Herlev and Gentofte Hospital, Department of Oncology
Herlev, 2730, Denmark
NCT Number: NCT03411200
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.
Looking for future studies?
Notify Me65 year and older
All sexes
Interventional
Not applicable
Herlev, 2730, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
, participants must:
Exclusion criteria
, patients with:
In patients with bone metastases:
The multimodal and exercise-based intervention is comprised of:
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
Time frame: Up to 2 years
Number of participants included from eligible patients
Time frame: Up to 12 weeks
Number of exercise sessions attended out of planned sessions
Time frame: Up to 12 weeks
Number of counseling sessions attended out of planned sessions
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.
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
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
The assessments will be conducted by a blinded physiotherapist
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
Time frame: Change measures (baseline, and 12 weeks).
Step Counts (measured with Garmin Vivofit 3 activity tracker).
Time frame: After 12 weeks
Qualitative individual semi-structured interviews with participants from the intervention group
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Measured with the EORTC Quality of Life questionnaire (EORTC QLQ-C30)
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Measured with the patient questionnaire 'Hospital Anxiety and Depression Scale' (HADS)
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Measured with the 'Hospital Anxiety and Depression Scale' (HADS) patient questionnaire
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Measured with the 'M.D. Anderson Symptom Inventory' patient questionnaire
Time frame: Up to 6 months
Data will be collected from medical charts
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
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Reported in kg/m^2
Time frame: Change measures (baseline, and 12 weeks)
Measured with Bioimpedance and DXA scans
Time frame: Change measures (baseline, and 12 weeks)
Measured with Bioimpedance and DXA scans
Time frame: Change measures (baseline, and 12 weeks)
Measured with DXA scans
Time frame: Up to 6 months
Data will be collected from medical charts
Time frame: Up to 6 months
Data will be collected from medical charts
Time frame: Up to 6 months
Data will be collected from medical charts
Time frame: Up to 6 months
Data will be collected from medical charts
Time frame: Up to 2 years
Data will be collected from medical charts
Herlev and Gentofte Hospital
Other
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
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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