Mindfulness-Based Intervention for Latino Cancer Patients and Their Caregivers

Not Applicable

Recruiting

• Conditions: Advanced Malignant Solid Neoplasm
• Interventions: Behavioral: Mindfulness Relaxation; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Group II (mindfulness waitlist)

• 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.

Study Timeline

• Study Start: 2021-03-24
• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-30
• Study First Posted: 2021-05-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

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Exclusion Criteria

• At least 18 years old
• Able to speak English or Spanish
• Have access to the internet
• Able to provide informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (mindfulness program)	Questionnaire Administration	Patients and their partners participate together in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks.
Group II (mindfulness program)	Mindfulness Relaxation	Patients and their partners participate separately in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks.
Group II (mindfulness program)	Group II (mindfulness waitlist)	Patients and their partners participate separately in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks.
Group II (mindfulness program)	Quality-of-Life Assessment	Patients and their partners participate separately in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks.
Group I (mindfulness program)	Group II (mindfulness waitlist)	Patients and their partners participate together in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks.
Group II (mindfulness program)	Questionnaire Administration	Patients and their partners participate separately in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks.
Group I (mindfulness program)	Mindfulness Relaxation	Patients and their partners participate together in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks.
Group I (mindfulness program)	Quality-of-Life Assessment	Patients and their partners participate together in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks.

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