NCT02753296

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

2.1 years

First QC Date

April 16, 2016

Last Update Submit

April 22, 2016

Conditions

Cancer

Keywords

CancerFertility PreservationPatient Decision Aid

Outcome Measures

Primary Outcomes (1)

  • Change in decisional conflict (Decisional Conflict Scale)

    This is a 16-item measure measuring the conflict inherent in the treatment decision encountered. Scores \> 37.5 on the overall scale (range 0-100) indicate high decisional conflict, which is characterised by decision delay and/or uncertainty about decision. This will be administered to women.

    Baseline (within 3 days after initial treatment planning consultation); Time 2a- after completion of first round of chemotherapy (within 3 months after reading PDA)

Secondary Outcomes (10)

  • Preparation for Decision Making Scale

    Face validity stage (within one day after reading the PDA)

  • Change in perception (Preparation for Decision Making Scale)

    Time 1- the next oncology or fertility consultation (within one month after reading PDA)

  • Change in decision making readiness (The Stage of Decision Making)

    Baseline (within 3 days after initial treatment planning consultation); Time 1- the next oncology or fertility consultation (within one month after reading PDA); Time 2a- after completion of first round of chemotherapy (within 3 months after reading PDA)

  • The Decisional Regret Scale

    Time 2b- after completion of first round of chemotherapy (within 3 months after reading the PDA)

  • Change in health outcomes (The EQ-5D)

    Baseline (within 3 days after initial treatment planning consultation); Time 2b- after completion of first round of chemotherapy (within 3 months after reading the PDA)

  • +5 more secondary outcomes

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All women of a reproductive age (16yrs+), who have been diagnosed with cancer, and are undergoing or has undergone cancer treatment(s) which may impact fertility will be eligible. The sample of women will be opportunistic and identified from those women referred to the study sites.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Jessop Fertility

Sheffield, South Yorkshire, 10 2SF, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Weston Park Hospital Cancer Charity

Sheffield, South Yorkshire, S10 2SJ, United Kingdom

Location

Leeds General Infirmary

Leeds, West Yorkshire, LS1 3EX, United Kingdom

Location

Leeds Centre for Reproductive Medicine

Leeds, West Yorkshire, LS14 6UH, United Kingdom

Location

St James University Hospital

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 28289046DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Georgina L Jones, D.Phil

    Sheffield University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgina L Jones, D.Phil

CONTACT

0114 222 0806g.l.jones@sheffield.ac.uk

Jane Hughes, MPH

CONTACT

0114 222 4329jane.hughes2@heffield.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Georgina Jones- Reader in Social Sciences

Study Record Dates

First Submitted

April 16, 2016

First Posted

April 27, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

April 27, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(6)