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Completed

NCT Number: NCT03411200

Patient Activation Through Counseling, Exercise and Mobilization

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multimodal and exercise-based intervention

Behavioral

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 outcomes

  1. Lower body strength measured with the 30-second chair stand test

    Time frame: 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 outcomes

  1. Recruitment rate

    Time frame: Up to 2 years

    Number of participants included from eligible patients

  2. Adherence to exercise sessions

    Time frame: Up to 12 weeks

    Number of exercise sessions attended out of planned sessions

  3. Adherence to counseling sessions

    Time frame: Up to 12 weeks

    Number of counseling sessions attended out of planned sessions

  4. Adverse events

    Time frame: 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.

  5. Physical performance measured with the 6-minute-walk-test

    Time frame: 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

  6. Physical performance measured with the 6-meter Gait Speed Test

    Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)

    The assessments will be conducted by a blinded physiotherapist

  7. Upper-body strength measured with the Handgrip Strength Test

    Time frame: 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

  8. Physical activity level

    Time frame: Change measures (baseline, and 12 weeks).

    Step Counts (measured with Garmin Vivofit 3 activity tracker).

  9. Qualitative assessment of participants' experiences

    Time frame: After 12 weeks

    Qualitative individual semi-structured interviews with participants from the intervention group

  10. Quality of life

    Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)

    Measured with the EORTC Quality of Life questionnaire (EORTC QLQ-C30)

  11. Symptoms of depression

    Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)

    Measured with the patient questionnaire 'Hospital Anxiety and Depression Scale' (HADS)

  12. Symptoms of anxiety

    Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)

    Measured with the 'Hospital Anxiety and Depression Scale' (HADS) patient questionnaire

  13. Symptom burden

    Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)

    Measured with the 'M.D. Anderson Symptom Inventory' patient questionnaire

  14. Number of participants with side-effects to oncological treatment assessed with the Common Toxicity Criteria for Adverse Events version 4

    Time frame: Up to 6 months

    Data will be collected from medical charts

  15. Body weight

    Time frame: 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

  16. Body mass index

    Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)

    Reported in kg/m^2

  17. Whole-body Lean body mass (LBM)

    Time frame: Change measures (baseline, and 12 weeks)

    Measured with Bioimpedance and DXA scans

  18. Whole-body fat mass

    Time frame: Change measures (baseline, and 12 weeks)

    Measured with Bioimpedance and DXA scans

  19. Whole-body bone mineral density

    Time frame: Change measures (baseline, and 12 weeks)

    Measured with DXA scans

  20. Inflammation (inflammatory biomarkers: C-reactive protein, Interleukin 6, YKL-40)

    Time frame: Up to 6 months

    Data will be collected from medical charts

  21. Number of hospital admissions

    Time frame: Up to 6 months

    Data will be collected from medical charts

  22. Causes of hospitalizations

    Time frame: Up to 6 months

    Data will be collected from medical charts

  23. Length of hospitalizations (days)

    Time frame: Up to 6 months

    Data will be collected from medical charts

  24. Survival

    Time frame: Up to 2 years

    Data will be collected from medical charts

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Collaborators

  • Rigshospitalet, Denmark
  • University of Copenhagen

Registry information

Official study 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

Acronym: PACE-Mobil

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2018
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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