Professional Quality of LifeMCCPNCT07248111
Effectiveness of the Mindful Compassion Care Program for Healthcare Professionals in Oncology and Palliative Care
A study testing MCCP in people with Professional Quality of Life and Palliative Care, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Professional Quality of Life, Palliative Care, Oncology
- What is being tested?
- MCCP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2027to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elena Turola, Project & Data Manager contact
Italy1 site
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia
Loredana Buonaccorso, MD, loredana.buonaccorso@ausl.re.it
Loredana Buonaccorso, MD
About this study
Official title: 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).
Read the 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
- Being tested
- MCCP
- Keywords
- mindfulness, self-compassion, emotional regulation, supportive care, mental health promotion
- Medical subject headings
- Neoplasms, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCCPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Compassion Care Program (MCCP) | Experimental | Not described Receives: Behavioral: MCCP |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 8 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: baseline, 8 weeks, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study startDec 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Professional Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Collaborators
- St. John's University, Rome, Italy
- Responsible party
- Sponsor
- Investigators
- Loredana Buonaccorso, MD, Principal investigator, Azienda USL Reggio Emilia - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248111
- Sponsor's protocol ID
- 390/2025/SPER/IRCCS
- Acronym
- MCCP
- Status last verified
- Sep 2025
- First submitted
- 18 Nov 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28683799Watts 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.
PubMed 33666500Kamal 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.
PubMed 31778784Hlubocky 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.
PubMed 32223701Ho 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.
PubMed 34744918
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Mindful Compassion Care Program for Healthcare Professionals in Oncology and Palliative Care: a Randomized Controlled Trial With a Qualitative Component
- ClinicalTrials.gov ID
- NCT07248111
- Acronym / sponsor ID
- MCCP / 390/2025/SPER/IRCCS
- Conditions
- Professional Quality of Life, Palliative Care, Oncology
- Keywords
- mindfulness, self-compassion, emotional regulation, supportive care, mental health promotion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Collaborators
- St. John's University, Rome, Italy
- Study start
- Dec 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Compassion Care Program (MCCP) | Experimental | Behavioral: MCCP |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCCPThe 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. | Behavioural | Mindful Compassion Care Program (MCCP) |
Primary outcome
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.
2 secondary outcomes
Improvement in Professional Quality of Life
Time frame: baseline, 8 weeks, 6 month
Improvement in Self-Compassion
Time frame: baseline, 8 weeks, 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 28683799Orellana-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.
- Background: PubMed 33666500Watts 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.
- Background: PubMed 31778784Kamal 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.
- Background: PubMed 32223701Hlubocky 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.
- Background: PubMed 34744918Ho 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elena Turola, Project & Data Manager contact
Loredana Buonaccorso, MD principal investigator
Azienda USL Reggio Emilia - IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCCP in people with Professional Quality of Life and Palliative Care, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Loredana Buonaccorso, MD (+39 0522 285804, loredana.buonaccorso@ausl.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in affectivity (Positive and Negative Affect Schedule, PANAS composite score: Positive - Negative) (time frame: baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07248111, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.