Clinical trial · Interventional
Mindfulness to Enhance Quality of Life and Support Advance Care Planning
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
NCT03257007CI-TRIAL-00046581MEANINGcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advance Care Planning | — | UNRESOLVED | — |
| Family Caregiver | — | UNRESOLVED | — |
| Meditation | — | UNRESOLVED | — |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Mindfulness | — | UNRESOLVED | — |
| Palliative Care | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Supportive Care | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mindfulness | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Participants assigned to Usual Care will continue to receive standard care from their oncology team, including access to supportive care from oncology social workers. At the end of the study, usual care dyads will receive a packet of informational materials on mindfulness meditation, receive a CD with 5 mindfulness meditation practices, and meet with the study interventionist for guidance on how to use the materials and mindfulness recordings to their advantage in coping with cancer-related challenges.
- type
- ACTIVE_COMPARATOR
- label
- Mindfulness
- description
- The Mindfulness intervention will consist of six 2-hour sessions that will include guided mindfulness practices, didactics, and group discussion. The course curriculum is modeled on the Mindfulness-Based Stress Reduction program which involves intensive experiential training of participants in secular mindfulness meditation practices (i.e., body scan, sitting meditation, gentle hatha yoga with chair adaptations, compassion meditation), with an emphasis on embodying interpersonal mindfulness in dialogue.
- interventionNames
- Behavioral: Mindfulness
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDMosher CE, Beck-Coon KA, Wu W, Lewson AB, Stutz PV, Brown LF, Tang Q, Helft PR, Levoy K, Hickman SE, Johns SA. Mindfulness to enhance quality of life and support advance care planning: a pilot randomized controlled trial for adults with advanced cancer and their family caregivers. BMC Palliat Care. 2024 Sep 28;23(1):232. doi: 10.1186/s12904-024-01564-7. PMID 39342143