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Trial Title:
COMpassion FOcused Therapy and Breathing Pattern REtraining After Cancer Recurrence
NCT ID:
NCT05518591
Condition:
Psychological Distress
Cancer Recurrence
Conditions: Official terms:
Recurrence
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Compassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (BPR)
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.
Arm group label:
CFT & BPR
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mater Misericordiae University Hospital
Address:
City:
Dublin
Country:
Ireland
Status:
Recruiting
Contact:
Last name:
Donal Brennan, PhD
Phone:
01 716 4576
Email:
donal.brennan@ucd.ie
Investigator:
Last name:
Donal Brennan, PhD
Email:
Principal Investigator
Investigator:
Last name:
Sinead Lynch, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Damien Lowry, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Yvonne O'Meara, Msc
Email:
Sub-Investigator
Start date:
March 25, 2022
Completion date:
June 2023
Lead sponsor:
Agency:
University College Dublin
Agency class:
Other
Collaborator:
Agency:
Mater Misericordiae University Hospital
Agency class:
Other
Collaborator:
Agency:
Irish Cancer Society
Agency class:
Other
Source:
University College Dublin
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05518591
