Development and Evaluation of a Fertility Preservation Patient Decision Aid for Women With Cancer.
NCT ID: NCT02753296
Last Updated: 2016-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
98 participants
OBSERVATIONAL
2016-05-31
2018-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Exclusion Criteria
16 Years
FEMALE
No
Sponsors
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Yorkshire Cancer Research
OTHER
Weston Park Hospital Cancer Charity
OTHER
Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
Sheffield Hallam University
OTHER
University of Leeds
OTHER
The Leeds Teaching Hospitals NHS Trust
OTHER
Breast Cancer Care (Charity)
UNKNOWN
Independent Cancer Patients' Voice (Charity)
UNKNOWN
University of Oxford
OTHER
University of Sheffield
OTHER
Responsible Party
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Georgina Jones
Dr Georgina Jones- Reader in Social Sciences
Principal Investigators
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Georgina L Jones, D.Phil
Role: PRINCIPAL_INVESTIGATOR
Sheffield University
Locations
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Jessop Fertility
Sheffield, South Yorkshire, United Kingdom
Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom
Weston Park Hospital Cancer Charity
Sheffield, South Yorkshire, United Kingdom
Leeds General Infirmary
Leeds, West Yorkshire, United Kingdom
Leeds Centre for Reproductive Medicine
Leeds, West Yorkshire, United Kingdom
St James University Hospital
Leeds, West Yorkshire, United Kingdom
Countries
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Central Contacts
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References
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Jones GL, Hughes J, Mahmoodi N, Greenfield D, Brauten-Smith G, Skull J, Gath J, Yeomanson D, Baskind E, Snowden JA, Jacques RM, Velikova G, Collins K, Stark D, Phillips R, Lane S, Bekker HL; (On behalf of the Cancer, Fertility and Me research team). Observational study of the development and evaluation of a fertility preservation patient decision aid for teenage and adult women diagnosed with cancer: the Cancer, Fertility and Me research protocol. BMJ Open. 2017 Mar 13;7(3):e013219. doi: 10.1136/bmjopen-2016-013219.
Other Identifiers
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142491
Identifier Type: -
Identifier Source: org_study_id
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