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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| University of Copenhagen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group (n=50) | Experimental | Participants in the intervention group will receive usual care and the multimodal and exercise-based intervention. |
|
| Control group (n=50) | No Intervention | Participants in the control group will receive usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal and exercise-based intervention | Behavioral | The multimodal and exercise-based intervention is comprised of:
|
| 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) |
| 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 |
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Inclusion Criteria, participants must:
Exclusion Criteria, patients with:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Marta Kramer Mikkelsen | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev and Gentofte Hospital, Department of Oncology | Herlev | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30261853 | Derived | Mikkelsen MK, Lund CM, Vinther A, Tolver A, Ragle AM, Johansen JS, Chen I, Engell-Noerregaard L, Larsen FO, Zerahn B, Nielsen DL, Jarden M. Engaging the older cancer patient; Patient Activation through Counseling, Exercise and Mobilization - Pancreatic, Biliary tract and Lung cancer (PACE-Mobil-PBL) - study protocol of a randomized controlled trial. BMC Cancer. 2018 Sep 27;18(1):934. doi: 10.1186/s12885-018-4835-2. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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Participants will be randomized 1:1 to the intervention group and control group.
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All physical tests will be conducted by masked health care professionals.
|
| 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 |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001660 | Biliary Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |