Mindfulness to Enhance Quality of Life and Support Advance Care Planning

NCT03257007 | Completed DMC

• 1 other identifier: 1702223546
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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 malignancies and their family caregivers.

Conditions

Mindfulness; Meditation; Metastatic Cancer; Quality of Life; Advance Care Planning; Palliative Care; Family Caregiver; Supportive Care

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (15)

• Change from baseline in advance care planning (ACP) stage of change

  Baseline, 6 weeks, and 10 weeks

• Change from baseline in advance care planning (ACP) engagement

  Baseline, 6 weeks, and 10 weeks

• Change from baseline in caregiver burden

  Baseline, 6 weeks, and 10 weeks

• Change from baseline in avoidant coping

  Baseline, 6 weeks, and 10 weeks

• Change from baseline in avoidant coping

  Baseline, 6 weeks, and 10 weeks

Study Arms (2)

Usual Care

NO INTERVENTION

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.

Mindfulness

ACTIVE COMPARATOR

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.

Behavioral: Mindfulness

Interventions

Mindfulness BEHAVIORAL

The Mindfulness intervention sessions are designed to cultivate present-moment awareness in everyday life to facilitate adaptive and non-reactive relating to thoughts, feelings, and bodily sensations. Participants will be provided with 10-20 minute audio recordings of each of 5 mindfulness practices covered in class, recorded in the facilitator's voice. Participants will be encouraged to practice mindfulness at home 10-20 minutes per day, 6 days per week. Participants will be provided with weekly diaries on which to record type and amount of home practice of mindfulness skills.

Mindfulness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Mosher 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 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Shelley A Johns, PsyD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants are blind to study hypotheses.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Research Scientist

Model Details: Participants will be assigned in equal numbers using block randomization to the mindfulness intervention or usual care. The course curriculum for the mindfulness intervention 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.

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 22, 2017
• Study Start: May 9, 2017
• Primary Completion: December 11, 2017
• Study Completion: December 11, 2017
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

US (1)