Patient Activation Through Counseling, Exercise and Mobilization

NCT ID: NCT03411200

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-04
• Study Completion Date: 2020-07-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention group (n=50)

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

Group Type: EXPERIMENTAL

Multimodal and exercise-based intervention

Intervention Type: 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.

Control group (n=50)

Participants in the control group will receive usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multimodal and exercise-based intervention

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

Herlev and Gentofte Hospital

OTHER

Sponsor Role: lead

Responsible Party

Marta Kramer Mikkelsen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marta Kramer Mikkelsen

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Herlev and Gentofte Hospital, Department of Oncology

Herlev, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 30261853 (View on PubMed)

Other Identifiers

PACE-Mobil-PBL

Identifier Type: -

Identifier Source: org_study_id