Lifestyle and Empowerment Techniques in Survivorship of Gynaecologic Oncology (LETSGO study): a study protocol for a multicentre longitudinal interventional study using mobile health technology and biobanking
Introduction The number of gynaecological cancer survivors is increasing and there is a need for a more sustainable model of follow-up care. Today’s follow-up model is time-consuming and patients have reported unmet needs regarding information about their cancer and strategies for managing the conse...
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| Format: | Article |
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BMJ Publishing Group
2021-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/7/e050930.full |
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| author | Milada Cvancarova Småstuen Ingvild Vistad Torbjørn Wisløff Kristina Lindemann Lonneke V van de Poll-Franse Mette Skorstad Sveinung Berntsen Ingrid Demmelmaier |
| author_facet | Milada Cvancarova Småstuen Ingvild Vistad Torbjørn Wisløff Kristina Lindemann Lonneke V van de Poll-Franse Mette Skorstad Sveinung Berntsen Ingrid Demmelmaier |
| author_sort | Milada Cvancarova Småstuen |
| collection | DOAJ |
| description | Introduction The number of gynaecological cancer survivors is increasing and there is a need for a more sustainable model of follow-up care. Today’s follow-up model is time-consuming and patients have reported unmet needs regarding information about their cancer and strategies for managing the consequences of treatment. The main aim of this study is to assess health-related empowerment—in terms of patient education, psychosocial support, and promotion of physical activity—in a new follow-up model by comparing it to standard follow-up in a quasi-randomised study involving intervention hospitals and control hospitals.Methods and analysis At the intervention hospitals, patients will be stratified by risk of recurrence and late effects to either 1 or 3 years’ follow-up. Nurses will replace doctors in half of the follow-up visits and focus in particular on patient education, self-management and physical activity. They will provide patients with information and guide them in goal setting and action planning. These measures will be reinforced by a smartphone application for monitoring symptoms and promoting physical activity. At the control hospitals, patients will be included in the standard follow-up programme. All patients will be asked to complete questionnaires at baseline and after 3, 6, 12, 24 and 36 months. Blood samples will be collected for biobanking at 3, 12 and 36 months. The primary outcome is health-related empowerment. Secondary outcomes include health-related quality of life, adherence to physical activity recommendations, time to recurrence, healthcare costs and changes in biomarkers. Changes in these outcomes will be analysed using generalised linear mixed models for repeated measures. Type of hospital (intervention or control), time (measurement point), and possible confounders will be included as fixed factors.Ethics and dissemination The study is approved by the Regional Committee for Medical Research Ethics (2019/11093). Dissemination of findings will occur at the local, national and international levels.Trial registration number NCT04122235. |
| format | Article |
| id | doaj-art-44f783e0698e4c3683dc6dfc056f00a4 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-44f783e0698e4c3683dc6dfc056f00a42025-08-20T01:47:24ZengBMJ Publishing GroupBMJ Open2044-60552021-07-0111710.1136/bmjopen-2021-050930Lifestyle and Empowerment Techniques in Survivorship of Gynaecologic Oncology (LETSGO study): a study protocol for a multicentre longitudinal interventional study using mobile health technology and biobankingMilada Cvancarova Småstuen0Ingvild Vistad1Torbjørn Wisløff2Kristina Lindemann3Lonneke V van de Poll-Franse4Mette Skorstad5Sveinung Berntsen6Ingrid Demmelmaier7Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway1Sørlandet Hospital HF, Kristiansand S, Norway5 Department of Community Medicine, UiT The Arctic University of Norway, Tromso, NorwayDepartment of Gynecological Oncology, Division of Cancer Medicine, Oslo University Hospital, Oslo, NorwayDivision of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, The Netherlands1 Department of Gynaecology and Obstetrics, Sorlandet Hospital Kristiansand, Kristiansand, NorwayDepartment of Sport Science and Physical Education, University of Agder, Kristiansand, NorwayDepartment of Public Health and Caring Sciences, Lifestyle and Rehabilitation in Long-term Illness, Uppsala Universitet, Uppsala, SwedenIntroduction The number of gynaecological cancer survivors is increasing and there is a need for a more sustainable model of follow-up care. Today’s follow-up model is time-consuming and patients have reported unmet needs regarding information about their cancer and strategies for managing the consequences of treatment. The main aim of this study is to assess health-related empowerment—in terms of patient education, psychosocial support, and promotion of physical activity—in a new follow-up model by comparing it to standard follow-up in a quasi-randomised study involving intervention hospitals and control hospitals.Methods and analysis At the intervention hospitals, patients will be stratified by risk of recurrence and late effects to either 1 or 3 years’ follow-up. Nurses will replace doctors in half of the follow-up visits and focus in particular on patient education, self-management and physical activity. They will provide patients with information and guide them in goal setting and action planning. These measures will be reinforced by a smartphone application for monitoring symptoms and promoting physical activity. At the control hospitals, patients will be included in the standard follow-up programme. All patients will be asked to complete questionnaires at baseline and after 3, 6, 12, 24 and 36 months. Blood samples will be collected for biobanking at 3, 12 and 36 months. The primary outcome is health-related empowerment. Secondary outcomes include health-related quality of life, adherence to physical activity recommendations, time to recurrence, healthcare costs and changes in biomarkers. Changes in these outcomes will be analysed using generalised linear mixed models for repeated measures. Type of hospital (intervention or control), time (measurement point), and possible confounders will be included as fixed factors.Ethics and dissemination The study is approved by the Regional Committee for Medical Research Ethics (2019/11093). Dissemination of findings will occur at the local, national and international levels.Trial registration number NCT04122235.https://bmjopen.bmj.com/content/11/7/e050930.full |
| spellingShingle | Milada Cvancarova Småstuen Ingvild Vistad Torbjørn Wisløff Kristina Lindemann Lonneke V van de Poll-Franse Mette Skorstad Sveinung Berntsen Ingrid Demmelmaier Lifestyle and Empowerment Techniques in Survivorship of Gynaecologic Oncology (LETSGO study): a study protocol for a multicentre longitudinal interventional study using mobile health technology and biobanking BMJ Open |
| title | Lifestyle and Empowerment Techniques in Survivorship of Gynaecologic Oncology (LETSGO study): a study protocol for a multicentre longitudinal interventional study using mobile health technology and biobanking |
| title_full | Lifestyle and Empowerment Techniques in Survivorship of Gynaecologic Oncology (LETSGO study): a study protocol for a multicentre longitudinal interventional study using mobile health technology and biobanking |
| title_fullStr | Lifestyle and Empowerment Techniques in Survivorship of Gynaecologic Oncology (LETSGO study): a study protocol for a multicentre longitudinal interventional study using mobile health technology and biobanking |
| title_full_unstemmed | Lifestyle and Empowerment Techniques in Survivorship of Gynaecologic Oncology (LETSGO study): a study protocol for a multicentre longitudinal interventional study using mobile health technology and biobanking |
| title_short | Lifestyle and Empowerment Techniques in Survivorship of Gynaecologic Oncology (LETSGO study): a study protocol for a multicentre longitudinal interventional study using mobile health technology and biobanking |
| title_sort | lifestyle and empowerment techniques in survivorship of gynaecologic oncology letsgo study a study protocol for a multicentre longitudinal interventional study using mobile health technology and biobanking |
| url | https://bmjopen.bmj.com/content/11/7/e050930.full |
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