A Randomised Control Trial Comparing Compassion Focused Therapy and Breathing Pattern Retraining With Treatment as Usual in Patients Diagnosed With Cancer Recurrence During COVID.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Psychological Distress
- Sponsor
- University College Dublin
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Overall Distress Score
- Last Updated
- 3 years ago
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.
Investigators
Donal Brennan
Professor Donal Brennan
University College Dublin
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
Outcomes
Primary Outcomes
Overall Distress Score
Time Frame: 12 weeks post completion of intervention
The primary outcome is the patient's overall distress score, based on the Distress Thermometer (DT)
Secondary Outcomes
- Changes in depressive symptoms(12 weeks post completion of intervention)
- Changes in traumatic distress(12 weeks post completion of intervention)
- Mental Adjustment to Cancer Recurrence(12 weeks post completion of intervention)
- Changes in anxiety symptoms(12 weeks post completion of intervention)