of cancer treatments. Family members who live with breast cancer survivors such as husbands, wives, significant others, and adult children also experience similar quality of life changes. Cognitively-based compassion training (CBCT) is an 8-week meditation-based intervention for improving depression and quality of life for breast cancer survivors. CBCT is specifically oriented toward cultivation of social connections, self-compassion, and positive affect. Another wellness program, cancer health education (HE), focuses on topics relevant to health and cancer, but is also intended for individuals who are not cancer survivors themselves. This study will determine the ability of cancer HE and CBCT to improve quality of life for breast cancer survivors and their caregivers, when delivered virtually and determine if these programs have a positive impact on the stress hormone, cortisol.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05676255.
Locations matching your search criteria
United States
Arizona
Tucson
Banner University Medical Center - TucsonStatus: Active
Contact: Thaddeus Pace
Phone: 520-626-3520
PRIMARY OBJECTIVES:
I. Determine if survivors and caregivers exhibit less depression and anxiety (primary outcomes) when survivors receive online CBCT along with their informal caregiver (CBCT-dyads [D]), compared to when survivors receive online CBCT alone (CBCT-survivors [S]) or when survivors and informal caregivers receive online HE.
II. Test the extent to which reductions in survivor’s depression and anxiety from online CBCT-D are mediated by social connection, dyadic function, and caregiver distress.
III. Explore the effects of online CBCT-D versus CBCT-S and HE on survivor diurnal cortisol rhythm at months 2, 3 and 8, and the extent to which cortisol rhythm is a marker versus mediator of improvements in survivor’s distress at month 2, 3, and 8.
OUTLINE: Survivor-caregiver dyads are randomized to 1 of 3 groups.
GROUP I: Dyads complete remotely delivered cancer HE intervention over 8 weeks. Dyads complete questionnaires, participate in weekly group discussions, and receive text message reminders to complete at home assignments on study. Participants also undergo saliva sample collection on study.
GROUP II: Dyads complete remotely delivered CBCT-D intervention over 8 weeks. Dyads complete questionnaires, perform meditation, participate in weekly group discussions, and receive text message reminders to perform at home meditation on study. Participants also undergo saliva sample collection on study.
GROUP III: Survivors complete remotely delivered CBCT-S intervention over 8 weeks. Survivors complete questionnaires, perform meditation, participate in weekly group discussions, and receive text message reminders to perform at home meditation on study. Participants also undergo saliva sample collection on study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationBanner University Medical Center - Tucson
Principal InvestigatorThaddeus Pace
