COMpassion FOcused Therapy and Breathing Pattern REtraining After Cancer Recurrence

Study Overview
=================
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.

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.

Conditions
-----------------
Psychological Distress, Cancer Recurrence

Intervention / Treatment
-----------------
* Behavioral: Compassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (BPR)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CFT & BPR<br>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)<br>* 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.<br>|
| No Intervention: Treatment As Usual<br>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 |