CancerFertioncoNCT02404883
Decisional Conflict of Young Cancer Patients With Regard to Fertility Preservation
A study testing Online Decision-Aid Tool in people with Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Women who are diagnosed with cancer during their reproductive lifespan might be confronted with impaired fertility. Nowadays a number of fertility preservation options are available. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women only
- Conditions the study is for
- Cancer
- What is being tested?
- Online Decision-Aid Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2014to Dec 2018
- Phase
- Interventional
- 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 16 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female patients
- Age 16 to 40 years
- German speaking
- Access to a computer
- Pre-menopausal at time of diagnosis
- Not yet having started (adjuvant) cancer therapy
- family planning not completed
Who cannot join
- Cancer treatment not affecting reproductive function
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitätsspital Frauenklinik
Basel, Canton of Basel-City, 4031
About this study
Official title: Decisional Conflict of Young Cancer Patients With Regard to Fertility Preservation - Effects of an Online Decision-aid Tool
Women who are diagnosed with cancer during their reproductive lifespan might be confronted with impaired fertility. Nowadays a number of fertility preservation options are available. Decisions about whether and how to protect fertility have to be made in a very short time period, right after cancer diagnosis and before start of treatment. The psychological impact for patients is considerable. This project aims at developing a standardized decision-aid tool to support the decision-making process about fertility preservation in young cancer patients. It is designed as an online decision-aid tool. A web-based tool is perfectly designed for this target group and offers new possibilities providing flexible and individually tailored information.
The aim of the study is to examine the benefits of the online decision-aid tool compared with standard counseling (usual care). Decisional conflict is measured immediately after counseling as well as one month later. One year after counseling, decisional regret is being evaluated additionally. If the decision-aid tool proves to be helpful and useful, the online design allows making it available for a wide range of concerned patients.
Read the detailed description
Background: Impaired fertility is often a consequence of successful cancer treatment and fertility preservation (FP) is nowadays an option for young cancer survivors. Decisions on FP, however, have to be made in the short time period after cancer diagnosis and before onset of treatment. According to previous studies the availability of helpful information is still low, decisional conflict substantial and decisions-aids would be highly desirable.
Objectives: The project aims at introducing the knowledge gained by the previous research into the development of a standardized online decision aid (DA) that complements and supports shared decision-making in fertility issues and FP for young cancer patients and their medical caretakers and to evaluate the efficacy of this DA compared with usual care. Primary objective: To show that an online decision-aid tool in addition to standard counselling reduces decisional conflict compared to standard counselling alone. Secondary objectives: 1) to assess whether the decision-aid tool decreases decisional regret significantly, 2) to assess whether the use of the decision-aid tool increases the patients' knowledge on FP and 3) to assess whether patients estimate the decision-aid tool helpful in facilitating the decision-making process.
Methods: Design: Prospective, consecutive interventional study comparing a control group with standard counselling (phase 1) with an interventional group with counselling and application of the DA (phase 2). After completing phase 1 and 2 with a sample of 40 participants, we change the study design into a randomized controlled trial and randomize 88 participants in this part of the study. Sample: A total of 120 young cancer patients followed at one of the collaborating Swiss or German cancer centers aged 16 to 40 years who are possible candidates for FP . Intervention: Online DA, which is developed based on the applicants' research findings and on a prospectively evaluated fertility-related Australian decision aid booklet. Measures: Decisional Conflict Scale (DCS); items on knowledge, attitude and willingness concerning FP; decision regret scale (DRS); items on satisfaction and helpfulness of the DA.
Procedures: The control and the interventions group completes the questionnaires at three time points, i.e. immediately after the counselling (T1), after 1 month (T2) and after 12 months (T3).
Analysis and statistics: The difference in decisional conflict between the two groups will be analyzed by using a one-way analysis of variance (ANOVA) and a propensity score weighted ANOVA to adjust for confounding variables.
- Conditions
- Cancer
- Being tested
- Online Decision-Aid Tool
- Keywords
- Cancer, decisional conflict, 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 Decision-Aid ToolOther
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | care as usual (fertility preservation counseling) |
| intervention group | Experimental | Intervention: use of an online decision-aid tool after fertility preservation counseling Receives: Other: Online Decision-Aid Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
change (reduction) of decisional conflict (Decisional Conflict Scale)
with the
Measured: 3 times: within 5 days after fertility preservation counseling, one month after counseling, 12 month after counseling
Secondary outcomes (3)
change (reduction) of decisional regret (Decisional Regret Scale)
with the Decisional Regret Scale
Measured: twice: 1 month after fertility preservation counseling, 12 month after counseling
change (increase) of knowledge about fertility preservation (questionnaire)
with a questionnaire which assess the knowledge about various fertility preservation methods
Measured: twice: within 5 days after fertility preservation counseling, 1 month after counseling
helpfulness and satisfaction of decision-aid tool (questionnaire)
questionnaire to assess helpfulness and satisfaction of tool only for the intervention group, who used the decision-aid tool
Measured: twice: within 5 days after fertility preservation counseling, 1 month after counseling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Bridge
- Responsible party
- Sponsor
- Investigators
- Sibil Tschudin, PD Dr. med., Principal investigator, Universitätsspital Basel Frauenklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404883
- Sponsor's protocol ID
- 2014-265
- Acronym
- Fertionco
- Status last verified
- Jan 2019
- First submitted
- 19 Mar 2015
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ehrbar V, Urech C, Rochlitz C, Zanetti Dallenbach R, Moffat R, Stiller R, Germeyer A, Nawroth F, Dangel A, Findeklee S, Tschudin S. Randomized controlled trial on the effect of an online decision aid for young female cancer patients regarding fertility preservation. Hum Reprod. 2019 Sep 29;34(9):1726-1734. doi: 10.1093/humrep/dez136.
PubMed 31398258
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decisional Conflict of Young Cancer Patients With Regard to Fertility Preservation - Effects of an Online Decision-aid Tool
- ClinicalTrials.gov ID
- NCT02404883
- Acronym / sponsor ID
- Fertionco / 2014-265
- Conditions
- Cancer
- Keywords
- Cancer, decisional conflict, online, decision-aid tool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss Bridge
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 1 Apr 2015 (estimated)
- 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.
Women who are diagnosed with cancer during their reproductive lifespan might be confronted with impaired fertility. Nowadays a number of fertility preservation options are available. Decisions about whether and how to protect fertility have to be made in a very short time period, right after cancer diagnosis and before start of treatment. The psychological impact for patients is considerable. This project aims at developing a standardized decision-aid tool to support the decision-making process about fertility preservation in young cancer patients. It is designed as an online decision-aid tool. A web-based tool is perfectly designed for this target group and offers new possibilities providing flexible and individually tailored information.
The aim of the study is to examine the benefits of the online decision-aid tool compared with standard counseling (usual care). Decisional conflict is measured immediately after counseling as well as one month later. One year after counseling, decisional regret is being evaluated additionally. If the decision-aid tool proves to be helpful and useful, the online design allows making it available for a wide range of concerned patients.
Detailed description
Background: Impaired fertility is often a consequence of successful cancer treatment and fertility preservation (FP) is nowadays an option for young cancer survivors. Decisions on FP, however, have to be made in the short time period after cancer diagnosis and before onset of treatment. According to previous studies the availability of helpful information is still low, decisional conflict substantial and decisions-aids would be highly desirable.
Objectives: The project aims at introducing the knowledge gained by the previous research into the development of a standardized online decision aid (DA) that complements and supports shared decision-making in fertility issues and FP for young cancer patients and their medical caretakers and to evaluate the efficacy of this DA compared with usual care. Primary objective: To show that an online decision-aid tool in addition to standard counselling reduces decisional conflict compared to standard counselling alone. Secondary objectives: 1) to assess whether the decision-aid tool decreases decisional regret significantly, 2) to assess whether the use of the decision-aid tool increases the patients' knowledge on FP and 3) to assess whether patients estimate the decision-aid tool helpful in facilitating the decision-making process.
Methods: Design: Prospective, consecutive interventional study comparing a control group with standard counselling (phase 1) with an interventional group with counselling and application of the DA (phase 2). After completing phase 1 and 2 with a sample of 40 participants, we change the study design into a randomized controlled trial and randomize 88 participants in this part of the study. Sample: A total of 120 young cancer patients followed at one of the collaborating Swiss or German cancer centers aged 16 to 40 years who are possible candidates for FP . Intervention: Online DA, which is developed based on the applicants' research findings and on a prospectively evaluated fertility-related Australian decision aid booklet. Measures: Decisional Conflict Scale (DCS); items on knowledge, attitude and willingness concerning FP; decision regret scale (DRS); items on satisfaction and helpfulness of the DA.
Procedures: The control and the interventions group completes the questionnaires at three time points, i.e. immediately after the counselling (T1), after 1 month (T2) and after 12 months (T3).
Analysis and statistics: The difference in decisional conflict between the two groups will be analyzed by using a one-way analysis of variance (ANOVA) and a propensity score weighted ANOVA to adjust for confounding variables.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –care as usual (fertility preservation counseling) |
| intervention group | Experimental | Other: Online Decision-Aid ToolIntervention: use of an online decision-aid tool after fertility preservation counseling |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Female patients
- Age 16 to 40 years
- German speaking
- Access to a computer
- Pre-menopausal at time of diagnosis
Key exclusion criteria (1 listed)
- Cancer treatment not affecting reproductive function
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 Decision-Aid Tool | Other | intervention group |
Primary outcome
change (reduction) of decisional conflict (Decisional Conflict Scale)
Time frame: 3 times: within 5 days after fertility preservation counseling, one month after counseling, 12 month after counseling
with the
3 secondary outcomes
change (reduction) of decisional regret (Decisional Regret Scale)
Time frame: twice: 1 month after fertility preservation counseling, 12 month after counseling
change (increase) of knowledge about fertility preservation (questionnaire)
Time frame: twice: within 5 days after fertility preservation counseling, 1 month after counseling
helpfulness and satisfaction of decision-aid tool (questionnaire)
Time frame: twice: within 5 days after fertility preservation counseling, 1 month after counseling
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 9 Jan 2019.
- Derived from this study: PubMed 31398258Ehrbar V, Urech C, Rochlitz C, Zanetti Dallenbach R, Moffat R, Stiller R, Germeyer A, Nawroth F, Dangel A, Findeklee S, Tschudin S. Randomized controlled trial on the effect of an online decision aid for young female cancer patients regarding fertility preservation. Hum Reprod. 2019 Sep 29;34(9):1726-1734. doi: 10.1093/humrep/dez136.
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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
Universitätsspital Basel Frauenklinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Decision-Aid Tool in people with 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 7 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 9 Jan 2019. 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?
change (reduction) of decisional conflict (Decisional Conflict Scale) (time frame: 3 times: within 5 days after fertility preservation counseling, one month after counseling, 12 month after counseling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02404883, which also lists 1 linked publication.
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 9 Jan 2019.