Back to results

Mindfulness to Enhance Quality of Life and Support Advance Care Planning (MEANING)

Primary Purpose

Mindfulness, Meditation, Metastatic Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindfulness

About this trial

This is an interventional supportive care trial for Mindfulness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Indiana University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual Care

Mindfulness

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in quality of life (QoL) for Patients

QoL for patients will be assessed with the McGill Quality of Life Inventory.

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).

Secondary Outcome Measures

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).

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).

Change from baseline in caregiver burden

Caregiver burden will be measured using the Zarit Burden Interview (family caregiver measure only)

Change from baseline in avoidant coping

Avoidant coping will be assessed using the Mini-MAC Cognitive Avoidance subscale

Change from baseline in avoidant coping

Avoidant coping will be assessed using the Brief COPE Self-Distraction, Denial, and Behavioral Disengagement subscales

Change from baseline in depressive symptoms

Depressive symptoms will be assessed using the PHQ-8

Change from baseline in anxiety

Anxiety will be assessed using the GAD-7

Change from baseline in spiritual well-being

Spiritual well-being will be measured using the FACIT-SP.

Change from baseline in sleep disturbance

Sleep disturbance will be assessed using the PROMIS Sleep Disturbance.

Change from baseline in family communication

Family communication will be assessed using the Social Constraint Scale

Change from baseline in interpersonal closeness

Interpersonal closeness will be assessed using the Perceived Interpersonal Closeness Scale.

Change from baseline in acceptance of illness

Acceptance of illness will be assessed using the PEACE Scale.

Change from baseline in mindfulness

Mindfulness will be assessed using the FFMQ-SF Non-reactivity to Internal Experience and Acting with Awareness subscales.

Distress Thermometer

Distress will be assessed using the Distress Thermometer.

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).

Full Information

NCT ID

NCT03257007

First Posted

August 16, 2017

Last Updated

August 10, 2020

Sponsor

Indiana University

1. Study Identification

Unique Protocol Identification Number

NCT03257007

Brief Title

Mindfulness to Enhance Quality of Life and Support Advance Care Planning

Acronym

MEANING

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

May 9, 2017 (Actual)

Primary Completion Date

December 11, 2017 (Actual)

Study Completion Date

December 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Masking Description

Participants are blind to study hypotheses.

Allocation

Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

Arm Title

Mindfulness

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline in quality of life (QoL) for Patients

Description

QoL for patients will be assessed with the McGill Quality of Life Inventory.

Time Frame