The Use and Development of Patient Reported Outcome Measures (PROMs) in the Adoptive Cell Therapy (ACT) Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Draft Adoptive Cell Therapy Patient Reported Outcome Measure (ACT-PROM) Baseline
研究概览
简要总结
The goals of this observational study is to
- To develop an Adoptive Cell Therapy (ACT)-specific PROM (Patient Reported Outcome Measure) to assess quality of life and symptomatology
- To develop guidelines/recommendations for the use of PROMs in ACT trials
Participants will be recruited in four separate stages:
Stage 1: Semi-structured interviews to generate PROM items. Stage 2: Cognitive interviews to ensure that all items are clear and easily understood.
Stage 3: Initial pilot of the draft PROM to enable item reduction and refinement.
Stage 4: Pilot of final PROM to assess acceptability in a clinical setting.
详细描述
The goals of this observational study is to
- To develop an Adoptive Cell Therapy (ACT)-specific PROM (Patient Reported Outcome Measure) to assess quality of life and symptomatology
- To develop guidelines/recommendations for the use of PROMs in ACT trials
Participants will be patients who have taken part in ACT clinical trials.
Stage I - Item generation Approximately 20 participant interviews will be conducted with ACT patients to capture their experiences of receiving ACTs including quality of life, symptom experience, adverse events and other relevant themes that may emerge. The investigators will aim to recruit a minimum of 3 participants in each of the following groups: Pre-infusion; Acute (treatment- 30 days post treatment; Sub-acute- up to 12 months post treatment; Long-term follow-up- from 12 months post treatment onwards. The interviews will be audio recorded and transcribed verbatim. The qualitative data will be analysed thematically and key quotes extracted which will be used to create a draft item list. Interviews will be conducted either in person or virtually depending on national social distancing guidance at the time.
Stage II - Cognitive interviewing Following the creation of a draft item list, approximately 5 participants from Stage I and 3-5 study naïve patients will undergo cognitive interviews to ensure that all items are clear and easily understood. The investigators will also explore patient preferences for the layout of the questionnaire, time recall and overall application issues. Investigators will aim to include a range of participants in each of the four groups outlined above.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are enrolled on Adoptive Cell Therapy (ACT) trial
- •Aged over 16 (no upper age limit)
- •Ability to understand and communicate in the English language
- •Able to provide written informed consent
排除标准
- •Aged under 16
- •Unable to understand and communicate in the English language
- •Unable to provide written informed consent
结局指标
主要结局
Draft Adoptive Cell Therapy Patient Reported Outcome Measure (ACT-PROM) Baseline
时间窗: 100 participants receiving ACT will complete the PROM upon recruitment,
Draft PROM pilot tested in stage 3 of the study. Content is determined in the first 2 stages of the study.
Draft Adoptive Cell Therapy Patient Reported Outcome Measure (ACT-PROM) 7 days post baseline
时间窗: 50 of the 100 participants completing the PROM at baseline will repeat the PROM 1 week later.
Draft PROM pilot tested in stage 3 of the study. Content is determined in the first 2 stages of the study. This will be compared to baseline to determine test-retest reliability.
次要结局
- Functional Assessment of Cancer Therapy - General (FACT-G)(Completed during stage 3 of the study at baseline with the draft PROM.)
- European Organisation for Research and Treatment of Cancer Satisfaction with Cancer Care Core Questionnaire (EORTC PATSATC33)(Completed during stage 3 of the study at baseline with the draft PROM.)