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Completed

NCT Number: NCT03876366

Fertility Preservation in Men Affected by Cancer

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).

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Frauenklinik University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. male cancer patients level of information with regard to FP

    Time frame: 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

    Time frame: 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 outcomes

  1. male cancer patients needs regarding decision-making about FP

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Krebsforschung Schweiz, Bern, Switzerland

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 15, 2019
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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