Mindfulness-Based Intervention for Latino Cancer Patients and Their Caregivers

NCT04870788 | Active Not Recruiting

• 2 other identifiers: 2020-1070NCI-2021-02774
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Patient and caregiver psychological distress

  At 6 and 12 weeks

• Quality of life questionnaire

  At 6 and 12 weeks

• Patient cancer symptoms

  At 6 and 12 weeks

Study Arms (2)

Group I (mindfulness program)

EXPERIMENTAL

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.

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

Group II (mindfulness program)

EXPERIMENTAL

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.

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

Interventions

Mindfulness Relaxation BEHAVIORAL

Participate in mindfulness program

Also known as: MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction

Group I (mindfulness program); Group II (mindfulness program)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (mindfulness program); Group II (mindfulness program)

Questionnaire Administration OTHER

Ancillary studies

Group I (mindfulness program); Group II (mindfulness program)

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.

Group I (mindfulness program); Group II (mindfulness program)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Interventions

Mindfulness; Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Larkin Strong

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: May 3, 2021
• Study Start: March 24, 2021
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (1)