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

22 kwietnia 2016 zaktualizowane przez: 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.

Przegląd badań

Status

Nieznany

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Oczekiwany)

98

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

16 lat i starsze (Dziecko, Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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

-

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in decisional conflict (Decisional Conflict Scale)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Preparation for Decision Making Scale
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Sheffield

Współpracownicy

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)

Śledczy

  • Główny śledczy: Georgina L Jones, D.Phil, Sheffield University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 maja 2016

Zakończenie podstawowe (Oczekiwany)

1 czerwca 2018

Ukończenie studiów (Oczekiwany)

1 czerwca 2018

Daty rejestracji na studia

Pierwszy przesłany

16 kwietnia 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

22 kwietnia 2016

Pierwszy wysłany (Oszacować)

27 kwietnia 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

27 kwietnia 2016

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 kwietnia 2016

Ostatnia weryfikacja

1 kwietnia 2016

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • 142491

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

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