Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04870788

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Advanced Malignant Solid Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Relaxation

Behavioral

Participate in mindfulness program

Other names: MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Group II (mindfulness waitlist)

Other

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.

Primary outcomes

  1. Overall accrual

    Time frame: Up to 12 weeks

    Will calculate means, frequencies, and 90% confidence intervals (CIs), as applicable.

  2. Attrition

    Time frame: Up to 12 weeks

    Will calculate means, frequencies, and 90% CIs, as applicable.

  3. Adherence

    Time frame: Up to 12 weeks

    Will calculate means, frequencies, and 90% CIs, as applicable.

  4. Acceptability

    Time frame: Up to 12 weeks

    Will calculate means, frequencies, and 90% CIs, as applicable.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
May 3, 2021
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.