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Study protocol for ...
Study protocol for the Fex-Can Childhood project An observational study and a randomized controlled trial focusing on sexual dysfunction and fertility-related distress in young adult survivors of childhood cancer
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- Ljungman, Lisa, 1981- (author)
- Karolinska Institutet,Uppsala universitet,Reproduktiv hälsa,Karolinska Inst, Dept Womens & Childrens Hlth, Stockholm, Sweden.
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- Anandavadivelan, Poorna (author)
- Karolinska Inst, Dept Womens & Childrens Hlth, Stockholm, Sweden.
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- Jahnukainen, Kirsi (author)
- Univ Helsinki, Div Haematol Oncol & Stem Cell Transplantat, Childrens Hosp, Helsinki Univ Cent Hosp, Helsinki, Finland.;Karolinska Inst, NORDFERTIL Res Lab Stockholm, Childhood Canc Res Unit, Dept Womens & Childrens Hlth, Stockholm, Sweden.;Univ Hosp, Stockholm, Sweden.
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- Lampic, Claudia, 1964- (author)
- Karolinska Institutet,Uppsala universitet,Institutionen för folkhälso- och vårdvetenskap,Karolinska Inst, Dept Womens & Childrens Hlth, Stockholm, Sweden,Department of Women’s and Children’s Health, Karolinska Institutet, Stockholm, Sweden; Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden
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- Wettergren, Lena (author)
- Karolinska Inst, Dept Womens & Childrens Hlth, Stockholm, Sweden.
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(creator_code:org_t)
- Ovid Technologies (Wolters Kluwer Health), 2020
- 2020
- English.
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In: Medicine. - : Ovid Technologies (Wolters Kluwer Health). - 0025-7974 .- 1536-5964. ; 99:28
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Abstract
Subject headings
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- Background: This study protocol describes the Fex-Can Childhood project, comprising two studies: The Fex-Can Childhood observational study (OS) and the Fex-Can Childhood randomized controlled trial (RCT). The Fex-Can Childhood OS aims to determine the prevalence and predictors of sexual dysfunction and fertility-related distress in young adult childhood cancer survivors (aged 19-40) compared to an age matched comparison group; the Fex-Can Childhood RCT will evaluate the effect of a web-based psycho-educational intervention (Fex-Can intervention) on sexual dysfunction and fertility-related distress. Methods: The Fex-Can Childhood OS will have a population-based cross-sectional design. All individuals treated for childhood cancer in Sweden at the age of 0 to 17 years (current age 19-40) will be identified through the National Quality Registry for Childhood Cancer. Established self-reported instruments will be used to measure sexual function, fertility-related distress, body image, anxiety and depression, and health-related quality of life. Self-efficacy related to sexual function and fertility, and fertility-related knowledge, will be assessed by study-specific measures. Clinical variables will be collected from the registry. Results will be compared to an age-matched comparison group from the general population. Participants in the Fex-Can Childhood OS who report a high level of sexual dysfunction and/or fertility-related distress will be invited to participate in the RCT. The Fex-Can intervention comprises two programs: The Fex-Can Sex and the Fex-Can Fertility targeting sexual dysfunction and fertility-related distress, respectively. The control condition will be a wait-list. Sexual function and fertility-related distress will be the primary outcomes. The secondary outcomes include body image, anxiety and depression, health-related quality of life and self-efficacy related to sexual function and fertility. Post- and follow-up assessments will be conducted directly after end of intervention (primary end point), at 3 months and 6 months after end of intervention. Additionally, a process-evaluation including study-specific items and a qualitative interview will be conducted. Discussion: The Fex-Can Childhood project will advance knowledge in the areas of sexual function and fertility-related distress among young adult survivors of childhood cancer. If the Fex-Can intervention proves to be efficacious, steps will be taken to implement it in the follow-up care provided to this population.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Reproduktionsmedicin och gynekologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Obstetrics, Gynaecology and Reproductive Medicine (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Omvårdnad (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Nursing (hsv//eng)
Keyword
- childhood cancer
- fertility-related distress
- intervention
- observational study
- randomized controlled trial
- sexual function
- survivors
- young adults
Publication and Content Type
- ref (subject category)
- art (subject category)
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