Mindfulness-Based Intervention for Latino Cancer Patients and Their Caregivers

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status

Enrolling

Conditions

Advanced Malignant Solid Neoplasm

Treatments

Other: Questionnaire Administration
Behavioral: Mindfulness Relaxation
Other: Quality-of-Life Assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT04870788
2020-1070 (Other Identifier)
NCI-2021-02774 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Group I (mindfulness program)
Experimental group
Description:
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.
Treatment:
Other: Quality-of-Life Assessment
Behavioral: Mindfulness Relaxation
Other: Questionnaire Administration
Group II (mindfulness waitlist)
Active Comparator group
Description:
Patients and their partners participate in mindfulness program as in Group I beginning 12 weeks after starting the study
Treatment:
Other: Quality-of-Life Assessment
Behavioral: Mindfulness Relaxation
Other: Questionnaire Administration

Trial contacts and locations

0

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Central trial contact

Larkin Strong

Data sourced from clinicaltrials.gov

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