Clinical trial · Interventional
Compassion Meditation for Cancer Survivor-Caregiver Dyads
Compassion Meditation for Cancer Survivor-Caregiver Dyads: Feasibility and Preliminary Efficacy of Cognitively-Based Compassion Training (CBCT®) for Solid Tumor Cancer Survivors and Their Informal Caregivers
- 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)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Survivors | — | UNRESOLVED | — |
| Informal Cancer Caregivers (Family and Friends of Cancer Survivors) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CHE (Cancer Health Education) | Behavioral | — | UNRESOLVED |
| Cognitively-Based Compassion Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cognitively-Based Compassion Training
- description
- Cancer survivors and their informal caregivers (family and close friends), one of whom has at least mild depression and/or anxiety features (determined by PROMIS Depression 4a and PROMIS Anxiety 4a, respectively) who are randomized to CBCT®.
- interventionNames
- Behavioral: Cognitively-Based Compassion Training
- type
- ACTIVE_COMPARATOR
- label
- CHE (Cancer Health Education)
- description
- Cancer survivors and their informal caregivers (family and close friends), one of whom has at least mild depression and/or anxiety features (determined by PROMIS Depression 4a and PROMIS Anxiety 4a, respectively) who are randomized to CHE.
- interventionNames
- Behavioral: CHE (Cancer Health Education)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: Cancer survivor inclusion criteria: 1) age 21 or older, 2) have a solid tumor cancer diagnosis, 3) have completed treatments (surgery, radiation, chemotherapy) except for hormonal therapies (e.g. aromatase inhibitors, androgen suppression therapy) a minimum of 3 months and a maximum of 10 years before starting CBCT® or CHE, 4) able to speak and understand English, and 5) able to travel to a centralized location to attend CBCT® or attention control classes. Informal caregiver inclusion criteria will be: 1) named by the cancer survivor, 2) age 21 or older, 3) able to speak and understand English, 4) cognitively oriented in time, place, and person, and 5) able to travel to a centralized location to attend intervention classes with their solid tumor cancer survivor. Informal caregivers will be excluded if they have ongoing or past regular compassion meditation experience in the last 4 years. In addition to these criteria, either the cancer survivor or the informal caregiver must report at least mild anxiety (PROMIS anxiety 4-item raw score \> 6) and/ or mild depressive symptoms (PROMIS anxiety 4-item raw score \> 6). Exclusion Criteria: Cancer survivor exclusionary factors: 1) diagnosis of major mental illness, 2) nursing home resident, and 3) have ongoing or past regular compassion meditation experience in the last 4 years (i.e. more than two compassion meditation session \[completed or attempted\] per year, either with a group or individually). Informal caregiver exclusionary factors: 1) diagnosis of major mental illness, 2) nursing home resident, and 3) have ongoing or past regular compassion meditation experience in the last 4 years (i.e. more than two compassion meditation session \[completed or attempted\] per year, either with a group or individually).
References
Publications (1)
- DERIVEDPace TWW, Dodds SE, Sikorskii A, Badger TA, Segrin C, Negi LT, Harrison T, Crane TE. Cognitively-Based Compassion Training versus cancer health education to improve health-related quality of life in survivors of solid tumor cancers and their informal caregivers: study protocol for a randomized controlled pilot trial. Trials. 2019 Apr 29;20(1):247. doi: 10.1186/s13063-019-3320-9. PMID 31036091