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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psychological Distress; Cancer Recurrence
• Intervention / Treatment: Behavioral: Compassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (BPR)

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Donal Brennan, PhD; Phone Number: 01 716 4576; Email: donal.brennan@ucd.ie
• Study Contact Backup: Name: Sinead Lynch, PhD; Phone Number: 087 803 9068; Email: SineadLynch@mater.ie

Study Locations

• Ireland
  • Dublin, Ireland
    • Recruiting
    • Mater Misericordiae University Hospital
    • Contact: Donal Brennan, PhD; Phone Number: 01 716 4576; Email: donal.brennan@ucd.ie
    • Principal Investigator: Donal Brennan, PhD
    • Sub-Investigator: Sinead Lynch, PhD
    • Sub-Investigator: Damien Lowry, PhD
    • Sub-Investigator: Yvonne O'Meara, Msc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in depressive symptoms	Patient Health Questionnaire-9 (PHQ-9) will assesses symptoms of depression	12 weeks post completion of intervention
Changes in anxiety symptoms	General Anxiety Disorder-7 (GAD-7) will assesses symptoms of anxiety	12 weeks post completion of intervention
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
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

Collaborators and Investigators

• Sponsor: University College Dublin
• Collaborators: Mater Misericordiae University Hospital; Irish Cancer Society
• Investigators: Principal Investigator: Sinead Lynch, PhD, MMUH

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: COV21LYN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No