NCT07248111

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Azienda USL Reggio Emilia - IRCCS · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

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.

Conditions

• Professional Quality of Life
• Palliative Care
• Oncology

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-11-25
• Last updated: 2025-12-02

Locations

1 site across 1 country: Italy