Mindfulness-Based Intervention for Latino Cancer Patients and Their Caregivers

Study Overview
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Brief Summary
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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
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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 2 groups. GROUP I: Patients and their partners participate in mindfulness program 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 as in Group I beginning 12 weeks after starting the study.

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

Conditions
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Advanced Malignant Solid Neoplasm

Intervention / Treatment
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* Behavioral: Mindfulness Relaxation
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (mindfulness program)<br>Patients and their partners participate 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. | Behavioral: Mindfulness Relaxation<br>* Participate in mindfulness program<br>* Other names: Mindfulness-Based Stress Reduction;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (mindfulness waitlist)<br>Patients and their partners participate in mindfulness program as in Group I beginning 12 weeks after starting the study | Behavioral: Mindfulness Relaxation<br>* Participate in mindfulness program<br>* Other names: Mindfulness-Based Stress Reduction;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall accrual | Will calculate means, frequencies, and 90% confidence intervals (CIs), as applicable. | Up to 12 weeks | 
| Attrition | Will calculate means, frequencies, and 90% CIs, as applicable. | Up to 12 weeks | 
| Adherence | Will calculate means, frequencies, and 90% CIs, as applicable. | Up to 12 weeks | 
| Acceptability | Will calculate means, frequencies, and 90% CIs, as applicable. | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and caregiver psychological distress | Will examine means, standard deviations (SDs), and distributions of survey measures for ceiling/floor effects and restrictions in range and examine change over time. | At 6 and 12 weeks | 
| Quality of life questionnaire | Will examine means, SDs, and distributions of survey measures for ceiling/floor effects and restrictions in range and examine change over time. | At 6 and 12 weeks | 
| Patient cancer symptoms | Will examine means, SDs, and distributions of survey measures for ceiling/floor effects and restrictions in range and examine change over time. | At 6 and 12 weeks |