Mindfulness to Enhance Quality of Life and Support Advance Care Planning

NCT ID: NCT03257007

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-09
• Study Completion Date: 2017-12-11

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.

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 acceptance of unpleasant thoughts, feelings, and circumstances and adaptive coping through self-awareness, self-regulation, and self-transcendence. Most mindfulness trials in cancer have focused on early-stage survivors; however, preliminary evidence suggests that mindfulness may help reduce distress in patients with advanced cancer and their family caregivers (FCGs).

Sixty patients with an advanced-stage solid malignancy and their FCGs (60 dyads) will be randomized in equal numbers to receive either the 6-week mindfulness intervention or usual care. Both groups will receive standard cancer care throughout the study period. Dyads randomized to the mindfulness arm will learn mindfulness meditation practices (e.g., body scan, sitting meditation) and mindful communication practices to enhance quality of life, support advance care planning engagement, and improve a variety of secondary outcomes.

The study will use a mixed methods 2-arm randomized design to examine the effects of the mindfulness intervention compared to usual care and seek to explain trial results using insights gleaned from post-intervention qualitative interviews.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mindfulness

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.

Group Type: ACTIVE_COMPARATOR

Mindfulness

Intervention Type: 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.

Interventions

Mindfulness

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Shelley Johns

Assistant Professor of Medicine, Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shelley A Johns, PsyD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana University

Indianapolis, Indiana, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39342143 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1702223546

Identifier Type: -

Identifier Source: org_study_id