- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02404883
Decisional Conflict of Young Cancer Patients With Regard to Fertility Preservation (Fertionco)
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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Basel-Stadt
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Basel, Basel-Stadt, Svizzera, 4031
- Universitätsspital Frauenklinik
-
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 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
Exclusion Criteria:
- Cancer treatment not affecting reproductive function
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: control group
care as usual (fertility preservation counseling)
|
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Sperimentale: intervention group
Intervention: use of an online decision-aid tool after fertility preservation counseling
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
change (reduction) of decisional conflict (Decisional Conflict Scale)
Lasso di tempo: 3 times: within 5 days after fertility preservation counseling, one month after counseling, 12 month after counseling
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with the
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3 times: within 5 days after fertility preservation counseling, one month after counseling, 12 month after counseling
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
change (reduction) of decisional regret (Decisional Regret Scale)
Lasso di tempo: twice: 1 month after fertility preservation counseling, 12 month after counseling
|
with the Decisional Regret Scale
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twice: 1 month after fertility preservation counseling, 12 month after counseling
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change (increase) of knowledge about fertility preservation (questionnaire)
Lasso di tempo: twice: within 5 days after fertility preservation counseling, 1 month after counseling
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with a questionnaire which assess the knowledge about various fertility preservation methods
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twice: within 5 days after fertility preservation counseling, 1 month after counseling
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helpfulness and satisfaction of decision-aid tool (questionnaire)
Lasso di tempo: twice: within 5 days after fertility preservation counseling, 1 month after counseling
|
questionnaire to assess helpfulness and satisfaction of tool only for the intervention group, who used the decision-aid tool
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twice: within 5 days after fertility preservation counseling, 1 month after counseling
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Sibil Tschudin, PD Dr. med., Universitätsspital Basel Frauenklinik
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 2014-265
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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