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Development and Evaluation of a Fertility Preservation Patient Decision Aid for Women With Cancer.

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02753296
Study type Observational
Source University of Sheffield
Contact Georgina L Jones, D.Phil
Phone 0114 222 0806
Email g.l.jones@sheffield.ac.uk
Status Not yet recruiting
Phase N/A
Start date May 2016
Completion date June 2018
View Details
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