COMpassion FOcused Therapy and Breathing Pattern REtraining After Cancer Recurrence

Not Applicable

• Conditions: Psychological Distress; Cancer Recurrence
• Interventions: Behavioral: Compassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (BPR)

• Registration Number: NCT05518591
• Lead Sponsor: University College Dublin

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.

Study Timeline

• Study Start: 2022-03-25
• Status Verified: 2022-08
• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Last Update Submitted: 2022-08-24
• Study First Posted: 2022-08-26
• Last Update Posted: 2022-08-26
• Primary Completion: 2023-03
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CFT & BPR	Compassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (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.

Primary Outcome Measures

Name	Time	Method
Overall Distress Score	12 weeks post completion of intervention	The primary outcome is the patient's overall distress score, based on the Distress Thermometer (DT)

Secondary Outcome Measures

Name	Time	Method
Changes in depressive symptoms	12 weeks post completion of intervention	Patient Health Questionnaire-9 (PHQ-9) will assesses symptoms of depression
Changes in traumatic distress	12 weeks post completion of intervention	Impact of Event Scales- Revised (IES-R) will measure the amount of distress that a subject associates with a specific event.
Mental Adjustment to Cancer Recurrence	12 weeks post completion of intervention	Mini-Mental Adjustment to Cancer (MAC) scale will measure a subjects ability to cope with diagnosis of recurrence and and assesses five cancer-specific coping strategies.
Changes in anxiety symptoms	12 weeks post completion of intervention	General Anxiety Disorder-7 (GAD-7) will assesses symptoms of anxiety

Trial Locations

Locations (1)

Mater Misericordiae University Hospital; 🇮🇪 Dublin, Ireland