Fertility Preservation in Men Affected by Cancer

Cancer Clinical Trial

Official title:

Fertility Preservation in Men Affected by Cancer: Assessment of Patients' Needs and Development of an Online Decision-aid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03876366
• Other study ID #: 2017-02069; sp19Tschudin
• Status: Completed
• Start date: January 2, 2018
• Est. completion date: February 13, 2020

Study information

• Verified date: March 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a single center cross-sectional retrospective study with a quantitative and qualitative approach (phase 1 and 2). In phase 1 an online survey will be realized and targets male cancer survivors. Phase 2 will take a qualitative approach, in which information about patient's experiences, needs and helpful support will be collected by establishing focus groups of cancer patients who had been diagnosed during the reproductive age.

In the end, the results of this study will be integrated into the development of an online support tool concerning Fertility Preservation (FP).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 13, 2020
• Est. primary completion date: February 13, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• German speaking

• Cancer diagnosis within the last 10 years (minimum age at diagnosis 13 years)

• Cancer therapy that was expected to impair fertility

Exclusion Criteria:

• Prepubertal at diagnosis

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• online survey
Part 1: online survey (quantitative) with questions on basic socio-demographic data, medical data and family characteristics (e.g. age, ethnicity, education) and information about FP.
• focus group meeting
Part 2: At the end of the online survey, participants are invited to attend one of the consecutively performed focus groups conducted according to standardized focus group methodology and moderated by a clinical psychologist and a specialist in reproductive medicine.

Locations

Country	Name	City	State
Switzerland	Frauenklinik University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Krebsforschung Schweiz, Bern, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	male cancer patients level of information with regard to FP	Phase 1: exploratory online survey inquiring male cancer patients level of information with regard to FP	Phase 1 online survey at baseline
Primary	male cancer patients level of information with regard to FP	Phase 2: interview (strictly exploratory) in focus groups collecting data on male cancer patients level of information with regard to FP	Phase 2 focus group meeting (approx. 2 to 4 weeks after baseline)
Secondary	male cancer patients needs regarding decision-making about FP	exploratory online survey inquiring which kind of support regarding decision-making about FP do male cancer patients consider helpful	Phase 1 online survey at baseline
Secondary	male cancer patients expectation with regard to an online DA tool about FP	exploratory online survey inquiring how an online Decision Aid (DA) tool about FP has to be designed in order to be helpful for male cancer patients	Phase 1 online survey at baseline
Secondary	male cancer patients needs regarding decision-making about FP	Phase 2: interview (strictly exploratory) in focus groups evaluating which kind of support regarding decision-making about FP male cancer patients consider helpful	Phase 2 focus group meeting (approx. 2 to 4 weeks after baseline)
Secondary	male cancer patients expectation with regard to an online DA tool about FP	Phase 2: interview (strictly exploratory) in focus groups evaluating how an online DA tool about FP has to be designed in order to be helpful for male cancer patients	Phase 2 focus group meeting (approx. 2 to 4 weeks after baseline)