Clinical trial NCT05518591: COMpassion FOcused Therapy and Breathing Pattern REtraining After Cancer Recurrence
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
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological Distress
Cancer Recurrence
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: Mater Misericordiae University Hospital
name: Irish Cancer Society
First posted: 2022-08-26
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Overall Distress Score
timeFrame: 12 weeks post completion of intervention
Secondary outcomes:
measure: Changes in depressive symptoms
timeFrame: 12 weeks post completion of intervention
measure: Changes in anxiety symptoms
timeFrame: 12 weeks post completion of intervention
measure: Changes in traumatic distress
timeFrame: 12 weeks post completion of intervention
measure: Mental Adjustment to Cancer Recurrence
timeFrame: 12 weeks post completion of intervention
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
Study officials:
affiliation: MMUH
name: Sinead Lynch, PhD
role: PRINCIPAL_INVESTIGATOR
References: