Fertility Preservation in Men Affected by Cancer

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

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).

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: online survey; Other: focus group meeting

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Frauenklinik University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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)
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)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Krebsforschung Schweiz, Bern, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): February 13, 2020
• Study Completion (Actual): February 13, 2020

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: cancer patients; male cancer patients; Decision Aid (DA); online Decision Aid tool
• Other Study ID Numbers: 2017-02069; sp19Tschudin

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No