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NCT Number: NCT07248111

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

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).

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Key information

Conditions

Professional Quality of Life Behavior Emotional Regulation Neoplasms Oncology Palliative Care Self-Control Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, Italy

Location contact

Loredana Buonaccorso, MD

CONTACT

[email protected]

Loredana Buonaccorso, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Turola, Project & Data Manager

CONTACT

[email protected]

Loredana Buonaccorso, MD

CONTACT

[email protected]

+39 0522 285804

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Collaborators

  • St. John's University, Rome, Italy

Registry information

Official study title

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

Acronym: MCCP

Important dates

Study start
2027
Primary completion
2027
Study completion
2028
First posted
Nov 25, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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