Clinical trial NCT03411200: Patient Activation Through Counseling, Exercise and Mobilization
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreas Cancer
Biliary Tract Cancer
Non Small Cell Lung Cancer
Advanced Cancer
Keywords: Older
Advanced Cancer
Exercise
Resistance training
Counseling
Mobilization
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: University of Copenhagen
First posted: 2018-01-26
Enrollment: 99
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1 to the intervention group and control group.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Lower body strength measured with the 30-second chair stand test
timeFrame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Secondary outcomes:
measure: Recruitment rate
timeFrame: Up to 2 years
measure: Adherence to exercise sessions
timeFrame: Up to 12 weeks
measure: Adherence to counseling sessions
timeFrame: Up to 12 weeks
measure: Adverse events
timeFrame: Up to 12 weeks
measure: Physical performance measured with the 6-minute-walk-test
timeFrame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
measure: Physical performance measured with the 6-meter Gait Speed Test
timeFrame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
measure: Upper-body strength measured with the Handgrip Strength Test
timeFrame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
measure: Physical activity level
timeFrame: Change measures (baseline, and 12 weeks).
measure: Qualitative assessment of participants' experiences
timeFrame: After 12 weeks
measure: Quality of life
timeFrame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
measure: Symptoms of depression
timeFrame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
measure: Symptoms of anxiety
timeFrame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
measure: Symptom burden
timeFrame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
measure: Number of participants with side-effects to oncological treatment assessed with the Common Toxicity Criteria for Adverse Events version 4
timeFrame: Up to 6 months
measure: Body weight
timeFrame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
measure: Body mass index
timeFrame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
measure: Whole-body Lean body mass (LBM)
timeFrame: Change measures (baseline, and 12 weeks)
measure: Whole-body fat mass
timeFrame: Change measures (baseline, and 12 weeks)
measure: Whole-body bone mineral density
timeFrame: Change measures (baseline, and 12 weeks)
measure: Inflammation (inflammatory biomarkers: C-reactive protein, Interleukin 6, YKL-40)
timeFrame: Up to 6 months
measure: Number of hospital admissions
timeFrame: Up to 6 months
measure: Causes of hospitalizations
timeFrame: Up to 6 months
measure: Length of hospitalizations (days)
timeFrame: Up to 6 months
measure: Survival
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev and Gentofte Hospital, Department of Oncology
Study officials:
affiliation: Rigshospitalet, Denmark
name: Marta Kramer Mikkelsen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.