Patient Activation Through Counseling, Exercise and Mobilization (PACE-Mobil)

Herlev and Gentofte Hospital

Status: Completed

Conditions: Advanced Cancer; Biliary Tract Cancer; Pancreas Cancer; Non Small Cell Lung Cancer

Treatments: Behavioral: Multimodal and exercise-based intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03411200

PACE-Mobil-PBL

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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99 participants in 2 patient groups

Intervention group (n=50)

Experimental group

Description:

Participants in the intervention group will receive usual care and the multimodal and exercise-based intervention.

Treatment:

Behavioral: Multimodal and exercise-based intervention

Control group (n=50)

No Intervention group

Description:

Participants in the control group will receive usual care.