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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02753296
Recruitment Status : Unknown
Verified April 2016 by Georgina Jones, University of Sheffield.
Recruitment status was:  Not yet recruiting
First Posted : April 27, 2016
Last Update Posted : April 27, 2016
Sponsor:
Collaborators:
Yorkshire Cancer Research
Weston Park Hospital Cancer Charity
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Hallam University
University of Leeds
The Leeds Teaching Hospitals NHS Trust
Breast Cancer Care (Charity)
Independent Cancer Patients' Voice (Charity)
University of Oxford
Information provided by (Responsible Party):
Georgina Jones, University of Sheffield

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.

Condition or disease
Cancer

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 98 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development and Evaluation of a Patient Fertility Preservation Decision Aid for Women With Cancer: The Cancer, Fertility and Me Research Study
Study Start Date : May 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018



Primary Outcome Measures :
  1. Change in decisional conflict (Decisional Conflict Scale) [ Time Frame: Baseline (within 3 days after initial treatment planning consultation); Time 2a- after completion of first round of chemotherapy (within 3 months after reading PDA) ]
    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.


Secondary Outcome Measures :
  1. Preparation for Decision Making Scale [ Time Frame: Face validity stage (within one day after reading the PDA) ]
    This is a 10-item measure which assesses an individual's perception of how useful a DA is in preparing the respondent to communicate with their practitioner at a consultation focused on making a health decision. High scores on the overall scale (range 0-100) indicate higher perceived levels of preparation for decision making. It will be administered to women and health professionals.

  2. Change in perception (Preparation for Decision Making Scale) [ Time Frame: Time 1- the next oncology or fertility consultation (within one month after reading PDA) ]
    This is a 10-item measure which assesses an individual's perception of how useful a DA is in preparing the respondent to communicate with their practitioner at a consultation focused on making a health decision. High scores on the overall scale (range 0-100) indicate higher perceived levels of preparation for decision making. This will be administered to women.

  3. Change in decision making readiness (The Stage of Decision Making) [ Time Frame: 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) ]
    This is a 6 category tool to assess the individual's readiness to engage in decision making, progress in making a choice, and receptivity to considering or re-considering options. Scores are rated 1-6 from not thinking about it at all, to considered options. This will be administered to women.

  4. The Decisional Regret Scale [ Time Frame: Time 2b- after completion of first round of chemotherapy (within 3 months after reading the PDA) ]
    This is a brief 5-item scale which measures "distress or remorse after a health care decision" using a 5-point Likert scale (1- strongly agree; 5- strongly disagree). A score of 0 on the overall scale (range 0-100) indicates no regret; scores of 100 mean high regret. This will be administered to women.

  5. Change in health outcomes (The EQ-5D) [ Time Frame: 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) ]
    This is a standardised instrument for use as a measure of health outcome. It consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. This will be administered to women.

  6. Change in anxiety (The State Trait Anxiety Inventory) [ Time Frame: 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) ]
    This is a brief 6-item version used to measure of state anxiety. All items are rated on a 4-point scale (1-Almost never, 4-Almost always). Higher scores indicate greater anxiety. This will be administered to women.

  7. Count Data [ Time Frame: Through study completion (an average of 18 months) ]
    Count data will be collected of the number of DAs given to women and clinical staff, counts of use, and number of clicks on the 'Cancer, Fertility and Me' website will be recorded. In addition we will record length of oncology and fertility consultations, and length of time to fertility and cancer treatment.

  8. Learner Verification Questionnaire [ Time Frame: Face validity stage (within one day of reading the PDA) ]
    This will consist of 4 items taken from the QQ-10, which is a measure of face validity which has been used in previous studies. The 4 items will be measured on and a 5-point Likert scale (1- strongly agree; 5- strongly disagree). The questionnaire will also comprise of 3 open end questions relating to the acceptability and utility of the PDA from womens and health professionals perspective. This will be administered to women and health professionals.

  9. Qualitative Interviews (telephone) [ Time Frame: Face validity stage (within 1 week after reading the PDA) ]
    The telephone interview will take place with women and health professionals. The interview schedule will focus Learner Verification (LV) (modified from an existing LV interview schedule) to seek further clarification on answers provided on the questionnaire, and to gain more in-depth information.

  10. Qualitative Interviews (face to face) [ Time Frame: Time 2b- after completion of first round of chemotherapy (up to 3 months after reading the PDA) ]
    The interview will take place with women. The interview schedule for the face to face interviews will focus on Learner Verification (LV) (modified from an existing LV interview schedule) to explore the PDAs clarity and usefulness in planning care and making decisions between treatment options. Additional areas the interview schedule will focus on include the PDAs likelihood of use, barriers to use in practice, whether or not the women and health professionals benefit from their delivery, usefulness of the PDA in aiding service transition, and how the women used the PDA.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria: All women aged >16 of a reproductive age, with a diagnosis of any cancer, undergoing cancer treatment(s) which may impact fertility

Exclusion Criteria: Women who have started menopause/ not of a reproductive age

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753296


Contacts
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Contact: Georgina L Jones, D.Phil 0114 222 0806 g.l.jones@sheffield.ac.uk
Contact: Jane Hughes, MPH 0114 222 4329 jane.hughes2@heffield.ac.uk

Locations
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United Kingdom
Jessop Fertility
Sheffield, South Yorkshire, United Kingdom, 10 2SF
Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Weston Park Hospital Cancer Charity
Sheffield, South Yorkshire, United Kingdom, S10 2SJ
Leeds General Infirmary
Leeds, West Yorkshire, United Kingdom, LS1 3EX
Leeds Centre for Reproductive Medicine
Leeds, West Yorkshire, United Kingdom, LS14 6UH
St James University Hospital
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Sponsors and Collaborators
University of Sheffield
Yorkshire Cancer Research
Weston Park Hospital Cancer Charity
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Hallam University
University of Leeds
The Leeds Teaching Hospitals NHS Trust
Breast Cancer Care (Charity)
Independent Cancer Patients' Voice (Charity)
University of Oxford
Investigators
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Principal Investigator: Georgina L Jones, D.Phil Sheffield University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Georgina Jones, Dr Georgina Jones- Reader in Social Sciences, University of Sheffield
ClinicalTrials.gov Identifier: NCT02753296    
Other Study ID Numbers: 142491
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Georgina Jones, University of Sheffield:
Cancer
Fertility Preservation
Patient Decision Aid