Patient Activation Through Counseling, Exercise and Mobilization

Non Small Cell Lung Cancer Clinical Trial

— PACE-Mobil  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411200
• Other study ID #: PACE-Mobil-PBL
• Status: Completed
• Phase: N/A
• Start date: April 4, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: Herlev and Gentofte Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Lung Neoplasms
• Non Small Cell Lung Cancer
• Pancreas Cancer
• Pancreatic Neoplasms

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.

Locations

Country	Name	City	State
Denmark	Herlev and Gentofte Hospital, Department of Oncology	Herlev

Sponsors (3)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital	Rigshospitalet, Denmark, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recruitment rate	Number of participants included from eligible patients	Up to 2 years
Secondary	Adherence to exercise sessions	Number of exercise sessions attended out of planned sessions	Up to 12 weeks
Secondary	Adherence to counseling sessions	Number of counseling sessions attended out of planned sessions	Up to 12 weeks
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Physical activity level	Step Counts (measured with Garmin Vivofit 3 activity tracker).	Change measures (baseline, and 12 weeks).
Secondary	Qualitative assessment of participants' experiences	Qualitative individual semi-structured interviews with participants from the intervention group	After 12 weeks
Secondary	Quality of life	Measured with the EORTC Quality of Life questionnaire (EORTC QLQ-C30)	Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Secondary	Symptoms of depression	Measured with the patient questionnaire 'Hospital Anxiety and Depression Scale' (HADS)	Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Secondary	Symptoms of anxiety	Measured with the 'Hospital Anxiety and Depression Scale' (HADS) patient questionnaire	Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Secondary	Symptom burden	Measured with the 'M.D. Anderson Symptom Inventory' patient questionnaire	Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Secondary	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
Secondary	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)
Secondary	Body mass index	Reported in kg/m^2	Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Secondary	Whole-body Lean body mass (LBM)	Measured with Bioimpedance and DXA scans	Change measures (baseline, and 12 weeks)
Secondary	Whole-body fat mass	Measured with Bioimpedance and DXA scans	Change measures (baseline, and 12 weeks)
Secondary	Whole-body bone mineral density	Measured with DXA scans	Change measures (baseline, and 12 weeks)
Secondary	Inflammation (inflammatory biomarkers: C-reactive protein, Interleukin 6, YKL-40)	Data will be collected from medical charts	Up to 6 months
Secondary	Number of hospital admissions	Data will be collected from medical charts	Up to 6 months
Secondary	Causes of hospitalizations	Data will be collected from medical charts	Up to 6 months
Secondary	Length of hospitalizations (days)	Data will be collected from medical charts	Up to 6 months
Secondary	Survival	Data will be collected from medical charts	Up to 2 years