NCT04870788

Mindfulness-Based Intervention for Latino Cancer Patients and Their Caregivers

Cultural Adaptation of a Mindfulness-Based Intervention for Latino Cancer Patients and Their Caregivers

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Malignant Solid Neoplasm

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness Relaxation	Participate in mindfulness program
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Group II (mindfulness waitlist)	Patients and their partners participate in mindfulness program together or separately, depending on their preference, as in Group I beginning 12 weeks after starting the study and completing the third study visit.

Timeline

• Start date: 2021-03-24
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2021-05-03
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States