Mindfulness-Based Intervention for Latino Cancer Patients and Their Caregivers

March 10, 2026 updated by: M.D. Anderson Cancer Center

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Up to 12 weeks
Will calculate means, frequencies, and 90% confidence intervals (CIs), as applicable.
Up to 12 weeks
Attrition
Time Frame: Up to 12 weeks
Will calculate means, frequencies, and 90% CIs, as applicable.
Up to 12 weeks
Adherence
Time Frame: Up to 12 weeks
Will calculate means, frequencies, and 90% CIs, as applicable.
Up to 12 weeks
Acceptability
Time Frame: Up to 12 weeks
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
Time Frame: 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.
At 6 and 12 weeks
Quality of life questionnaire
Time Frame: 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.
At 6 and 12 weeks
Patient cancer symptoms
Time Frame: 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.
At 6 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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