Status:
COMPLETED
Mindfulness to Enhance Quality of Life and Support Advance Care Planning
Lead Sponsor:
Indiana University
Conditions:
Mindfulness
Meditation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The MEANING trial is a randomized controlled mixed methods pilot designed to compare a novel mindfulness meditation-based intervention (MEANING) to usual care for adults with advanced-stage solid mali...
Detailed Description
Mindfulness meditation practices have reduced emotional distress, avoidant coping, and improved spiritual well-being in adult cancer patients. These beneficial effects may occur through present-moment...
Eligibility Criteria
Inclusion
- Inclusion Criteria-Patients
- Patient is at least 18 years of age.
- Patient is at least 3 weeks post-diagnosis of an incurable (locally advanced or metastatic) solid malignancy.
- Patient's attending medical oncologist would not be surprised if the patient died in the next 12 months.
- Patient has not completed a POST form.
- Patient scores ≥ 7 on the Mini-Mental Adjustment to Cancer cognitive avoidance subscale.
- Patient is willing and able to consent and travel to the class location for 6 weekly 2-hour sessions.
- Patient has a family member or close friend eligible and interested in participating in the study.
- Patient has adequate English fluency for completion of data collection
- Inclusion Criteria-Family Care Givers (FCG)
- FCG is at least 18 years of age.
- FCG has been invited to participate in the trial with a patient who meets eligibility criteria above.
- FCG is willing and able to consent and travel to the class location for 6 weekly 2-hour sessions.
- FCG has adequate English fluency for completion of data collection
- Exclusion Criteria-Patients
- Patient reports a score of \> 2 on the Activities and Function item from the Patient Generated Subjective Global Assessment91 (PG-SGA; the patient-reported version of the Eastern Cooperative Oncology Group score).
- Patient makes 3 or more errors on a validated 6-item cognitive screener or exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation.
- Currently receiving hospice care (patients who enroll in hospice during the trial will have the option of continuing trial participation).
- Exclusion Criteria-FCGs
- • FCG exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation.
Exclusion
Key Trial Info
Start Date :
May 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2017
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT03257007
Start Date
May 9 2017
End Date
December 11 2017
Last Update
August 12 2020
Active Locations (1)
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1
Indiana University
Indianapolis, Indiana, United States, 46202