Fertility Preservation in Men Affected by Cancer

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Completed
• CT.gov ID: NCT03876366
• Collaborator: Krebsforschung Schweiz, Bern, Switzerland (Other)
• Enrollment: 71
• Location: 1
• Actual Duration (Months): 25.4
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cancer	Other: online survey; Other: focus group meeting

Study Design

• Study Type: Observational
• Actual Enrollment: 71 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Fertility Preservation in Men Affected by Cancer: Assessment of Patients' Needs and Development of an Online Decision-aid
• Actual Study Start Date: Jan 2, 2018
• Actual Primary Completion Date: Feb 13, 2020
• Actual Study Completion Date: Feb 13, 2020

Outcome Measures

Primary Outcome Measures

1. male cancer patients level of information with regard to FP [Phase 1 online survey at baseline]

   Phase 1: exploratory online survey inquiring male cancer patients level of information with regard to FP

2. male cancer patients level of information with regard to FP [Phase 2 focus group meeting (approx. 2 to 4 weeks after baseline)]

   Phase 2: interview (strictly exploratory) in focus groups collecting data on male cancer patients level of information with regard to FP

Secondary Outcome Measures

1. male cancer patients needs regarding decision-making about FP [Phase 1 online survey at baseline]

   exploratory online survey inquiring which kind of support regarding decision-making about FP do male cancer patients consider helpful

2. male cancer patients expectation with regard to an online DA tool about FP [Phase 1 online survey at baseline]

   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

3. male cancer patients needs regarding decision-making about FP [Phase 2 focus group meeting (approx. 2 to 4 weeks after baseline)]

   Phase 2: interview (strictly exploratory) in focus groups evaluating which kind of support regarding decision-making about FP male cancer patients consider helpful

4. 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)]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Frauenklinik University Hospital Basel	Basel		Switzerland	4031

Sponsors and Collaborators

• University Hospital, Basel, Switzerland
• Krebsforschung Schweiz, Bern, Switzerland

Investigators

• Principal Investigator: Sibil Tschudin, PD Dr. med, Frauenklinik Universitätsspital Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT03876366
• Other Study ID Numbers: 2017-02069; sp19Tschudin
• First Posted: Mar 15, 2019
• Last Update Posted: Mar 25, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Basel, Switzerland: cancer patients; male cancer patients; Decision Aid (DA); online Decision Aid tool

Study Results

No Results Posted as of Mar 25, 2020