Cancer Clinical Trial
Official title:
Development and Evaluation of a Patient Fertility Preservation Decision Aid for Women With Cancer: The Cancer, Fertility and Me Research Study
The aim of this research study is to develop a patient decision aid (PDA), and evaluate whether its integration within oncology services enable cancer services to effectively support and provide evidence based resources for women's fertility preservation decisions, following a diagnosis of any cancer type.
Women diagnosed with cancer have to make time-pressured decisions regarding fertility
preservation with specialist fertility services whilst planning their cancer treatment with
oncology services. Oncologists identify a need for resources enabling them to support
women's fertility preservation decisions more effectively; and women report wanting more
specialist information to make these choices across service pathways. This research will
develop a new evidence-based patient decision aid (PDA) to address this unmet need and
evaluate its acceptability to women and services when integrated into usual cancer care
pathways at the point of cancer diagnosis and treatment planning.
The objectives are to:
1. Develop a PDA for use by oncology teams to support women making fertility preservation
choices, whilst having a recent cancer diagnosis.
2. Assess the validity of the PDA to support women making informed decisions about
fertility preservation before starting their cancer treatment.
3. Evaluate the acceptability of the PDA to a) women making fertility preservation
decisions whilst planning their cancer treatment and b) oncology and fertility health
professionals supporting women's oncology and fertility treatment choices.
This research employs a series of prospective, observational surveys, employing both
quantitative and qualitative methods to develop and evaluate the PDA.
Data will be collected during 5 time points:
1. Face validity stage- The purpose of this stage is to assess the face validity of the
PDA from women and health professionals. Qualitative and quantitative data collection
will aim to explore understanding, the purpose of the PDA, and views on its utility.
2. Evaluation Stage Baseline- Quantitative data collected from eligible women following
their initial treatment planning consultation. Questionnaires are completed prior to
reading the PDA.
3. Evaluation Stage Time 1- Quantitative data collected from eligible women on arrival to
their appointment at the Assisted Conception Unit (ACU). For those women who decide not
to attend their appointment with the fertility expert the questionnaires will be either
posted or handed to them at their next oncology appointment for completion, at the same
time point.
4. Evaluation Stage Time 2a- Quantitative data collected from eligible women following
completion of their first round of chemotherapy.
5. Evaluation Stage Time 2b- Qualitative interview data collected from eligible women
following completion of their first round of chemotherapy, and from health
professionals.
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Observational Model: Cohort, Time Perspective: Prospective
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