Clinical trial NCT04870788: Mindfulness-Based Intervention for Latino Cancer Patients and Their Caregivers
Official title: Cultural Adaptation of a Mindfulness-Based Intervention for Latino Cancer Patients and Their Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall accrual
timeFrame: Up to 12 weeks
measure: Attrition
timeFrame: Up to 12 weeks
measure: Adherence
timeFrame: Up to 12 weeks
measure: Acceptability
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Patient and caregiver psychological distress
timeFrame: At 6 and 12 weeks
measure: Quality of life questionnaire
timeFrame: At 6 and 12 weeks
measure: Patient cancer symptoms
timeFrame: At 6 and 12 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Larkin Strong
role: PRINCIPAL_INVESTIGATOR
References: