Patient Activation Through Counseling, Exercise and Mobilization
- Conditions
- Advanced CancerBiliary Tract CancerPancreas CancerNon Small Cell Lung Cancer
- Interventions
- Behavioral: Multimodal and exercise-based intervention
- Registration Number
- NCT03411200
- Lead Sponsor
- Herlev and Gentofte Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group (n=50) Multimodal and exercise-based intervention Participants in the intervention group will receive usual care and the multimodal and exercise-based intervention.
- Primary Outcome Measures
Name Time Method Lower body strength measured with the 30-second chair stand test 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
- Secondary Outcome Measures
Name Time Method Symptoms of anxiety Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks) Measured with the 'Hospital Anxiety and Depression Scale' (HADS) patient questionnaire
Physical activity level Change measures (baseline, and 12 weeks). Step Counts (measured with Garmin Vivofit 3 activity tracker).
Adherence to counseling sessions Up to 12 weeks Number of counseling sessions attended out of planned sessions
Recruitment rate Up to 2 years Number of participants included from eligible patients
Physical performance measured with the 6-minute-walk-test Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks) The distance (measured in meters) a participant is able to walk over a total of six minutes on a hard flat surface. The assessments will be conducted by a blinded physiotherapist
Upper-body strength measured with the Handgrip Strength Test Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks) Handgrip strength will be measured using a hand-held Jamar dynamometer. The assessments will be conducted by a blinded physiotherapist
Symptoms of depression Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks) Measured with the patient questionnaire 'Hospital Anxiety and Depression Scale' (HADS)
Body mass index Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks) Reported in kg/m\^2
Inflammation (inflammatory biomarkers: C-reactive protein, Interleukin 6, YKL-40) Up to 6 months Data will be collected from medical charts
Length of hospitalizations (days) Up to 6 months Data will be collected from medical charts
Adverse events Up to 12 weeks Cases of exercise-related injuries or events, including, but not restricted to musculoskeletal-related events, falls, fall-related injuries, bleedings, or cardiovascular events.
Quality of life Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks) Measured with the EORTC Quality of Life questionnaire (EORTC QLQ-C30)
Qualitative assessment of participants' experiences After 12 weeks Qualitative individual semi-structured interviews with participants from the intervention group
Adherence to exercise sessions Up to 12 weeks Number of exercise sessions attended out of planned sessions
Physical performance measured with the 6-meter Gait Speed Test Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks) The assessments will be conducted by a blinded physiotherapist
Whole-body Lean body mass (LBM) Change measures (baseline, and 12 weeks) Measured with Bioimpedance and DXA scans
Whole-body fat mass Change measures (baseline, and 12 weeks) Measured with Bioimpedance and DXA scans
Whole-body bone mineral density Change measures (baseline, and 12 weeks) Measured with DXA scans
Symptom burden Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks) Measured with the 'M.D. Anderson Symptom Inventory' patient questionnaire
Number of participants with side-effects to oncological treatment assessed with the Common Toxicity Criteria for Adverse Events version 4 Up to 6 months Data will be collected from medical charts
Number of hospital admissions Up to 6 months Data will be collected from medical charts
Causes of hospitalizations Up to 6 months Data will be collected from medical charts
Body weight Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks) Weight will be measured using standard procedures (no shoes, light clothing) and will be reported in kilograms
Survival Up to 2 years Data will be collected from medical charts
Trial Locations
- Locations (1)
Herlev and Gentofte Hospital, Department of Oncology
🇩🇰Herlev, Denmark