Patient Activation Through Counseling, Exercise and Mobilization

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pancreas Cancer, Biliary Tract Cancer, Non Small Cell Lung Cancer, Advanced Cancer

Intervention / Treatment
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* Behavioral: Multimodal and exercise-based intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria, 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 ≤2. Have the ability to speak and read Danish, and to provide a signed informed consent form. Exclusion Criteria, 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized 1:1 to the intervention group and control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group (n=50)<br>Participants in the intervention group will receive usual care and the multimodal and exercise-based intervention. | Behavioral: Multimodal and exercise-based intervention<br>* The multimodal and exercise-based intervention is comprised of: Supervised and group-based exercise two times a week (60 minutes per session). The program consists of warm-up, exercises for balance and flexibility, progressive resistance training, and stretching and relaxation. Individualized activity program based on step counts (with activity tracker). Based on each participant's starting point, preferences and motivation, an individualized program will be composed. Evaluation and goal-setting will be conducted once weekly. Nurse-led supportive and motivational counseling; each participant will be invited to two sessions of counseling (in week 1 + 6). Each session will be based on a holistic assessment of each participant's life situation. Advice and counseling will be provided based on identified problems and needs. A nutritional supplement (protein bar or drink) will be served to participants immediately after the supervised exercise session.<br>|
| No Intervention: Control group (n=50)<br>Participants in the control group will receive usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower body strength measured with the 30-second chair stand test | 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 | Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Number of participants included from eligible patients | Up to 2 years | 
| Adherence to exercise sessions | Number of exercise sessions attended out of planned sessions | Up to 12 weeks | 
| Adherence to counseling sessions | Number of counseling sessions attended out of planned sessions | Up to 12 weeks | 
| Adverse events | Cases of exercise-related injuries or events, including, but not restricted to musculoskeletal-related events, falls, fall-related injuries, bleedings, or cardiovascular events. | Up to 12 weeks | 
| Physical performance measured with the 6-minute-walk-test | 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 | Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks) | 
| Physical performance measured with the 6-meter Gait Speed Test | The assessments will be conducted by a blinded physiotherapist | Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks) | 
| Upper-body strength measured with the Handgrip Strength Test | Handgrip strength will be measured using a hand-held Jamar dynamometer. The assessments will be conducted by a blinded physiotherapist | Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks) | 
| Physical activity level | Step Counts (measured with Garmin Vivofit 3 activity tracker). | Change measures (baseline, and 12 weeks). | 
| Qualitative assessment of participants' experiences | Qualitative individual semi-structured interviews with participants from the intervention group | After 12 weeks | 
| Quality of life | Measured with the EORTC Quality of Life questionnaire (EORTC QLQ-C30) | Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks) | 
| Symptoms of depression | Measured with the patient questionnaire 'Hospital Anxiety and Depression Scale' (HADS) | Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks) | 
| Symptoms of anxiety | Measured with the 'Hospital Anxiety and Depression Scale' (HADS) patient questionnaire | Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks) | 
| Symptom burden | Measured with the 'M.D. Anderson Symptom Inventory' patient questionnaire | 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 | Data will be collected from medical charts | Up to 6 months | 
| Body weight | Weight will be measured using standard procedures (no shoes, light clothing) and will be reported in kilograms | Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks) | 
| Body mass index | Reported in kg/m^2 | Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks) | 
| Whole-body Lean body mass (LBM) | Measured with Bioimpedance and DXA scans | Change measures (baseline, and 12 weeks) | 
| Whole-body fat mass | Measured with Bioimpedance and DXA scans | Change measures (baseline, and 12 weeks) | 
| Whole-body bone mineral density | Measured with DXA scans | Change measures (baseline, and 12 weeks) | 
| Inflammation (inflammatory biomarkers: C-reactive protein, Interleukin 6, YKL-40) | Data will be collected from medical charts | Up to 6 months | 
| Number of hospital admissions | Data will be collected from medical charts | Up to 6 months | 
| Causes of hospitalizations | Data will be collected from medical charts | Up to 6 months | 
| Length of hospitalizations (days) | Data will be collected from medical charts | Up to 6 months | 
| Survival | Data will be collected from medical charts | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Older, Advanced Cancer, Resistance training, Counseling, Mobilization