Effectiveness of the Mindful Compassion Care Program for Healthcare Professionals in Oncology and Palliative Care

NCT07248111 | Not Yet Recruiting

• 1 other identifier: 390/2025/SPER/IRCCS
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the effectiveness of the Mindful Compassion Care Program (MCCP), a mindfulness- and compassion-based intervention designed to enhance the emotional and professional well-being of healthcare professionals (HPs). The study adopts a multi-center, open-label, randomized, parallel-group, superiority design and includes HPs (physicians, nurses, and nursing assistants) involved in the clinical care of cancer patients across different settings and disease phases. Eligible participants must not have attended MBSR or other mindfulness-/compassion-based interventions in the preceding six months. The RCT has a primary objective of assessing the MCCP's effectiveness in increasing positive emotions and reducing negative emotions among HPs working in oncology and palliative care. Secondary objectives include evaluating improvements in professional quality of life and self-compassion. After providing informed consent, HPs will be randomized to receive either the MCCP (experimental group) or no intervention (control group).

Conditions

Professional Quality of Life; Palliative Care; Oncology

Keywords

mindfulness; self-compassion; emotional regulation; supportive care; mental health promotion

Outcome Measures

Primary Outcomes (1)

• Change in affectivity (Positive and Negative Affect Schedule, PANAS composite score: Positive - Negative)

  The PANAS is a 20-item self-reported questionnaire assessing positive and negative emotions. The composite score (Positive - Negative) will be calculated for each participant. Positive affectivity refers to emotions such as joy or contentment, whereas negative affectivity refers to emotions such as anger, fear, or sadness. Higher scores indicate greater positive affectivity.

  baseline, 8 weeks

Secondary Outcomes (2)

• Improvement in Professional Quality of Life

  baseline, 8 weeks, 6 month

• Improvement in Self-Compassion

  baseline, 8 weeks, 6 month

Study Arms (2)

Mindful Compassion Care Program (MCCP)

EXPERIMENTAL

Behavioral: MCCP

Control group

NO INTERVENTION

Interventions

MCCP BEHAVIORAL

The MCCP is a structured seven-week group intervention integrating elements from Mindfulness-Based Cognitive Therapy (MBCT), Mindfulness-Based Stress Reduction (MBSR), and Compassion-Focused Therapy (CFT). The program consists of six 90-minute weekly sessions plus one intensive 4.5-hour session. Sessions include mindfulness meditation, breathing exercises, yoga practices, imagery techniques, and compassion-focused activities. Daily home practice is supported through guided audio tracks and worksheets. The intervention is delivered in small groups (up to 15 participants) by psychotherapists specifically trained for the MCCP as part of the study.

Mindful Compassion Care Program (MCCP)

Eligibility Criteria

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

You may qualify if:

• Being a healthcare professional (physicians, nurses, or nursing assistants) involved in the clinical management of cancer patients across different care settings and illness phases.
• Age ≥ 18 years

You may not qualify if:

• HPs must not have attended MBSR or other mindfulness/compassion-based interventions, including in educational or clinical settings, involving activities similar to those in the present study in the previous six months.

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead
• St. John's University, Rome, Italy: collaborator

Study Sites (1)

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, Italy

Location

Related Publications (5)

• Orellana-Rios CL, Radbruch L, Kern M, Regel YU, Anton A, Sinclair S, Schmidt S. Mindfulness and compassion-oriented practices at work reduce distress and enhance self-care of palliative care teams: a mixed-method evaluation of an "on the job" program. BMC Palliat Care. 2017 Jul 6;17(1):3. doi: 10.1186/s12904-017-0219-7.

  PMID: 28683799 BACKGROUND

• Watts KJ, O'Connor M, Johnson CE, Breen LJ, Kane RT, Choules K, Doyle C, Buchanan G, Yuen K. Mindfulness-Based Compassion Training for Health Professionals Providing End-of-Life Care: Impact, Feasibility, and Acceptability. J Palliat Med. 2021 Sep;24(9):1364-1374. doi: 10.1089/jpm.2020.0358. Epub 2021 Mar 5.

  PMID: 33666500 BACKGROUND

• Kamal AH, Bull JH, Wolf SP, Swetz KM, Shanafelt TD, Ast K, Kavalieratos D, Sinclair CT. Prevalence and Predictors of Burnout Among Hospice and Palliative Care Clinicians in the U.S. J Pain Symptom Manage. 2020 May;59(5):e6-e13. doi: 10.1016/j.jpainsymman.2019.11.017. Epub 2019 Nov 26.

  PMID: 31778784 BACKGROUND

• Hlubocky FJ, Taylor LP, Marron JM, Spence RA, McGinnis MM, Brown RF, McFarland DC, Tetzlaff ED, Gallagher CM, Rosenberg AR, Popp B, Dragnev K, Bosserman LD, Dudzinski DM, Smith S, Chatwal M, Patel MI, Markham MJ, Levit K, Bruera E, Epstein RM, Brown M, Back AL, Shanafelt TD, Kamal AH. A Call to Action: Ethics Committee Roundtable Recommendations for Addressing Burnout and Moral Distress in Oncology. JCO Oncol Pract. 2020 Apr;16(4):191-199. doi: 10.1200/JOP.19.00806. Epub 2020 Mar 30.

  PMID: 32223701 BACKGROUND

• Ho AHY, Tan-Ho G, Ngo TA, Ong G, Chong PH, Dignadice D, Potash J. A Novel Mindful-Compassion Art-Based Therapy for Reducing Burnout and Promoting Resilience Among Healthcare Workers: Findings From a Waitlist Randomized Control Trial. Front Psychol. 2021 Oct 21;12:744443. doi: 10.3389/fpsyg.2021.744443. eCollection 2021.

  PMID: 34744918 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Loredana Buonaccorso, MD

  Azienda USL - IRCCS di Reggio Emilia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Loredana Buonaccorso, MD

CONTACT

+39 0522 285804; loredana.buonaccorso@ausl.re.it

Elena Turola, Project & Data Manager

CONTACT

elena.turola@ausl.re.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start (Estimated): December 1, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)