CancerNCT03876366
Fertility Preservation in Men Affected by Cancer
An observational study of Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cancer
- What is being tested?
- online survey and focus group meeting
- How many people
- 71 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Jan 2018to 13 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- German speaking
- Cancer diagnosis within the last 10 years (minimum age at diagnosis 13 years)
- Cancer therapy that was expected to impair fertility
Who cannot join
- Prepubertal at diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Cancer
- Being tested
- online survey, focus group meeting
- Keywords
- cancer patients, male cancer patients, Decision Aid (DA), online Decision Aid tool
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online surveyOther
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 meetingOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Phase 2 focus group meeting (approx. 2 to 4 weeks after baseline)
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Phase 2 focus group meeting (approx. 2 to 4 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start2 Jan 2018
- Primary completion13 Feb 2020
- Study completion13 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Krebsforschung Schweiz, Bern, Switzerland
- Responsible party
- Sponsor
- Investigators
- Sibil Tschudin, PD Dr. med, Principal investigator, Frauenklinik Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876366
- Sponsor's protocol ID
- 2017-02069; sp19Tschudin
- Other IDs
- 2017
- Status last verified
- Mar 2020
- First submitted
- 26 Feb 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Preservation in Men Affected by Cancer: Assessment of Patients' Needs and Development of an Online Decision-aid
- ClinicalTrials.gov ID
- NCT03876366
- Acronym / sponsor ID
- 2017-02069; sp19Tschudin
- Conditions
- Cancer
- Keywords
- cancer patients, male cancer patients, Decision Aid (DA), online Decision Aid tool
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Krebsforschung Schweiz, Bern, Switzerland
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 13 Feb 2020 (actual)
- Study completion
- 13 Feb 2020 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- German speaking
- Cancer diagnosis within the last 10 years (minimum age at diagnosis 13 years)
- Cancer therapy that was expected to impair fertility
Key exclusion criteria (1 listed)
- Prepubertal at diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online surveyPart 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. | Other | – |
| focus group meetingPart 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. | Other | – |
Primary outcome
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
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
4 secondary outcomes
male cancer patients needs regarding decision-making about FP
Time frame: Phase 1 online survey at baseline
male cancer patients expectation with regard to an online DA tool about FP
Time frame: Phase 1 online survey at baseline
male cancer patients needs regarding decision-making about FP
Time frame: 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
Time frame: Phase 2 focus group meeting (approx. 2 to 4 weeks after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibil Tschudin, PD Dr. med principal investigator
Frauenklinik Universitätsspital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
male cancer patients level of information with regard to FP (time frame: Phase 1 online survey at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.