COMpassion FOcused Therapy and Breathing Pattern REtraining After Cancer Recurrence

NCT ID: NCT05518591

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-25
• Study Completion Date: 2023-06-30

Brief Summary

The purpose of this study is to investigate how effective a particular psychological intervention is at reducing psychological distress for people who were diagnosed with cancer 'recurrence' since the beginning of the COVID pandemic.

Detailed Description

This study plans to study how effective a particular psychological intervention is at reducing psychological distress for people who were diagnosed with cancer 'recurrence' since the beginning of the pandemic, having previously been diagnosed with cancer. We know that a cancer diagnosis can often result in significant psychological distress. After or during treatment for cancer, individuals often experience a 'fear of recurrence', which should it occur, often results in a state of mental anguish that is described as being more punishing than the initial diagnosis itself. Being diagnosed with a cancer recurrence diagnosis can trigger marked negative psychological symptoms, including distress, uncertainty, traumatic distress and adjustment problems, with psychological recovery from this diagnosis often being slower than that of the initial cancer diagnosis. The COVID-19 pandemic has affected these patients further, in terms of restricted access to healthcare, reduced social supports, and greater levels of treatment uncertainty. Our research team has designed a psychological intervention that is specifically aimed to help some of these issues. It's a 6-week online group intervention using a 'compassion focused therapy' approach, coupled with specialised breathing techniques to reduce bodily distress. It is being done online due to ongoing concerns around COVID but also to eliminate geographical and/or commuting barriers. It is our expectation that those receiving the psychological intervention will experience noticeable reductions in measures of psychological distress compared to those who are receiving regular treatment. It is our hope that the outcomes of this study will inform how best to help patients facing into cancer recurrence at a national level.

Conditions

Psychological Distress; Cancer Recurrence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

CFT & BPR

6-week, virtual, psychological therapy group involving compassion focused therapy and breathing pattern retraining. This group involves exercises in practicing self-compassion, emotional regulation, and breathing retraining.

Group Type: EXPERIMENTAL

Compassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (BPR)

Intervention Type: BEHAVIORAL

Study participants in the experimental arm of the study are being asked to take part in a 6-week, virtual, psychological therapy group involving compassion focused therapy and breathing pattern retraining. This group involves exercises in practicing self-compassion, emotional regulation, and breathing retraining. Each group session lasts less than two hours, per week.

Treatment As Usual

Those in the treatment as usual arm are not being asked to engage in anything additional to their regular treatment plan. They will, however, be given the option to participate in the psychological intervention after the study has ended, if they elect to do so.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Compassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (BPR)

Study participants in the experimental arm of the study are being asked to take part in a 6-week, virtual, psychological therapy group involving compassion focused therapy and breathing pattern retraining. This group involves exercises in practicing self-compassion, emotional regulation, and breathing retraining. Each group session lasts less than two hours, per week.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• adults aged 18 or older
• pre-existing cancer diagnosis
• diagnosis of cancer recurrence during COVID-19 (March 2020 onwards)
• Living in Ireland
• English speaking / fluency
• Access to web / tech support

Exclusion Criteria

• A score <4 on the Distress Thermometer
• Patient non-consent
• The presence of a severe mental illness (such as schizophrenia, personality disorder or active illness)
• Known or suspected drug or alcohol abuse problems within past 3 months
• Inability to follow the study procedures e.g. dementia or non-fluency of English
• Life expectancy <3 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mater Misericordiae University Hospital

OTHER

Sponsor Role: collaborator

Irish Cancer Society

OTHER

Sponsor Role: collaborator

University College Dublin

OTHER

Sponsor Role: lead

Responsible Party

Donal Brennan

Professor Donal Brennan

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sinead Lynch, PhD

Role: PRINCIPAL_INVESTIGATOR

MMUH

Locations

Mater Misericordiae University Hospital

Dublin, , Ireland

Site Status: RECRUITING

Countries

Ireland

Central Contacts

Donal Brennan, PhD

Role: CONTACT

donal.brennan@ucd.ie

01 716 4576

Sinead Lynch, PhD

Role: CONTACT

SineadLynch@mater.ie

087 803 9068

Facility Contacts

Donal Brennan, PhD

Role: primary

donal.brennan@ucd.ie

01 716 4576

References

Lynch S, Lowry D, Finnerty C, O'Meara Y, Brennan D. The COMFORT trial: a randomised control trial comparing group-based COMpassion-FOcussed therapy and breathing pattern ReTraining with treatment as usual on the psychological functioning of patients diagnosed with cancer recurrence during COVID. Trials. 2023 Feb 6;24(1):89. doi: 10.1186/s13063-023-07088-4.

Reference Type: DERIVED

PMID: 36747246 (View on PubMed)

Other Identifiers

COV21LYN

Identifier Type: -

Identifier Source: org_study_id