Mindfulness-Based Intervention for Latino Cancer Patients and Their Caregivers

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Advanced Malignant Solid Neoplasm

Treatments: Other: Questionnaire Administration; Behavioral: Mindfulness Relaxation; Other: Group II (mindfulness waitlist); Other: Quality-of-Life Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT04870788

2020-1070 (Other Identifier)

NCI-2021-02774 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group I (mindfulness program)

Experimental group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Other: Group II (mindfulness waitlist)

Behavioral: Mindfulness Relaxation

Other: Questionnaire Administration

Group II (mindfulness program)

Experimental group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Other: Group II (mindfulness waitlist)

Behavioral: Mindfulness Relaxation

Other: Questionnaire Administration