Development and Evaluation of a Fertility Preservation Patient Decision Aid for Women With Cancer.
22 de abril de 2016 actualizado por: 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.
Descripción general del estudio
Estado
Desconocido
Condiciones
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Anticipado)
98
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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South Yorkshire
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Sheffield, South Yorkshire, Reino Unido, S10 2JF
- Royal Hallamshire Hospital
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Sheffield, South Yorkshire, Reino Unido, 10 2SF
- Jessop Fertility
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Sheffield, South Yorkshire, Reino Unido, S10 2SJ
- Weston Park Hospital Cancer Charity
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West Yorkshire
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Leeds, West Yorkshire, Reino Unido, LS1 3EX
- Leeds General Infirmary
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Leeds, West Yorkshire, Reino Unido, LS9 7TF
- St James University Hospital
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Leeds, West Yorkshire, Reino Unido, LS14 6UH
- Leeds Centre for Reproductive Medicine
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
16 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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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Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in decisional conflict (Decisional Conflict Scale)
Periodo de tiempo: Baseline (within 3 days after initial treatment planning consultation); Time 2a- after completion of first round of chemotherapy (within 3 months after reading PDA)
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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.
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Baseline (within 3 days after initial treatment planning consultation); Time 2a- after completion of first round of chemotherapy (within 3 months after reading PDA)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Preparation for Decision Making Scale
Periodo de tiempo: Face validity stage (within one day after reading the PDA)
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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.
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Face validity stage (within one day after reading the PDA)
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Change in perception (Preparation for Decision Making Scale)
Periodo de tiempo: Time 1- the next oncology or fertility consultation (within one month after reading PDA)
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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.
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Time 1- the next oncology or fertility consultation (within one month after reading PDA)
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Change in decision making readiness (The Stage of Decision Making)
Periodo de tiempo: 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)
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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.
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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)
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The Decisional Regret Scale
Periodo de tiempo: Time 2b- after completion of first round of chemotherapy (within 3 months after reading the PDA)
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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.
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Time 2b- after completion of first round of chemotherapy (within 3 months after reading the PDA)
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Change in health outcomes (The EQ-5D)
Periodo de tiempo: 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)
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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.
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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)
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Change in anxiety (The State Trait Anxiety Inventory)
Periodo de tiempo: 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)
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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.
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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)
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Count Data
Periodo de tiempo: Through study completion (an average of 18 months)
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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.
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Through study completion (an average of 18 months)
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Learner Verification Questionnaire
Periodo de tiempo: Face validity stage (within one day of reading the PDA)
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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.
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Face validity stage (within one day of reading the PDA)
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Qualitative Interviews (telephone)
Periodo de tiempo: Face validity stage (within 1 week after reading the PDA)
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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.
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Face validity stage (within 1 week after reading the PDA)
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Qualitative Interviews (face to face)
Periodo de tiempo: Time 2b- after completion of first round of chemotherapy (up to 3 months after reading the PDA)
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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.
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Time 2b- after completion of first round of chemotherapy (up to 3 months after reading the PDA)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Georgina L Jones, D.Phil, Sheffield University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2016
Finalización primaria (Anticipado)
1 de junio de 2018
Finalización del estudio (Anticipado)
1 de junio de 2018
Fechas de registro del estudio
Enviado por primera vez
16 de abril de 2016
Primero enviado que cumplió con los criterios de control de calidad
22 de abril de 2016
Publicado por primera vez (Estimar)
27 de abril de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
27 de abril de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
22 de abril de 2016
Última verificación
1 de abril de 2016
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 142491
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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