Mindfulness-Based Intervention for Latino Cancer Patients and Their Caregivers

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Malignant Solid Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Mindfulness Relaxation; Other: Group II (mindfulness waitlist)

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 Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (mindfulness program); 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Behavioral: Mindfulness Relaxation; Participate in mindfulness program; Other Names: MBSR; Mindfulness-Based Stress Reduction; Mindfulness Meditation; Mindful Meditation; 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.
Experimental: Group II (mindfulness program); 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Behavioral: Mindfulness Relaxation; Participate in mindfulness program; Other Names: MBSR; Mindfulness-Based Stress Reduction; Mindfulness Meditation; Mindful Meditation; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Larkin Strong, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2021
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness; Mindfulness-Based Stress Reduction
• Other Study ID Numbers: 2020-1070 (Other Identifier: M D Anderson Cancer Center); NCI-2021-02774 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No