NCT03411200

Patient Activation Through Counseling, Exercise and Mobilization

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Herlev and Gentofte Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2018-04-04
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2018-01-26
• Last updated: 2020-07-14

Locations

1 site across 1 country: Denmark