Quality of Life Clinical Trial
— MEANINGOfficial title:
Mindfulness to Enhance Quality of Life and Support Advance Care Planning (MEANING): A Randomized Controlled Pilot Trial for Adults With Metastatic Cancer and Their Family Caregivers
Verified date | August 2020 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 malignancies and their family caregivers.
Status | Completed |
Enrollment | 108 |
Est. completion date | December 11, 2017 |
Est. primary completion date | December 11, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in quality of life (QoL) for Patients | QoL for patients will be assessed with the McGill Quality of Life Inventory. | Baseline, 6 weeks, and 10 weeks | |
Primary | Change from baseline in quality of life (QoL) for Family Caregivers | QoL for family caregivers will be assessed with the Caregiver Quality of Life - Cancer scale (CQoLC). | Baseline, 6 weeks, and 10 weeks | |
Secondary | Change from baseline in advance care planning (ACP) stage of change | ACP stage of change will be assessed by a measure modified from Fried et. al assessing stage of change for 3 advance care planning behaviors (completing a living will, medical power of attorney form, or POLST form; patient only measure). | Baseline, 6 weeks, and 10 weeks | |
Secondary | Change from baseline in advance care planning (ACP) engagement | ACP engagement (self-efficacy, readiness) will be measured using 2 subscales of the Advance Care Planning Engagement Survey (patient only measure). | Baseline, 6 weeks, and 10 weeks | |
Secondary | Change from baseline in caregiver burden | Caregiver burden will be measured using the Zarit Burden Interview (family caregiver measure only) | Baseline, 6 weeks, and 10 weeks | |
Secondary | Change from baseline in avoidant coping | Avoidant coping will be assessed using the Mini-MAC Cognitive Avoidance subscale | Baseline, 6 weeks, and 10 weeks | |
Secondary | Change from baseline in avoidant coping | Avoidant coping will be assessed using the Brief COPE Self-Distraction, Denial, and Behavioral Disengagement subscales | Baseline, 6 weeks, and 10 weeks | |
Secondary | Change from baseline in depressive symptoms | Depressive symptoms will be assessed using the PHQ-8 | Baseline, 6 weeks, and 10 weeks | |
Secondary | Change from baseline in anxiety | Anxiety will be assessed using the GAD-7 | Baseline, 6 weeks, and 10 weeks | |
Secondary | Change from baseline in spiritual well-being | Spiritual well-being will be measured using the FACIT-SP. | Baseline, 6 weeks, and 10 weeks | |
Secondary | Change from baseline in sleep disturbance | Sleep disturbance will be assessed using the PROMIS Sleep Disturbance. | Baseline, 6 weeks, and 10 weeks | |
Secondary | Change from baseline in family communication | Family communication will be assessed using the Social Constraint Scale | Baseline, 6 weeks, and 10 weeks | |
Secondary | Change from baseline in interpersonal closeness | Interpersonal closeness will be assessed using the Perceived Interpersonal Closeness Scale. | Baseline, 6 weeks, and 10 weeks | |
Secondary | Change from baseline in acceptance of illness | Acceptance of illness will be assessed using the PEACE Scale. | Baseline, 6 weeks, and 10 weeks | |
Secondary | Change from baseline in mindfulness | Mindfulness will be assessed using the FFMQ-SF Non-reactivity to Internal Experience and Acting with Awareness subscales. | Baseline, 6 weeks, and 10 weeks | |
Secondary | Distress Thermometer | Distress will be assessed using the Distress Thermometer. | Baseline, 6 weeks, and 10 weeks | |
Secondary | Intervention satisfaction and helpfulness | Satisfaction and helpfulness with the Mindfulness intervention will be assessed using single-item investigator-created 7- and 10-point Likert scales, respectively (Mindfulness group only). | 6 weeks |
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