Mindfulness-Based Intervention for Latino Cancer Patients and Their Caregivers
- Conditions
- Advanced Malignant Solid Neoplasm
- Registration Number
- NCT04870788
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
This clinical trial develops effective and appropriate mindfulness-based interventions that help meet the needs of Latino cancer patients and their family caregivers. Mindfulness-based interventions focus on building awareness of thoughts, emotions/feelings, and the sensations. This study may help improve mental well-being and reduce stress and anxiety associated with having cancer or with a family member's cancer diagnosis.
- Detailed Description
PRIMARY OBJECTIVES:
I. Systematically and culturally adapt a mindfulness-based intervention to improve psychological wellbeing in Latino patients with advanced cancer and their family caregivers.
II. Evaluate the feasibility of the adapted mindfulness-based intervention and overall study procedures in Latino patient-family caregiver dyads.
SECONDARY OBJECTIVE:
I. Determine the effects of the adapted mindfulness-based intervention on the secondary outcomes of patient and caregiver psychological distress, quality of life (QOL), and patient cancer symptoms, compared to a waitlist control.
OUTLINE: Patients and their partners are randomized to 1 of 32 groups.
GROUP I: Patients and their partners participate in mindfulness program together over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations 1 time per week (QW) for 4 weeks.
GROUP II: Patients and their partners participate in mindfulness program separately over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations 1 time per week (QW) for 4 weeks.
GROUP III: Patients and their partners participate in mindfulness program either separately or together, depending on participants' preferences, as in Group I beginning 12 weeks after starting the study and completing the third study visit.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Diagnosed with a stage III-IV solid tumor
- On active treatment
- Self-identify as Hispanic/Latino
- ECOG (Eastern Cooperative Oncology Group) performance status of =< 2
- Willing to participate in the study with a family caregiver (e.g., spouse, adult child) with whom they currently reside and who consents to participate
- At least 18 years old
- Able to speak English or Spanish
- Have access to the internet
- Able to provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Overall accrual Up to 12 weeks Will calculate means, frequencies, and 90% confidence intervals (CIs), as applicable.
Adherence Up to 12 weeks Will calculate means, frequencies, and 90% CIs, as applicable.
Acceptability Up to 12 weeks Will calculate means, frequencies, and 90% CIs, as applicable.
Attrition Up to 12 weeks Will calculate means, frequencies, and 90% CIs, as applicable.
- Secondary Outcome Measures
Name Time Method Patient and caregiver psychological distress At 6 and 12 weeks Will examine means, standard deviations (SDs), and distributions of survey measures for ceiling/floor effects and restrictions in range and examine change over time.
Quality of life questionnaire At 6 and 12 weeks Will examine means, SDs, and distributions of survey measures for ceiling/floor effects and restrictions in range and examine change over time.
Patient cancer symptoms At 6 and 12 weeks Will examine means, SDs, and distributions of survey measures for ceiling/floor effects and restrictions in range and examine change over time.
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States
M D Anderson Cancer Center🇺🇸Houston, Texas, United StatesLarkin StrongPrincipal Investigator