COMpassion FOcused Therapy and Breathing Pattern REtraining After Cancer Recurrence (COMFORT)
Primary Purpose
Psychological Distress, Cancer Recurrence
Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Compassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (BPR)
Sponsored by
About this trial
This is an interventional supportive care trial for Psychological Distress
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
Sites / Locations
- Mater Misericordiae University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CFT & BPR
Treatment As Usual
Arm 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.
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.
Outcomes
Primary Outcome Measures
Overall Distress Score
The primary outcome is the patient's overall distress score, based on the Distress Thermometer (DT)
Secondary Outcome Measures
Changes in depressive symptoms
Patient Health Questionnaire-9 (PHQ-9) will assesses symptoms of depression
Changes in anxiety symptoms
General Anxiety Disorder-7 (GAD-7) will assesses symptoms of anxiety
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.
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.
Full Information
NCT ID
NCT05518591
First Posted
August 24, 2022
Last Updated
August 24, 2022
Sponsor
University College Dublin
Collaborators
Mater Misericordiae University Hospital, Irish Cancer Society
1. Study Identification
Unique Protocol Identification Number
NCT05518591
Brief Title
COMpassion FOcused Therapy and Breathing Pattern REtraining After Cancer Recurrence
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Dublin
Collaborators
Mater Misericordiae University Hospital, Irish Cancer Society
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Distress, Cancer Recurrence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CFT & BPR
Arm Type
Experimental
Arm 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.
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Compassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (BPR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Distress Score
Description
The primary outcome is the patient's overall distress score, based on the Distress Thermometer (DT)
Time Frame
12 weeks post completion of intervention
Secondary Outcome Measure Information:
Title
Changes in depressive symptoms
Description
Patient Health Questionnaire-9 (PHQ-9) will assesses symptoms of depression
Time Frame
12 weeks post completion of intervention
Title
Changes in anxiety symptoms
Description
General Anxiety Disorder-7 (GAD-7) will assesses symptoms of anxiety
Time Frame
12 weeks post completion of intervention
Title
Changes in traumatic distress
Description
Impact of Event Scales- Revised (IES-R) will measure the amount of distress that a subject associates with a specific event.
Time Frame
12 weeks post completion of intervention
Title
Mental Adjustment to Cancer Recurrence
Description
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.
Time Frame
12 weeks post completion of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donal Brennan, PhD
Phone
01 716 4576
Email
donal.brennan@ucd.ie
First Name & Middle Initial & Last Name or Official Title & Degree
Sinead Lynch, PhD
Phone
087 803 9068
Email
SineadLynch@mater.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sinead Lynch, PhD
Organizational Affiliation
MMUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mater Misericordiae University Hospital
City
Dublin
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donal Brennan, PhD
Phone
01 716 4576
Email
donal.brennan@ucd.ie
First Name & Middle Initial & Last Name & Degree
Donal Brennan, PhD
First Name & Middle Initial & Last Name & Degree
Sinead Lynch, PhD
First Name & Middle Initial & Last Name & Degree
Damien Lowry, PhD
First Name & Middle Initial & Last Name & Degree
Yvonne O'Meara, Msc
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COMpassion FOcused Therapy and Breathing Pattern REtraining After Cancer Recurrence
We'll reach out to this number within 24 hrs