Fertility Preservation in Men Affected by Cancer

NCT03876366 | Completed

• 1 other identifier: 2017-02069; sp19Tschudin
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cancer

Keywords

cancer patients; male cancer patients; Decision Aid (DA); online Decision Aid tool

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• male cancer patients needs regarding decision-making about FP

  Phase 1 online survey at baseline

• male cancer patients expectation with regard to an online DA tool about FP

  Phase 1 online survey at baseline

• male cancer patients needs regarding decision-making about FP

  Phase 2 focus group meeting (approx. 2 to 4 weeks after baseline)

• male cancer patients expectation with regard to an online DA tool about FP

  Phase 2 focus group meeting (approx. 2 to 4 weeks after baseline)

Interventions

online survey OTHER

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 OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cancer patients who are/were possible candidates for FP (patients with fertility compromising cancer treatment) will be invited to participate. Eligible patients will be approached by their former or current treating oncologist, urologist or specialist in reproductive medicine.

You may qualify if:

• German speaking
• Cancer diagnosis within the last 10 years (minimum age at diagnosis 13 years)
• Cancer therapy that was expected to impair fertility

You may not qualify if:

• Prepubertal at diagnosis

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Krebsforschung Schweiz, Bern, Switzerland: collaborator

Study Sites (1)

Frauenklinik University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Sibil Tschudin, PD Dr. med

  Frauenklinik Universitätsspital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 15, 2019
• Study Start: January 2, 2018
• Primary Completion: February 13, 2020
• Study Completion: February 13, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

CH (1)