Study protocol of ConquerFear-HK: a randomised controlled trial of a metacognition-based, manualised intervention for fear of cancer recurrence among Chinese cancer survivors
Introduction Fear of cancer recurrence (FCR) is a prevalent and frequently debilitating response to a cancer diagnosis, affecting a substantial proportion of cancer survivors. Approximately 30% of local Hong Kong Chinese cancer survivors in a recent survey reportedly experienced persistent high FCR...
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BMJ Publishing Group
2023-01-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/1/e065075.full |
| _version_ | 1827812196666572800 |
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| author | Joyce Chan Dacita Suen Ava Kwong Phyllis N Butow Chi Chung Foo Carmen Ng Richard Fielding Karen Kar Loen Chan Danielle Wing Lam Ng Catherine Tsang Amy Or Izy Wing Man Kong Julia Wei Chun Tang Wylie Wai Yee LI Amy Tien Yee Chang Simon Siu-Man Ng Miranda Chan Oi-Kwan Chun Wendy Wing Tak Lam |
| author_facet | Joyce Chan Dacita Suen Ava Kwong Phyllis N Butow Chi Chung Foo Carmen Ng Richard Fielding Karen Kar Loen Chan Danielle Wing Lam Ng Catherine Tsang Amy Or Izy Wing Man Kong Julia Wei Chun Tang Wylie Wai Yee LI Amy Tien Yee Chang Simon Siu-Man Ng Miranda Chan Oi-Kwan Chun Wendy Wing Tak Lam |
| author_sort | Joyce Chan |
| collection | DOAJ |
| description | Introduction Fear of cancer recurrence (FCR) is a prevalent and frequently debilitating response to a cancer diagnosis, affecting a substantial proportion of cancer survivors. Approximately 30% of local Hong Kong Chinese cancer survivors in a recent survey reportedly experienced persistent high FCR over the first-year post-surgery. This was associated with lower levels of psychological well-being and quality of life. A manualised intervention (ConquerFear) developed primarily based on the Self-Regulatory Executive Function Model and the Rational Frame Theory, has been found to reduce FCR effectively among Caucasian cancer survivors. The intervention now has been adapted to a Chinese context; ConquerFear-HK. The primary aim of this study is to evaluate its efficacy vs a standard-survivorship-care control (BasicCancerCare) in FCR improvement in a randomised control trial (RCT).Methods and analysis In this RCT, using the sealed envelope method, 174 eligible Chinese cancer survivors will be randomised to either the ConquerFear-HK or BasicCancerCare intervention. Both interventions include six sessions over 10 weeks, which will be delivered via face to face or online by trained therapists. The ConquerFear-HK intervention incorporates value classification, metacognitive therapy, attentional training, detached mindfulness and psychoeducation; BasicCancerCare includes relaxation training, dietary and physical activity consultations. Participants will be assessed at prior randomisation (baseline; T0), immediately postintervention (T1), 3 months (T2) and 6 months postintervention (T3) on the measures of FCR (Fear of Cancer Recurrence Inventory) as a primary outcome; metacognition (30-item Metacognitions Quesionnaire) and cognitive attentional syndrome (Cognitive-attentional Syndrome Questionnaire) as process outcomes; psychological distress (Hospital Anxiety and Depression Scale), cancer-related distress (Chinese Impact of Events Scale), quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire) and treatment satisfaction are secondary outcomes.Ethics and dissemination Ethics approval has been obtained from HKU/HA HKW Institutional Review Board (ref: UW19-183). The patients/participants provide their written informed consent to participate in this study. The study results will be disseminated through international peer-review publications and conference presentations.Trial registration number NCT04568226. |
| first_indexed | 2024-03-11T23:15:28Z |
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| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-11T23:15:28Z |
| publishDate | 2023-01-01 |
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| spelling | doaj.art-5ad89c8cf9b94515b5458104cdfb3ca22023-09-21T02:40:07ZengBMJ Publishing GroupBMJ Open2044-60552023-01-0113110.1136/bmjopen-2022-065075Study protocol of ConquerFear-HK: a randomised controlled trial of a metacognition-based, manualised intervention for fear of cancer recurrence among Chinese cancer survivorsJoyce Chan0Dacita Suen1Ava Kwong2Phyllis N Butow3Chi Chung Foo4Carmen Ng5Richard Fielding6Karen Kar Loen Chan7Danielle Wing Lam Ng8Catherine Tsang9Amy Or10Izy Wing Man Kong11Julia Wei Chun Tang12Wylie Wai Yee LI13Amy Tien Yee Chang14Simon Siu-Man Ng15Miranda Chan16Oi-Kwan Chun17Wendy Wing Tak Lam18HKU Jockey Club Institute of Cancer Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, Hong KongDepartment of Surgery, The University of Hong Kong, Hong Kong, Hong KongDepartment of Surgery, The University of Hong Kong, Hong Kong, Hong KongPsycho-Oncology Co-operative Research Group (PoCoG), School of Psychology, The University of Sydney, Sydney, New South Wales, AustraliaDepartment of Surgery, The University of Hong Kong, Hong Kong, Hong KongHKU Jockey Club Institute of Cancer Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, Hong KongCentre for Psycho-Oncological Research and Training, Division of Behavioural Sciences, School of Public Health, The University of Hong Kong, Hong Kong, Hong KongDepartment of Obstetric and Gynaecology, The University of Hong Kong, Hong Kong, Hong KongCentre for Psycho-Oncological Research and Training, Division of Behavioural Sciences, School of Public Health, The University of Hong Kong, Hong Kong, Hong KongHKU Jockey Club Institute of Cancer Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, Hong KongHKU Jockey Club Institute of Cancer Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, Hong KongHKU Jockey Club Institute of Cancer Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, Hong KongHKU Jockey Club Institute of Cancer Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, Hong KongHKU Jockey Club Institute of Cancer Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, Hong KongDepartment of Clinical Oncology, The University of Hong Kong, Hong Kong, Hong KongDepartment of Surgery, Faculty of Medicine, The Chinese University of Hong Kong, Hong KongDepartment of Surgery, Kwong Wah Hospital, Hong Kong Hospital Authority, Hong Kong, Hong KongDepartment of Surgery, Kwong Wah Hospital, Hong Kong Hospital Authority, Hong Kong, Hong KongCentre for Psycho-Oncological Research and Training, Division of Behavioural Sciences, School of Public Health, The University of Hong Kong, Hong Kong, Hong KongIntroduction Fear of cancer recurrence (FCR) is a prevalent and frequently debilitating response to a cancer diagnosis, affecting a substantial proportion of cancer survivors. Approximately 30% of local Hong Kong Chinese cancer survivors in a recent survey reportedly experienced persistent high FCR over the first-year post-surgery. This was associated with lower levels of psychological well-being and quality of life. A manualised intervention (ConquerFear) developed primarily based on the Self-Regulatory Executive Function Model and the Rational Frame Theory, has been found to reduce FCR effectively among Caucasian cancer survivors. The intervention now has been adapted to a Chinese context; ConquerFear-HK. The primary aim of this study is to evaluate its efficacy vs a standard-survivorship-care control (BasicCancerCare) in FCR improvement in a randomised control trial (RCT).Methods and analysis In this RCT, using the sealed envelope method, 174 eligible Chinese cancer survivors will be randomised to either the ConquerFear-HK or BasicCancerCare intervention. Both interventions include six sessions over 10 weeks, which will be delivered via face to face or online by trained therapists. The ConquerFear-HK intervention incorporates value classification, metacognitive therapy, attentional training, detached mindfulness and psychoeducation; BasicCancerCare includes relaxation training, dietary and physical activity consultations. Participants will be assessed at prior randomisation (baseline; T0), immediately postintervention (T1), 3 months (T2) and 6 months postintervention (T3) on the measures of FCR (Fear of Cancer Recurrence Inventory) as a primary outcome; metacognition (30-item Metacognitions Quesionnaire) and cognitive attentional syndrome (Cognitive-attentional Syndrome Questionnaire) as process outcomes; psychological distress (Hospital Anxiety and Depression Scale), cancer-related distress (Chinese Impact of Events Scale), quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire) and treatment satisfaction are secondary outcomes.Ethics and dissemination Ethics approval has been obtained from HKU/HA HKW Institutional Review Board (ref: UW19-183). The patients/participants provide their written informed consent to participate in this study. The study results will be disseminated through international peer-review publications and conference presentations.Trial registration number NCT04568226.https://bmjopen.bmj.com/content/13/1/e065075.full |
| spellingShingle | Joyce Chan Dacita Suen Ava Kwong Phyllis N Butow Chi Chung Foo Carmen Ng Richard Fielding Karen Kar Loen Chan Danielle Wing Lam Ng Catherine Tsang Amy Or Izy Wing Man Kong Julia Wei Chun Tang Wylie Wai Yee LI Amy Tien Yee Chang Simon Siu-Man Ng Miranda Chan Oi-Kwan Chun Wendy Wing Tak Lam Study protocol of ConquerFear-HK: a randomised controlled trial of a metacognition-based, manualised intervention for fear of cancer recurrence among Chinese cancer survivors BMJ Open |
| title | Study protocol of ConquerFear-HK: a randomised controlled trial of a metacognition-based, manualised intervention for fear of cancer recurrence among Chinese cancer survivors |
| title_full | Study protocol of ConquerFear-HK: a randomised controlled trial of a metacognition-based, manualised intervention for fear of cancer recurrence among Chinese cancer survivors |
| title_fullStr | Study protocol of ConquerFear-HK: a randomised controlled trial of a metacognition-based, manualised intervention for fear of cancer recurrence among Chinese cancer survivors |
| title_full_unstemmed | Study protocol of ConquerFear-HK: a randomised controlled trial of a metacognition-based, manualised intervention for fear of cancer recurrence among Chinese cancer survivors |
| title_short | Study protocol of ConquerFear-HK: a randomised controlled trial of a metacognition-based, manualised intervention for fear of cancer recurrence among Chinese cancer survivors |
| title_sort | study protocol of conquerfear hk a randomised controlled trial of a metacognition based manualised intervention for fear of cancer recurrence among chinese cancer survivors |
| url | https://bmjopen.bmj.com/content/13/1/e065075.full |
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