Development and Evaluation of a Patient Fertility Preservation Decision Aid for Women With Cancer: The Cancer, Fertility and Me Research Study
试验速览
- 阶段
- 不适用
- 入组人数
- 98
- 试验地点
- 6
- 主要终点
- Change in decisional conflict (Decisional Conflict Scale)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women aged >16 of a reproductive age, with a diagnosis of any cancer, undergoing cancer treatment(s) which may impact fertility
排除标准
- •Women who have started menopause/ not of a reproductive age
结局指标
主要结局
Change in decisional conflict (Decisional Conflict Scale)
时间窗: 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.
次要结局
- Change in perception (Preparation for Decision Making Scale)(Time 1- the next oncology or fertility consultation (within one month after reading PDA))
- Learner Verification Questionnaire(Face validity stage (within one day of reading the PDA))
- The Decisional Regret Scale(Time 2b- after completion of first round of chemotherapy (within 3 months after reading the PDA))
- Change in anxiety (The State Trait Anxiety Inventory)(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(Through study completion (an average of 18 months))
- Qualitative Interviews (telephone)(Face validity stage (within 1 week after reading the PDA))
- Preparation for Decision Making Scale(Face validity stage (within one day after reading the PDA))
- Change in decision making readiness (The Stage of Decision Making)(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))
- Change in health outcomes (The EQ-5D)(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))
- Qualitative Interviews (face to face)(Time 2b- after completion of first round of chemotherapy (up to 3 months after reading the PDA))
研究者
Georgina Jones
Dr Georgina Jones- Reader in Social Sciences
University of Sheffield