Decisional Conflict of Young Cancer Patients With Regard to Fertility Preservation
Condition: Cancer
Study type: Interventional

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.
    

Intervention name(s): Online Decision-Aid Tool
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cancer; decisional conflict; online; decision-aid tool