Compassion Meditation for Cancer Survivor-Caregiver Dyads

NCT03459781 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2022-03-10

No results posted yet for this study

Summary

Survivors of solid tumor cancers and their informal caregivers (family, friends) experience impairments in health-related quality of life (HRQOL) including disruptions in psychological, physical, social, and spiritual well-being. Our prior work demonstrates that impairments in depression, anxiety, fatigue, and negative affect experienced by cancer survivors across time are interdependent those experienced by their informal caregivers. These findings suggest that interventions directed simultaneously toward both members of the cancer survivor-caregiver dyad may be especially impactful in improving HRQOL in cancer survivors and informal caregivers. Although a number of interventions have been developed and tested to support the survivor or the caregiver, few have attempted to simultaneously intervene with both to improve HRQOL within the collective survivor-caregiver dyad. CBCT®, Cognitively-Based Compassion Training (already piloted by members of this team with breast cancer survivors, is an 8-week manualized meditation-based program that starts with attention and mindfulness training and builds to contemplation about compassion for the self and others. The proposed pilot feasibility study builds upon this work to intervene with caregivers in addition to survivors of solid tumor cancers. The major aim of the proposed project is to test the feasibility and acceptability of CBCT® for survivors of solid tumor cancer and their informal caregivers after the end of cancer treatment. The project will also determine in a preliminary manner whether or not CBCT® (compared to a cancer health education \[CHE\] comparison group) has a positive impact on different measures of HRQOL (e.g. features of depression and anxiety, fatigue, social isolation), stress-related biomarkers of inflammation and cortisol, and assessments related to healthcare utilization.

IMPORTANT READER NOTE: ==\> A prior version of this study protocol on clinicaltrials.gov incorrectly stated information about interpretation of scores of the Morisky Medication Adherence Scale-8 (MMAS-8). ==\> Individuals interested in using the MMAS-8 are directed to https://morisky.org for information about the scale, as well as for licensing and other requirements for using the MMAS-8 in their research or clinical practice. Dr. Pace and his colleagues sincerely regret any incorrect information posted previously about the MMAS-8 on this clinicaltrials.gov trial website.

Conditions

  • Cancer Survivors
  • Informal Cancer Caregivers (Family and Friends of Cancer Survivors)

Interventions

BEHAVIORAL

Cognitively-Based Compassion Training

CBCT® was designed at Emory University by Lobsang Tenzin Negi. CBCT® is a secular adaptation of techniques derived from traditional Tibetan Buddhist methods for cultivating compassion known as lo-jong. Over the course of 8 weeks there will a total of 8 CBCT® sessions, one session per week, led by the CBCT® instructor. Dyads will attend the weekly CBCT® classes together. Each weekly session will last for 90 minutes and will begin with brief meditation to focus attention. The instructor will then articulate content and goals of the current week, after which a group discussion led by the instructor will take place. A session will end with a 20-30 minute meditation. Dyads will be encouraged to practice a minimum of 10 minutes per day at home, and together as a dyad if possible.

BEHAVIORAL

CHE (Cancer Health Education)

The cancer health education (CHE) intervention is an adaptation of the in-person program called Health Discussion, a protocol used by our group previously. The CHE will focus on relevant topics to health and cancer including 1) cancer advocacy, 2) health and cancer biology, 3) nutrition, 4) lifestyle interventions such as physical activity and goals for physical activity, 5) the importance of good sleep, 6) the impact of stress, and 7) mental health and social support. CHE will also discuss current events related to cancer. Over the course of 8 weeks there will be a total of 8 sessions, one session per week. Each session will last for approximately 90 minutes.

Sponsors & Collaborators

  • Thaddeus Pace

    lead OTHER

Principal Investigators

  • Thaddeus Pace, PhD · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-14
Primary Completion
2020-01-11
Completion
2020-01-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03459781 on ClinicalTrials.gov