Cancer Clinical Trial
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.
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.
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