This clinical trial studies how well a family-focused meditation (FFM) program works in patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and their family caregivers psychological wellbeing and overall quality of life. Patients with metastatic cancer have limited life expectancy and high symptom burden including psychological and spiritual distress. Living longer with metastatic cancer often comes with burdensome physical and psychosocial symptoms that increase the need for support and care from the family. Patients with metastatic cancer and their families often struggle with the uncertain prognosis and fear of disease progression. This patient-caregiver population is at high risk for experiencing psychological and spiritual/existential distress (e.g., lack of meaning and peace, despair, alienation). The FFM program integrates meditation-based techniques cultivating positive affect with emotional disclosure exercises to reinforce positive emotions and foster emotional closeness within the patient-caregiver dyads. This study will determine the ability of the FFM program to improve the wellbeing and overall quality of life in patients with metastatic cancer and their caregivers.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06409065.
Locations matching your search criteria
United States
Texas
Houston
Memorial Hermann Texas Medical CenterStatus: Approved
Contact: Julie Haewon Rowe
M D Anderson Cancer CenterStatus: Active
Contact: Kathrin Milbury
Phone: 713-745-2868
PRIMARY OBJECTIVES:
I. Compare the extent to which the FFM program improves patient and caregiver depressive symptoms (primary outcome) and spiritual wellbeing (secondary outcome) relative to the attention control (AC) and usual care (UC) control groups.
II. Establish that the FFM program improves negative and positive affect and emotional closeness as assessed by self-report and observational (i.e., the electronically activated recorder [EAR]) data relative to the AC and UC groups, which in turn improve primary and secondary outcomes.
III. Explore patient and caregiver psychospiritual adjustment and experiences with the transition to end of life (EOL) care and caregiver bereavement adjustment to inform future intervention research using a convergent parallel mixed-methods approach.
OUTLINE: Patient-caregiver dyads are randomized to 1 of 3 arms.
ARM I: Dyads participate in remotely delivered FFM program consisting of sessions with a trained counselor focusing on intrapersonal (i.e., meditations) and interpersonal (i.e., emotional sharing) exercises to foster positive affect and emotional closeness over 60 minutes once a week (QW) for 4 weeks.
ARM II: Dyads participate in remotely delivered family-focused cancer-related discussion program (AC program) consisting of sessions with a trained counselor focusing on discussing cancer-related and non-cancer related concerns that families tend to experience when coping with cancer over 60 minutes QW for 4 weeks.
ARM III: Dyads receive usual care for 4 weeks.
After completion of study intervention, dyads are followed up at weeks 8, 12 and 24 as well as at EOL care transition. Caregivers may optionally be followed up at 3 - 5 months after patient death if there was no transition to EOL care before patient death.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorKathrin Milbury
