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

N/ANot Yet RecruitingNCT07248111

Azienda USL Reggio Emilia - IRCCS160 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

160

Interventions

MCCPBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: baseline, 8 weeks

Secondary Outcomes

Improvement in Professional Quality of Life

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.

Time frame: baseline, 8 weeks, 6 month

Improvement in Self-Compassion

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.