PRECISE: PancREatic Cancer and Individualised Supervised Exercise: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Feasibility - recruitment: number of participants that agree to participate or are excluded
研究概览
简要总结
The purpose of this study is to establish the feasibility of delivering a prescribed, individualised supervised aerobic and resistance exercise programme during adjuvant therapy, to improve survival and reduce symptom burden in pancreatic cancer
详细描述
Pancreatic ductal adenocarcinoma (PDAC) is the most common malignancy of the pancreas, representing 90% of all pancreatic neoplasms. The late presentation of symptoms and a lack of effective screening methods, means a large proportion (80-90%) are diagnosed with unresectable advanced disease, contributing to an unfavorable prognosis and dismal 5-year survival rate of ~5%. Intensive cancer treatments (i.e. surgery and chemotherapy) have debilitating complications including fatigue, pain and impaired physical function. Therefore, the maintenance of physical function and quality of life are seen as primary treatment goals for pancreatic patients, particularly during adjuvant therapy. Exercise training is emerging as an accepted component of patient care and evidence suggests regular exercise may induce an array of physiological and psychosocial benefits. However, there is a lack of evidence on the feasibility of delivering supervised exercise interventions to individuals with resectable PDAC undergoing adjuvant therapy. This study aims to explore the initial feasibility of delivering a supervised, individualized, and progressive concurrent exercise intervention to individuals with resectable PDAC who are undergoing adjuvant therapy, and provide data required to design a future randomized controlled trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years
- •histologically proven pancreatic ductal adenocarcinoma
- •complete macroscopic resection (R0 or R1 resection)
- •patients recovering from surgery in time for chemotherapy to be delivered with adjuvant intent
- •prior malignancy active within the previous 3 years other than locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •deemed medically fit by treating team to participate in exercise programme
- •able to provide informed consent.
排除标准
- •Macroscopically remaining tumour (R2 resection or tumour node metastasis (TNM) stage IV disease)
- •Pre-existing cardiac conditions; Congestive heart failure or recent serious cardiovascular event
- •Chest pain while undertaking physical activity
- •Any related co-morbidities (diabetes; unstable angina; degenerative neuromuscular disease; mental health disorders; substance abuse)
结局指标
主要结局
Feasibility - recruitment: number of participants that agree to participate or are excluded
时间窗: At baseline
The number of participants that agree to participate or are excluded
Feasibility - attrition: number of participants that withdraw from the study
时间窗: At conclusion of the 16 week exercise intervention
The number of participants that withdraw from the study
Feasibility - adherence to the exercise intervention: percentage of participants adhering to the exercise intervention
时间窗: At conclusion of the 16 week exercise intervention
Determine the percentage of participants adhering to the exercise intervention
Feasibility - participant experience: semi-structured interviews
时间窗: At conclusion of the 16 week exercise intervention
Determined by qualitative evaluation, using semi-structured interviews to assess experiences, accessibility and acceptability of the exercise intervention
次要结局
- Anthropometric assessment(At baseline, 16 weeks, 3 month follow-up)
- Hip and waist circumference analysis(At baseline, 16 weeks, 3 month follow-up)
- Functional muscle endurance assessment(At baseline, 16 weeks, 3 month follow-up)
- Physical fitness assessment(At baseline, 16 weeks, 3 month follow-up)
- Patient rated pain by questionnaire(At baseline, 16 weeks, 3 month follow-up)
- Well-being by questionnaire(At baseline, 16 weeks, 3 month follow-up)
- Health economics(At 16 weeks)
- Perceived physical activity levels(At baseline, 16 weeks, 3 month follow-up)
- Cancer-related fatigue by questionnaire(At baseline, 16 weeks, 3 month follow-up)
- Health related quality of life by questionnaire(At baseline, 16 weeks, 3 month follow-up)
研究者
Gillian Prue
Senior lecturer in chronic illness
Queen's University, Belfast