Administrative information
Title {1} | The COMFORT Trial: A randomised control trial comparing group-based COMpassion FOcused Therapy and breathing pattern ReTraining with Treatment As Usual on the psychological functioning of patients diagnosed with cancer recurrence during COVID. |
Trial registration {2a and 2b}. | This trial was pre-registered on ClinicalTrials.gov on 25 August 2022. Identifier number: NCT05518591. All items from the World Health Organisation Trial Registration Data set have been included. https://clinicaltrials.gov/ct2/show/ NCT05518591 |
Protocol version {3} | Protocol version 1: August, 2022 |
Funding {4} | This trial is being funded by the Irish Cancer Society (Grant code: COV21LYN). University College Dublin is the Host Institution/Sponsor and the Mater Misericordiae University Hospital is the clinical site. |
Author details {5a} | (1). Dr Sinead Lynch*, Senior Counselling Psychologist, Depts. of Psychology and Psycho-Oncology, Mater Misericordiae University Hospital. SineadLynch@mater.ie (Correspondence). *Co-first author (2). Dr Damien Lowry*, Chartered Senior Counselling Psychologist, Depts. of Psychology and Pain Medicine, Mater Misericordiae University Hospital, Dublin, Ireland; dlowry@mater.ie (Correspondence). *Co-first author (3). Ms Clodagh Finnerty, Research Assistant, COMFORT trial, University College Dublin. (4). Yvonne O’Meara, Women’s Cancer Survivorship Research Coordinator, School of Medicine, University College Dublin. (5). Prof Donal Brennan, Consultant Gynaecological and Medical Oncologist and Professor of Gynaecological Oncology and Medical Oncology, Mater Misericordiae University Hospital and School of Medicine, University College Dublin. |
Name and contact information for the trial sponsor {5b} | The Sponsor for this Study is The School of Medicine, University College Dublin, Ireland. Contact Person: Prof Donal Brennan, Professor of Gynaecological Oncology and Medical Oncology, Email:school.medicine@ucd.ie, Office 00 353 1 716 6603 |
Role of sponsor {5c} | This is a hypothesis-driven, investigator-initiated trial. Therefore, the funders played no role in the design of the study, data collection, analysis, interpretation of data, or in the writing of the manuscript, other than by way of reviewing the grant application. |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions and outcomes
Study setting {9}
Eligibility criteria {10}
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Adults aged 18 or older
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Pre-existing cancer diagnosis
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Diagnosis of cancer recurrence during COVID-19 (March 2020 onwards) including a documented recurrent, progressive or metastatic cancer
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Living in Ireland
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English speaking/fluency
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Access to Web/tech support
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A score <4 on the Distress Thermometer
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Patient non-consent
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Severe mental illness (e.g. schizophrenia, personality disorder and/or active severe illness)
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Known or suspected drug or alcohol abuse problems within the past 3 months.
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Inability to follow the study procedures, e.g. dementia or non-fluency of English
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Technological inability
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Life expectancy <3 months
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
The intervention
Intervention group: compassion-focussed therapy and breathing pattern retraining
Session | Summary of sessions |
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1 | Part 1: Breathing pattern retraining education, breathing assessment, simple breath work. Physiotherapy demo in video and simple breath work Part 2: Understanding compassion, CFT explained, model and intervention review; why we need compassion, our tricky brains and defining emotions such as shame, fear and loneliness; Monkey Mind meditation, just noticing our busy minds |
2 | Part 1: Motivation and our complex brains; understanding motives and emotions—breaking through fear and blocks Part 2: How our thoughts and images affect our minds and brains; breathing patterns—the mind–body connection. Breathing pattern retraining education—exploring the physiotherapy-led exercises |
3 | Part 1: Compassionate thinking; the 3 components of self-compassion: mindfulness, common humanity and kindness. How this links with soothing breathing Part 2: Dysfunctional breathing and stress; breathing awareness and breathing practices such as tender self-compassion break and affectionate breathing |
4 | Part 1: Compassionate mind training through imagery—creating your compassionate self Part 2: Creating your compassionate self; breathing pattern retraining techniques and practice combining compassionate imagery |
5 | Part 1: From self-criticism and loneliness/fear to self-compassion. Distancing and wise observing; breaking identification with one’s thoughts Part 2: Loving kindness meditation; visualising ideal compassionate self; using our compassionate self to work on self-criticism |
6 | Part 1: Compassionate thinking, attention, behaviour and feeling; cultivating kindness; letter to self and final session Part 2: Looking forward—sustaining our compassionate mind; what I have learned and achieved? Reading letter-to-self using the breath |
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Primary outcome
Secondary outcomes
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The Patient Health Questionnaire (PHQ-9) total score [time frame: 3 months post-group programme]oThe PHQ-9 is a clinically validated, nine-item instrument for screening, monitoring and evaluating symptoms of depression [24]. It incorporates the Diagnostic and Statistics Manual for Mental Disorders, fourth edition (DSM-IV), diagnostic criteria into a brief self-report tool and asks how often a person has ‘been bothered’ by any of the itemised problems in the preceding 2 weeks. Scores range from 0 to 27 and scores ≥ 10 had a sensitivity of 88% and a specificity of 88% for major depression. Scores of 5, 10, 15 and 20 represent mild, moderate, moderately severe and severe depression, respectively.
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The Generalised Anxiety Disorder Questionnaire (GAD-7) score [time frame: 3 months post-group programme]oThe GAD-7 is an easy-to-use, self-administered screening instrument comprising seven questions. Scores range from 0 to 21, with scores ≥ 10 achieving a sensitivity of 89% and a specificity of 82% for generalised anxiety [Spitzer et al., 2006]. It also enjoys modest effectiveness at screening for other anxiety disorders [25]. Scores of 5, 10 and 15 are the cut-off thresholds for mild, moderate and severe anxiety, respectively.
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The Impact of Event Scale-Revised (IES-R) score [time frame: 3 months post-group programme]oThe IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events [26]. Items correspond to 14 of the 17 DSM-IV symptoms of post-traumatic stress disorder (PTSD). Respondents are asked to name a specific traumatic event with subsequent answers reflecting how distressed or bothered they have felt by each item listed, over the previous 7 days. The instrument yields a score ranging from 0 to 88 along with subscale scores that relate to intrusive phenomena, avoidance and hyperarousal. A cut-off score of ≥ 34 has been suggested for the IER-R as a threshold for probable PTSD, as it has been found to provide good values on sensitivity (86–89%) and specificity (80–81%) in two samples of survivors of war [27].
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The Mini-Mental Adjustment to Cancer Scale (mini-MAC) score [time frame: 3 months post-group programme]oThe Mini-MAC is a 29-item self-rating questionnaire which was designed to provide a method of assessing specific responses to cancer along the following dimensions: ‘fighting spirit’, ‘helpless/hopeless’, ‘anxious preoccupation’, ‘fatalism’ and ‘avoidance’ [28]. There are published clinical cut-off scores for the dimensions of Summary Negative Adjustment (SNA) and Summary Positive Adjustment (SPA) when scores on thesis scales exceed 36 or fall below 47, respectively [29].
Participant timeline {13}
Outcomes | Instrument | Enrolment Baseline t(0) | 6-Wk group intervention | Post-group outcomes t(1) | 3-month post-group t(2) |
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Primary outcome | |||||
Distress Thermometer | DT | X | X | X | |
Secondary outcomes | |||||
Depressed mood | PHQ-9 | X | X | X | |
Anxiety | GAD-7 | X | X | X | |
Traumatic distress | IES-R | X | X | X | |
Mini-Mental adjustment to cancer | Mini-MAC | X | X | X | |
Other variables | |||||
Patient demographics | X |