Clinical trial · Interventional
Patient Activation Through Counseling, Exercise and Mobilization
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimodal and exercise-based intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group (n=50)
- description
- Participants in the intervention group will receive usual care and the multimodal and exercise-based intervention.
- interventionNames
- Behavioral: Multimodal and exercise-based intervention
- type
- NO_INTERVENTION
- label
- Control group (n=50)
- description
- Participants in the control group will receive usual care.
Primary outcomes (1)
- measure
- Lower body strength measured with the 30-second chair stand test
- timeFrame
- Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDMikkelsen 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. PMID 30261853