Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-02774 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-1070 | Other Identifier | M D Anderson Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Relaxation | Behavioral | Participate in mindfulness program |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 6 and 12 weeks |
| Quality of life questionnaire |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Larkin Strong | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| 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. |
|
Will examine means, SDs, and distributions of survey measures for ceiling/floor effects and restrictions in range and examine change over time. |
| 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. | At 6 and 12 weeks |