Advanced Malignant Solid Neoplasm
Conditions
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.
Interventions
BEHAVIORALMindfulness Relaxation
Participate in mindfulness program
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
OTHERGroup II (mindfulness waitlist)
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.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall accrual | Up to 12 weeks | Will calculate means, frequencies, and 90% confidence intervals (CIs), as applicable. |
| Attrition | Up to 12 weeks | Will calculate means, frequencies, and 90% CIs, as applicable. |
| Adherence | Up to 12 weeks | Will calculate means, frequencies, and 90% CIs, as applicable. |
| Acceptability | Up to 12 weeks | Will calculate means, frequencies, and 90% CIs, as applicable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient and caregiver psychological distress | 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. |
| Quality of life questionnaire | 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. |
| Patient cancer symptoms | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLarkin Strong
M.D. Anderson Cancer Center
Outcome results
None listed