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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
68
Participate in mindfulness program
Ancillary studies
Ancillary studies
M D Anderson Cancer Center
Houston, Texas, United States
Overall accrual
Will calculate means, frequencies, and 90% confidence intervals (CIs), as applicable.
Time frame: Up to 12 weeks
Attrition
Will calculate means, frequencies, and 90% CIs, as applicable.
Time frame: Up to 12 weeks
Adherence
Will calculate means, frequencies, and 90% CIs, as applicable.
Time frame: Up to 12 weeks
Acceptability
Will calculate means, frequencies, and 90% CIs, as applicable.
Time frame: Up to 12 weeks
Patient and caregiver psychological distress
Will examine means, standard deviations (SDs), and distributions of survey measures for ceiling/floor effects and restrictions in range and examine change over time.
Time frame: At 6 and 12 weeks
Quality of life questionnaire
Will examine means, SDs, and distributions of survey measures for ceiling/floor effects and restrictions in range and examine change over time.
Time frame: At 6 and 12 weeks
Patient cancer symptoms
Will examine means, SDs, and distributions of survey measures for ceiling/floor effects and restrictions in range and examine change over time.
Time frame: At 6 and 12 weeks
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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.