Patient Activation Through Counseling, Exercise and Mobilization

Not Applicable

Completed

• Conditions: Advanced Cancer; Biliary Tract Cancer; Pancreas Cancer; Non Small Cell Lung Cancer

• Registration Number: NCT03411200
• Lead Sponsor: Herlev and Gentofte Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-26
• Study Start: 2018-04-04
• Status Verified: 2020-07
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lower body strength measured with the 30-second chair stand test	Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)	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

Secondary Outcome Measures

Name	Time	Method
Symptoms of anxiety	Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)	Measured with the 'Hospital Anxiety and Depression Scale' (HADS) patient questionnaire
Physical activity level	Change measures (baseline, and 12 weeks).	Step Counts (measured with Garmin Vivofit 3 activity tracker).
Adherence to counseling sessions	Up to 12 weeks	Number of counseling sessions attended out of planned sessions
Recruitment rate	Up to 2 years	Number of participants included from eligible patients
Physical performance measured with the 6-minute-walk-test	Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)	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
Upper-body strength measured with the Handgrip Strength Test	Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)	Handgrip strength will be measured using a hand-held Jamar dynamometer. The assessments will be conducted by a blinded physiotherapist
Symptoms of depression	Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)	Measured with the patient questionnaire 'Hospital Anxiety and Depression Scale' (HADS)
Body mass index	Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)	Reported in kg/m\^2
Inflammation (inflammatory biomarkers: C-reactive protein, Interleukin 6, YKL-40)	Up to 6 months	Data will be collected from medical charts
Length of hospitalizations (days)	Up to 6 months	Data will be collected from medical charts
Adverse events	Up to 12 weeks	Cases of exercise-related injuries or events, including, but not restricted to musculoskeletal-related events, falls, fall-related injuries, bleedings, or cardiovascular events.
Quality of life	Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)	Measured with the EORTC Quality of Life questionnaire (EORTC QLQ-C30)
Qualitative assessment of participants' experiences	After 12 weeks	Qualitative individual semi-structured interviews with participants from the intervention group
Adherence to exercise sessions	Up to 12 weeks	Number of exercise sessions attended out of planned sessions
Physical performance measured with the 6-meter Gait Speed Test	Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)	The assessments will be conducted by a blinded physiotherapist
Whole-body Lean body mass (LBM)	Change measures (baseline, and 12 weeks)	Measured with Bioimpedance and DXA scans
Whole-body fat mass	Change measures (baseline, and 12 weeks)	Measured with Bioimpedance and DXA scans
Whole-body bone mineral density	Change measures (baseline, and 12 weeks)	Measured with DXA scans
Symptom burden	Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)	Measured with the 'M.D. Anderson Symptom Inventory' patient questionnaire
Survival	Up to 2 years	Data will be collected from medical charts
Number of participants with side-effects to oncological treatment assessed with the Common Toxicity Criteria for Adverse Events version 4	Up to 6 months	Data will be collected from medical charts
Number of hospital admissions	Up to 6 months	Data will be collected from medical charts
Causes of hospitalizations	Up to 6 months	Data will be collected from medical charts
Body weight	Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)	Weight will be measured using standard procedures (no shoes, light clothing) and will be reported in kilograms

Trial Locations

Locations (1)

Herlev and Gentofte Hospital, Department of Oncology; 🇩🇰 Herlev, Denmark