COMpassion FOcused Therapy and Breathing Pattern REtraining After Cancer Recurrence

Psychological Distress Clinical Trial

— COMFORT  

Official title:

A Randomised Control Trial Comparing Compassion Focused Therapy and Breathing Pattern Retraining With Treatment as Usual in Patients Diagnosed With Cancer Recurrence During COVID.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05518591
• Other study ID #: COV21LYN
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2022
• Est. completion date: June 2023

Study information

• Verified date: August 2022
• Source: University College Dublin
• Contact: Donal Brennan, PhD
• Phone: 01 716 4576
• Email: donal.brennan[@]ucd.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Recurrence
• Psychological Distress
• Recurrence

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Ireland	Mater Misericordiae University Hospital	Dublin

Sponsors (3)

Lead Sponsor	Collaborator
University College Dublin	Irish Cancer Society, Mater Misericordiae University Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Distress Score	The primary outcome is the patient's overall distress score, based on the Distress Thermometer (DT)	12 weeks post completion of intervention
Secondary	Changes in depressive symptoms	Patient Health Questionnaire-9 (PHQ-9) will assesses symptoms of depression	12 weeks post completion of intervention
Secondary	Changes in anxiety symptoms	General Anxiety Disorder-7 (GAD-7) will assesses symptoms of anxiety	12 weeks post completion of intervention
Secondary	Changes in traumatic distress	Impact of Event Scales- Revised (IES-R) will measure the amount of distress that a subject associates with a specific event.	12 weeks post completion of intervention
Secondary	Mental Adjustment to Cancer Recurrence	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.	12 weeks post completion of intervention