Patient Activation Through Counseling, Exercise and Mobilization

NCT03411200 | Completed

• 1 other identifier: PACE-Mobil-PBL
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Older; Advanced Cancer; Exercise; Resistance training; Counseling; Mobilization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• Recruitment rate

  Up to 2 years

• Adherence to exercise sessions

  Up to 12 weeks

• Adherence to counseling sessions

  Up to 12 weeks

• Adverse events

  Up to 12 weeks

• Physical performance measured with the 6-minute-walk-test

  Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)

Study Arms (2)

Intervention group (n=50)

EXPERIMENTAL

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

Behavioral: Multimodal and exercise-based intervention

Control group (n=50)

NO INTERVENTION

Participants in the control group will receive usual care.

Interventions

Multimodal and exercise-based intervention BEHAVIORAL

The multimodal and exercise-based intervention is comprised of: 1. 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. 2. 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. 3. 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. 4. A nutritional supplement (protein bar or drink) will be served to participants immediately after the supervised exercise session.

Intervention group (n=50)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead
• Rigshospitalet, Denmark: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Herlev and Gentofte Hospital, Department of Oncology

Herlev, 2730, Denmark

Location

Related Publications (1)

• 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.

  PMID: 30261853 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Biliary Tract Neoplasms; Carcinoma, Non-Small-Cell Lung; Motor Activity

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Officials

• Marta Kramer Mikkelsen

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All physical tests will be conducted by masked health care professionals.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized 1:1 to the intervention group and control group.

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 26, 2018
• Study Start: April 4, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

DK (1)