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Patient Activation Through Counseling, Exercise and Mobilization (PACE-Mobil)

Primary Purpose

Pancreas Cancer, Biliary Tract Cancer, Non Small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Multimodal and exercise-based intervention
Sponsored by
Herlev and Gentofte Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pancreas Cancer focused on measuring Older, Advanced Cancer, Exercise, Resistance training, Counseling, Mobilization

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Herlev and Gentofte Hospital, Department of Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group (n=50)

Control group (n=50)

Arm Description

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

Participants in the control group will receive usual care.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Recruitment rate
Number of participants included from eligible patients
Adherence to exercise sessions
Number of exercise sessions attended out of planned sessions
Adherence to counseling sessions
Number of counseling sessions attended out of planned sessions
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.
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
Physical performance measured with the 6-meter Gait Speed Test
The assessments will be conducted by a blinded physiotherapist
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
Physical activity level
Step Counts (measured with Garmin Vivofit 3 activity tracker).
Qualitative assessment of participants' experiences
Qualitative individual semi-structured interviews with participants from the intervention group
Quality of life
Measured with the EORTC Quality of Life questionnaire (EORTC QLQ-C30)
Symptoms of depression
Measured with the patient questionnaire 'Hospital Anxiety and Depression Scale' (HADS)
Symptoms of anxiety
Measured with the 'Hospital Anxiety and Depression Scale' (HADS) patient questionnaire
Symptom burden
Measured with the 'M.D. Anderson Symptom Inventory' patient questionnaire
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
Body weight
Weight will be measured using standard procedures (no shoes, light clothing) and will be reported in kilograms
Body mass index
Reported in kg/m^2
Whole-body Lean body mass (LBM)
Measured with Bioimpedance and DXA scans
Whole-body fat mass
Measured with Bioimpedance and DXA scans
Whole-body bone mineral density
Measured with DXA scans
Inflammation (inflammatory biomarkers: C-reactive protein, Interleukin 6, YKL-40)
Data will be collected from medical charts
Number of hospital admissions
Data will be collected from medical charts
Causes of hospitalizations
Data will be collected from medical charts
Length of hospitalizations (days)
Data will be collected from medical charts
Survival
Data will be collected from medical charts

Full Information

First Posted
January 10, 2018
Last Updated
July 13, 2020
Sponsor
Herlev and Gentofte Hospital
Collaborators
Rigshospitalet, Denmark, University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT03411200
Brief Title
Patient Activation Through Counseling, Exercise and Mobilization
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 4, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev and Gentofte Hospital
Collaborators
Rigshospitalet, Denmark, University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer, Biliary Tract Cancer, Non Small Cell Lung Cancer, Advanced Cancer
Keywords
Older, Advanced Cancer, Exercise, Resistance training, Counseling, Mobilization

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized 1:1 to the intervention group and control group.
Masking
Outcomes Assessor
Masking Description
All physical tests will be conducted by masked health care professionals.
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group (n=50)
Arm Type
Experimental
Arm Description
Participants in the intervention group will receive usual care and the multimodal and exercise-based intervention.
Arm Title
Control group (n=50)
Arm Type
No Intervention
Arm Description
Participants in the control group will receive usual care.
Intervention Type
Behavioral
Intervention Name(s)
Multimodal and exercise-based intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lower body strength measured with the 30-second chair stand test
Description
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
Time Frame
Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Secondary Outcome Measure Information:
Title
Recruitment rate
Description
Number of participants included from eligible patients
Time Frame
Up to 2 years
Title
Adherence to exercise sessions
Description
Number of exercise sessions attended out of planned sessions
Time Frame
Up to 12 weeks
Title
Adherence to counseling sessions
Description
Number of counseling sessions attended out of planned sessions
Time Frame
Up to 12 weeks
Title
Adverse events
Description
Cases of exercise-related injuries or events, including, but not restricted to musculoskeletal-related events, falls, fall-related injuries, bleedings, or cardiovascular events.
Time Frame
Up to 12 weeks
Title
Physical performance measured with the 6-minute-walk-test
Description
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
Time Frame
Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Title
Physical performance measured with the 6-meter Gait Speed Test
Description
The assessments will be conducted by a blinded physiotherapist
Time Frame
Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Title
Upper-body strength measured with the Handgrip Strength Test
Description
Handgrip strength will be measured using a hand-held Jamar dynamometer. The assessments will be conducted by a blinded physiotherapist
Time Frame
Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Title
Physical activity level
Description
Step Counts (measured with Garmin Vivofit 3 activity tracker).
Time Frame
Change measures (baseline, and 12 weeks).
Title
Qualitative assessment of participants' experiences
Description
Qualitative individual semi-structured interviews with participants from the intervention group
Time Frame
After 12 weeks
Title
Quality of life
Description
Measured with the EORTC Quality of Life questionnaire (EORTC QLQ-C30)
Time Frame
Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Title
Symptoms of depression
Description
Measured with the patient questionnaire 'Hospital Anxiety and Depression Scale' (HADS)
Time Frame
Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Title
Symptoms of anxiety
Description
Measured with the 'Hospital Anxiety and Depression Scale' (HADS) patient questionnaire
Time Frame
Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Title
Symptom burden
Description
Measured with the 'M.D. Anderson Symptom Inventory' patient questionnaire
Time Frame
Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Title
Number of participants with side-effects to oncological treatment assessed with the Common Toxicity Criteria for Adverse Events version 4
Description
Data will be collected from medical charts
Time Frame
Up to 6 months
Title
Body weight
Description
Weight will be measured using standard procedures (no shoes, light clothing) and will be reported in kilograms
Time Frame
Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Title
Body mass index
Description
Reported in kg/m^2
Time Frame
Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Title
Whole-body Lean body mass (LBM)
Description
Measured with Bioimpedance and DXA scans
Time Frame
Change measures (baseline, and 12 weeks)
Title
Whole-body fat mass
Description
Measured with Bioimpedance and DXA scans
Time Frame
Change measures (baseline, and 12 weeks)
Title
Whole-body bone mineral density
Description
Measured with DXA scans
Time Frame
Change measures (baseline, and 12 weeks)
Title
Inflammation (inflammatory biomarkers: C-reactive protein, Interleukin 6, YKL-40)
Description
Data will be collected from medical charts
Time Frame
Up to 6 months
Title
Number of hospital admissions
Description
Data will be collected from medical charts
Time Frame
Up to 6 months
Title
Causes of hospitalizations
Description
Data will be collected from medical charts
Time Frame
Up to 6 months
Title
Length of hospitalizations (days)
Description
Data will be collected from medical charts
Time Frame
Up to 6 months
Title
Survival
Description
Data will be collected from medical charts
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Kramer Mikkelsen
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev and Gentofte Hospital, Department of Oncology
City
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30261853
Citation
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.
Results Reference
derived

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Patient Activation Through Counseling, Exercise and Mobilization

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