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Table 2 Items from the World Health Organization Trial Registration Data Set

From: A web-based psycho-educational intervention (Fex-Can) targeting sexual dysfunction and fertility-related distress in young adults with cancer: study protocol of a randomized controlled trial

Data category Information
Primary registry and trial identifying number ISRCTN
ISRCTN36621459
Date of registration in primary registry 25 January 2016
Secondary identifying numbers https://doi.org/10.1186/ISRCTN36621459
Source(s) of monetary or material support Karolinska Institutet
Primary sponsor Cancer Research Foundations of Radiumhemmet
Swedish Cancer Society
Swedish Childhood Cancer Foundation
Vårdal Foundation
Swedish Research Council for Health, Working Life and Welfare
Swedish Research Council
Secondary sponsor(s) Doctoral School in Health Care Sciences at Karolinska Institutet
Contact for public queries Lena Wettergren, PhD [+46 (0)8524836 50] [lena.wettergren@ki.se]
Claudia Lampic, PhD [+ 46 (0)8524823 70] [claudia.lampic@ki.se]
Contact for scientific queries Lena Wettergren, PhD
Karolinska Institutet, Sweden
Public title Fex-Can – Fertility and sexuality following cancer
Scientific title Fex-Can – interventions to alleviate impact of cancer on fertility and sexuality among adolescents and young adults
Countries of recruitment Sweden
Health condition(s) or problem(s) studied Brain tumor, breast cancer, cervical cancer, lymphoma, ovarian cancer, and testicular cancer
Intervention(s) The Fex-Can intervention consists of two programs, The Fex-Can Sex and the Fex-Can Fertility, targeting sexual dysfunction and fertility-related distress respectively. They are web-based self-help programs delivered over a period of 12 weeks.
Key inclusion and exclusion criteria Ages eligible for study: 18–39 years at diagnosis
Sexes eligible for study: both
Accepts healthy volunteers: no
Inclusion criteria: adult patient (≥ 18 years) approximately 18 months after being diagnosed with cancer. Reporting sexual dysfunction or a high level of fertility-related distress.
Exclusion criteria: non-ability to read and/or understand Swedish language. Reporting poor health and/or significant cognitive impairment that hinder participation in the intervention.
Study type Interventional
Allocation: randomized
Intervention model: parallel assignment in blocks stratified by sex and diagnosis. The process will be performed separately for the arms of the RCT (Fex-Can Sex and Fex-Can Fertility)
Masking: not possible due to the nature of the intervention
Primary purpose: Efficacy trial
Date of first enrolment September 2017
Target sample size 256
Recruitment status Recruiting
Primary outcome(s) The primary outcome for the Fex-Can Sex program is the score (continuous measure) of the domain ‘Satisfaction with sex life’, a subscale of the Patient-Reported Outcomes Measurement Information System® Sexual Function and Satisfaction measure. The primary outcome of the Fex-Can Fertility will be the summary score of the Reproductive Concerns After Cancer (RCAC).
Key secondary outcomes Additional domains of sexual function (for participants in the Fex-Can Sex) and fertility-related knowledge (for participants in the Fex-Can Fertility). In addition, body image, health-related quality of life, anxiety and depression, self-efficacy (related to sexuality or fertility) measures will be used as secondary outcomes in both arms.