Engaging the Older Cancer Patient; Patient Activation Through Counseling, Exercise and Mobilization - Pancreatic, Biliary Tract, and Lung Cancer (PACE-Mobil-PBL) - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Lower body strength measured with the 30-second chair stand test
研究概览
简要总结
PACE-Mobil-PBL is a prospective randomized controlled trial. The aim is to investigate the effect of a multimodal and exercise-based intervention among older patients with advanced pancreatic cancer, biliary tract cancer, or lung cancer during treatment with first-line palliative chemotherapy, immunotherapy or targeted therapy.
The hypotheses: That the multimodal intervention will increase or maintain physical function levels and strength, reduce symptoms and side-effects, improve quality of life, reduce treatment-related complications and hospital admissions, and reduce risk of cancer cachexia and sarcopenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
All physical tests will be conducted by masked health care professionals.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •, participants must:
- •Be diagnosed with locally advanced or metastatic pancreatic cancer, OR locally advanced or metastatic biliary tract cancer, OR locally advanced or metastatic non-small cell lung cancer within 12 weeks.
- •Have unresectable cancer.
- •Be treated with first-line palliative chemotherapy, immunotherapy or targeted therapy at the Department of Oncology, Herlev and Gentofte Hospital.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Have the ability to speak and read Danish, and to provide a signed informed consent form.
排除标准
- •, patients with:
- •Small-cell lung cancer.
- •Any physical condition that hinder the execution of physical exercise training.
- •Documented and uncontrolled brain metastases that hinder participation in an exercise-based trial, based on the referring oncologist's assessment.
- •Dementia, psychotic disorders, or other cognitive diseases or conditions that hinder participation in a clinical exercise-based trial.
- •Unstable medical disease or history of serious or concurrent illness; any Medical condition that might be aggravated by exercise training or that cannot be controlled, including, but not restricted to congestive heart failure (NYHA class II-IV), unstable angina pectoris, implantable cardioverter defibrillator, or myocardial infarction within 6 months, based on the referring oncologist's assessment.
- •In patients with bone metastases:
- •A bone metastatic burden or location that poses a risk of injury in the performance of exercise training, as assessed by the referring oncologist.
研究组 & 干预措施
Intervention group (n=50)
Participants in the intervention group will receive usual care and the multimodal and exercise-based intervention.
干预措施: Multimodal and exercise-based intervention (Behavioral)
Control group (n=50)
Participants in the control group will receive usual care.
结局指标
主要结局
Lower body strength measured with the 30-second chair stand test
时间窗: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Number of stands a participant can complete in 30-seconds from a seated position with their arms crossed over the chest. The assessments will be conducted by a blinded physiotherapist
次要结局
- Survival(Up to 2 years)
- Symptoms of anxiety(Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks))
- Physical activity level(Change measures (baseline, and 12 weeks).)
- Adherence to counseling sessions(Up to 12 weeks)
- Recruitment rate(Up to 2 years)
- Physical performance measured with the 6-minute-walk-test(Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks))
- Upper-body strength measured with the Handgrip Strength Test(Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks))
- Symptoms of depression(Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks))
- Body mass index(Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks))
- Inflammation (inflammatory biomarkers: C-reactive protein, Interleukin 6, YKL-40)(Up to 6 months)
- Length of hospitalizations (days)(Up to 6 months)
- Adverse events(Up to 12 weeks)
- Quality of life(Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks))
- Qualitative assessment of participants' experiences(After 12 weeks)
- Adherence to exercise sessions(Up to 12 weeks)
- Physical performance measured with the 6-meter Gait Speed Test(Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks))
- Whole-body Lean body mass (LBM)(Change measures (baseline, and 12 weeks))
- Whole-body fat mass(Change measures (baseline, and 12 weeks))
- Whole-body bone mineral density(Change measures (baseline, and 12 weeks))
- Symptom burden(Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks))
- Number of participants with side-effects to oncological treatment assessed with the Common Toxicity Criteria for Adverse Events version 4(Up to 6 months)
- Number of hospital admissions(Up to 6 months)
- Causes of hospitalizations(Up to 6 months)
- Body weight(Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks))
研究者
Marta Kramer Mikkelsen
Principal Investigator
Rigshospitalet, Denmark