COMpassion FOcused Therapy and Breathing Pattern REtraining After Cancer Recurrence (COMFORT)

University College Dublin

Status: Enrolling

Conditions: Cancer Recurrence; Psychological Distress

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05518591

COV21LYN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

CFT & BPR

Experimental group

Description:

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.

Treatment:

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

Treatment As Usual

No Intervention group

Description:

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.