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