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

22 april 2016 bijgewerkt door: Georgina Jones, University of Sheffield

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.

Studie Overzicht

Toestand

Onbekend

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Verwacht)

98

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigd Koninkrijk
    • South Yorkshire
      • Sheffield, South Yorkshire, Verenigd Koninkrijk, S10 2JF
        • Royal Hallamshire Hospital
      • Sheffield, South Yorkshire, Verenigd Koninkrijk, 10 2SF
        • Jessop Fertility
      • Sheffield, South Yorkshire, Verenigd Koninkrijk, S10 2SJ
        • Weston Park Hospital Cancer Charity
    • West Yorkshire
      • Leeds, West Yorkshire, Verenigd Koninkrijk, LS1 3EX
        • Leeds General Infirmary
      • Leeds, West Yorkshire, Verenigd Koninkrijk, LS9 7TF
        • St James University Hospital
      • Leeds, West Yorkshire, Verenigd Koninkrijk, LS14 6UH
        • Leeds Centre for Reproductive Medicine

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

16 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

-

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in decisional conflict (Decisional Conflict Scale)
Tijdsspanne: 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.
Baseline (within 3 days after initial treatment planning consultation); Time 2a- after completion of first round of chemotherapy (within 3 months after reading PDA)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Preparation for Decision Making Scale
Tijdsspanne: 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.
Face validity stage (within one day after reading the PDA)
Change in perception (Preparation for Decision Making Scale)
Tijdsspanne: 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.
Time 1- the next oncology or fertility consultation (within one month after reading PDA)
Change in decision making readiness (The Stage of Decision Making)
Tijdsspanne: 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.
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
Tijdsspanne: 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.
Time 2b- after completion of first round of chemotherapy (within 3 months after reading the PDA)
Change in health outcomes (The EQ-5D)
Tijdsspanne: 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.
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)
Change in anxiety (The State Trait Anxiety Inventory)
Tijdsspanne: 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.
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)
Count Data
Tijdsspanne: 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.
Through study completion (an average of 18 months)
Learner Verification Questionnaire
Tijdsspanne: 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.
Face validity stage (within one day of reading the PDA)
Qualitative Interviews (telephone)
Tijdsspanne: 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.
Face validity stage (within 1 week after reading the PDA)
Qualitative Interviews (face to face)
Tijdsspanne: 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.
Time 2b- after completion of first round of chemotherapy (up to 3 months after reading the PDA)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Sheffield

Medewerkers

The Leeds Teaching Hospitals NHS Trust
University of Leeds
University of Oxford
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Hallam University
Yorkshire Cancer Research
Weston Park Hospital Cancer Charity
Breast Cancer Care (Charity)
Independent Cancer Patients' Voice (Charity)

Onderzoekers

  • Hoofdonderzoeker: Georgina L Jones, D.Phil, Sheffield University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2016

Primaire voltooiing (Verwacht)

1 juni 2018

Studie voltooiing (Verwacht)

1 juni 2018

Studieregistratiedata

Eerst ingediend

16 april 2016

Eerst ingediend dat voldeed aan de QC-criteria

22 april 2016

Eerst geplaatst (Schatting)

27 april 2016

Updates van studierecords

Laatste update geplaatst (Schatting)

27 april 2016

Laatste update ingediend die voldeed aan QC-criteria

22 april 2016

Laatst geverifieerd

1 april 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 142491

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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