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

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

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.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer; Advanced Cancer; Pancreas Cancer; Biliary Tract Cancer
• Intervention / Treatment: Behavioral: Multimodal and exercise-based intervention

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Herlev and Gentofte Hospital, Department of Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group (n=50); Participants in the intervention group will receive usual care and the multimodal and exercise-based intervention.	Behavioral: Multimodal and exercise-based intervention; 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.
No Intervention: Control group (n=50); Participants in the control group will receive usual care.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital
• Collaborators: Rigshospitalet, Denmark; University of Copenhagen
• Investigators: Principal Investigator: Marta Kramer Mikkelsen, Rigshospitalet, Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2018
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Exercise; Counseling; Advanced Cancer; Resistance training; Older; Mobilization
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Biliary Tract Diseases; Pancreatic Diseases; Lung Neoplasms; Pancreatic Neoplasms; Biliary Tract Neoplasms
• Other Study ID Numbers: PACE-Mobil-PBL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No