このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。英語版ソーステキスト用。

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

2016年4月22日更新者：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.

調査の概要

状態

わからない

条件

詳細な説明

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:

Develop a PDA for use by oncology teams to support women making fertility preservation choices, whilst having a recent cancer diagnosis.
Assess the validity of the PDA to support women making informed decisions about fertility preservation before starting their cancer treatment.
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:

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.
Evaluation Stage Baseline- Quantitative data collected from eligible women following their initial treatment planning consultation. Questionnaires are completed prior to reading the PDA.
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.
Evaluation Stage Time 2a- Quantitative data collected from eligible women following completion of their first round of chemotherapy.
Evaluation Stage Time 2b- Qualitative interview data collected from eligible women following completion of their first round of chemotherapy, and from health professionals.

研究の種類

観察的

入学 (予想される)

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

16年歳以上 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Change in decisional conflict (Decisional Conflict Scale) 時間枠：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)

二次結果の測定

結果測定	メジャーの説明	時間枠
Preparation for Decision Making Scale 時間枠：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) 時間枠：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) 時間枠：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 時間枠：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) 時間枠：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) 時間枠：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 時間枠：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 時間枠：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) 時間枠：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) 時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Sheffield

協力者

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)

捜査官

主任研究者：Georgina L Jones, D.Phil、Sheffield University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2016年5月1日

一次修了 (予想される)

2018年6月1日

研究の完了 (予想される)

2018年6月1日

試験登録日

最初に提出

2016年4月16日

QC基準を満たした最初の提出物

2016年4月22日

最初の投稿 (見積もり)

2016年4月27日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年4月27日

QC基準を満たした最後の更新が送信されました