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Study protocol for a feasibility study of an internet-administered, guided, CBT-based, self-help intervention (ENGAGE) for parents of children previously treated for cancer
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Research group (Dept. of women´s and children´s health), Clinical Psychology in Healthcare.ORCID iD: 0000-0001-5062-6798
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Research group (Dept. of women´s and children´s health), Clinical Psychology in Healthcare.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Research group (Dept. of women´s and children´s health), Clinical Psychology in Healthcare.ORCID iD: 0000-0002-7237-4429
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Research group (Dept. of women´s and children´s health), Neuropediatrics/Paediatric oncology.
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2018 (English)In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 8, no 6, article id e023708Article in journal (Refereed) Published
Abstract [en]

INTRODUCTION: A subgroup of parents of children previously treated for cancer report long-term psychological distress after end of treatment. However, needs for psychological support are commonly unmet and there is a lack of evidence-based treatments tailored to the specific needs of this population. An internet-administered, guided, cognitive-behavioural therapy-based, self-help intervention (ENGAGE) for parents of children previously treated for cancer may provide a solution. The aim is to examine the feasibility and acceptability of the intervention ENGAGE and the study procedures for a future controlled trial.

METHODS AND ANALYSIS: The study has an uncontrolled within-group design with an embedded qualitative and quantitative process evaluation. Potential participants are parents of children previously treated for cancer, living in Sweden, recruited via their child's personal identification number (via the Swedish Childhood Cancer Registry and the Swedish Tax Agency). Parents are invited randomly with information packs sent to home addresses. Further interest in participating can be registered via information on relevant websites. The study aims to recruit 50 parents who will receive the intervention ENGAGE which is designed to be delivered over a 10-week period, and comprises one introductory chapter followed by up to 10 intervention modules addressing key concerns identified for the population. Consistent with feasibility study objectives, primary outcomes relate to recruitment, attrition, data collection, study resources, intervention delivery and acceptability. Clinical outcomes (post-traumatic stress, depression, anxiety, fear of cancer recurrence, psychological inflexibility and experiential avoidance, depressed inactivity, fatigue, quality of life and self-compassion) will be measured at baseline, post-treatment (12 weeks) and 6-month follow-up.

ETHICS AND DISSEMINATION: The Regional Ethical Review Board in Uppsala, Sweden has granted approval for the study (Dnr: 2017/527). Results will be disseminated to relevant healthcare and patient communities, in peer-reviewed and popular science journals, and at scientific and clinical conferences.

TRIAL REGISTRATION NUMBER: ISRCTN57233429; Pre-results.

Place, publisher, year, edition, pages
2018. Vol. 8, no 6, article id e023708
Keywords [en]
anxiety, clinical trial, depression, eHealth, parents
National Category
Psychology Cancer and Oncology
Identifiers
URN: urn:nbn:se:uu:diva-355488DOI: 10.1136/bmjopen-2018-023708ISI: 000435567900114PubMedID: 29903802OAI: oai:DiVA.org:uu-355488DiVA, id: diva2:1229239
Funder
Swedish Research Council, K2015-99X-20836-08-4Swedish Cancer Society, 170709Swedish Childhood Cancer Foundation, PR2017-0005Available from: 2018-06-29 Created: 2018-06-29 Last updated: 2018-09-20Bibliographically approved

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Woodford, JoanneWikman, AnnaCernvall, MartinLjungman, GustafGrönqvist, Helenavon Essen, Louise

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