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

April 28, 2026 updated by: Azienda USL Reggio Emilia - IRCCS

Effectiveness of the Mindful Compassion Care Program for Healthcare Professionals in Oncology and Palliative Care: a Randomized Controlled Trial With a Qualitative Component

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study includes an embedded qualitative component designed to explore the acceptability and perceived value of the MCCP from the perspective of healthcare professionals who received the intervention. Qualitative data will be collected through focus groups conducted with a purposive sub-sample of RCT participants. Participation in the focus groups will be voluntary. This purposive sampling strategy is appropriate as it allows the inclusion of individuals capable of providing rich, relevant, and diverse insights into their experiences with the MCCP and its perceived impact.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Reggio Emilia, Italy
        • Azienda USL IRCCS Di Reggio Emilia
        • Contact:
        • Principal Investigator:
          • Loredana Buonaccorso, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Mindful Compassion Care Program (MCCP)
Behavioral: MCCP
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in affectivity (Positive and Negative Affect Schedule, PANAS composite score: Positive - Negative)
Time Frame: baseline, 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Professional Quality of Life
Time Frame: baseline, 8 weeks, 6 month
Measured using the Professional Quality of Life Scale (ProQOL, Version 5), a 30-item self-reported questionnaire. It assesses three subscales: Compassion Satisfaction (CS), Burnout, and Secondary Traumatic Stress (STS). Higher CS scores indicate improved professional well-being, while lower Burnout and STS scores indicate reduced professional fatigue and stress. The change in scores from T0 to T1 and T2 will quantify improvement.
baseline, 8 weeks, 6 month
Improvement in Self-Compassion
Time Frame: baseline, 8 weeks, 6 month
Measured using the Self-Compassion Scale (SCS), a 26-item self-administered questionnaire covering six components: Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness, and Over-Identification. The total score is the mean of the six subscales (range 1-5), with higher scores indicating greater self-compassion. The change in scores from T0 to T1 and T2 will indicate the degree of improvement.
baseline, 8 weeks, 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda USL Reggio Emilia - IRCCS

Collaborators

St. John's University, Rome, Italy

Investigators

  • Principal Investigator: Loredana Buonaccorso, MD, Azienda USL - IRCCS di Reggio Emilia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2027

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 390/2025/SPER/IRCCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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