Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Decisional Conflict of Young Cancer Patients With Regard to Fertility Preservation (Fertionco)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02404883
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
Swiss Bridge
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE March 19, 2015
First Posted Date  ICMJE April 1, 2015
Last Update Posted Date January 9, 2019
Actual Study Start Date  ICMJE October 2014
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2015)
  • change (reduction) of decisional regret (Decisional Regret Scale) [ Time Frame: twice: 1 month after fertility preservation counseling, 12 month after counseling ]
    with the Decisional Regret Scale
  • change (increase) of knowledge about fertility preservation (questionnaire) [ Time Frame: twice: within 5 days after fertility preservation counseling, 1 month after counseling ]
    with a questionnaire which assess the knowledge about various fertility preservation methods
  • helpfulness and satisfaction of decision-aid tool (questionnaire) [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Decisional Conflict of Young Cancer Patients With Regard to Fertility Preservation
Official Title  ICMJE Decisional Conflict of Young Cancer Patients With Regard to Fertility Preservation - Effects of an Online Decision-aid Tool
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer
Intervention  ICMJE Other: Online Decision-Aid Tool
Study Arms  ICMJE
  • No Intervention: control group
    care as usual (fertility preservation counseling)
  • Experimental: intervention group
    Intervention: use of an online decision-aid tool after fertility preservation counseling
    Intervention: Other: Online Decision-Aid Tool
Publications * Ehrbar V, Urech C, Rochlitz C, Zanetti Dällenbach 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2018)
79
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2015)
120
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02404883
Other Study ID Numbers  ICMJE 2014-265
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Swiss Bridge
Investigators  ICMJE
Principal Investigator: Sibil Tschudin, PD Dr. med. Universitätsspital Basel Frauenklinik
PRS Account University Hospital, Basel, Switzerland
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP