Pancreas CancerPACE-MobilNCT03411200
Patient Activation Through Counseling, Exercise and Mobilization
A study testing Multimodal and exercise-based intervention in people with Pancreas Cancer and Biliary Tract Cancer, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pancreas Cancer, Biliary Tract Cancer, Non Small Cell Lung Cancer
- What is being tested?
- Multimodal and exercise-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Apr 2018to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Herlev and Gentofte Hospital, Department of Oncology
Herlev, 2730
About this study
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
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.
- Being tested
- Multimodal and exercise-based intervention
- Keywords
- Older, Advanced Cancer, Exercise, Resistance training, Counseling, Mobilization
- Medical subject headings
- Pancreatic Neoplasms, Biliary Tract Neoplasms, Carcinoma, Non-Small-Cell Lung, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal and exercise-based interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (n=50) | Experimental | Participants in the intervention group will receive usual care and the multimodal and exercise-based intervention. Receives: Behavioral: Multimodal and exercise-based intervention |
| Control group (n=50) | No intervention | Participants in the control group will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Secondary outcomes (24)
Recruitment rate
Number of participants included from eligible patients
Measured: Up to 2 years
Adherence to exercise sessions
Number of exercise sessions attended out of planned sessions
Measured: Up to 12 weeks
Adherence to counseling sessions
Number of counseling sessions attended out of planned sessions
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
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
Measured: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Physical performance measured with the 6-meter Gait Speed Test
The assessments will be conducted by a blinded physiotherapist
Measured: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
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
Measured: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Physical activity level
Step Counts (measured with Garmin Vivofit 3 activity tracker).
Measured: Change measures (baseline, and 12 weeks).
Qualitative assessment of participants' experiences
Qualitative individual semi-structured interviews with participants from the intervention group
Measured: After 12 weeks
Quality of life
Measured with the EORTC Quality of Life questionnaire (EORTC QLQ-C30)
Measured: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Symptoms of depression
Measured with the patient questionnaire 'Hospital Anxiety and Depression Scale' (HADS)
Measured: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Symptoms of anxiety
Measured with the 'Hospital Anxiety and Depression Scale' (HADS) patient questionnaire
Measured: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Symptom burden
Measured with the 'M.D. Anderson Symptom Inventory' patient questionnaire
Measured: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
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
Measured: Up to 6 months
Body weight
Weight will be measured using standard procedures (no shoes, light clothing) and will be reported in kilograms
Measured: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Body mass index
Reported in kg/m^2
Measured: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Whole-body Lean body mass (LBM)
Measured with Bioimpedance and DXA scans
Measured: Change measures (baseline, and 12 weeks)
Whole-body fat mass
Measured with Bioimpedance and DXA scans
Measured: Change measures (baseline, and 12 weeks)
Whole-body bone mineral density
Measured with DXA scans
Measured: Change measures (baseline, and 12 weeks)
Inflammation (inflammatory biomarkers: C-reactive protein, Interleukin 6, YKL-40)
Data will be collected from medical charts
Measured: Up to 6 months
Number of hospital admissions
Data will be collected from medical charts
Measured: Up to 6 months
Causes of hospitalizations
Data will be collected from medical charts
Measured: Up to 6 months
Length of hospitalizations (days)
Data will be collected from medical charts
Measured: Up to 6 months
Survival
Data will be collected from medical charts
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start4 Apr 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to the intervention group and control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Kramer Mikkelsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Marta Kramer Mikkelsen, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411200
- Sponsor's protocol ID
- PACE-Mobil-PBL
- Acronym
- PACE-Mobil
- Status last verified
- Jul 2020
- First submitted
- 10 Jan 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30261853
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03411200
- Acronym / sponsor ID
- PACE-Mobil / PACE-Mobil-PBL
- Keywords
- Older, Advanced Cancer, Exercise, Resistance training, Counseling, Mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, University of Copenhagen
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to the intervention group and control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group (n=50) | Experimental | Behavioral: Multimodal and exercise-based interventionParticipants in the intervention group will receive usual care and the multimodal and exercise-based intervention. |
| Control group (n=50) | No intervention | –Participants in the control group will receive usual care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal and exercise-based interventionThe multimodal and exercise-based intervention is comprised of: 1. 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. 2. 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. 3. 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. 4. A nutritional supplement (protein bar or drink) will be served to participants immediately after the supervised exercise session. | Behavioural | Intervention group (n=50) |
Primary outcome
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
24 secondary outcomes
Recruitment rate
Time frame: Up to 2 years
Adherence to exercise sessions
Time frame: Up to 12 weeks
Adherence to counseling sessions
Time frame: Up to 12 weeks
Adverse events
Time frame: Up to 12 weeks
Physical performance measured with the 6-minute-walk-test
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Physical performance measured with the 6-meter Gait Speed Test
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Upper-body strength measured with the Handgrip Strength Test
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Physical activity level
Time frame: Change measures (baseline, and 12 weeks).
Qualitative assessment of participants' experiences
Time frame: After 12 weeks
Quality of life
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Symptoms of depression
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Symptoms of anxiety
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Symptom burden
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
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
Body weight
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Body mass index
Time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)
Whole-body Lean body mass (LBM)
Time frame: Change measures (baseline, and 12 weeks)
Whole-body fat mass
Time frame: Change measures (baseline, and 12 weeks)
Whole-body bone mineral density
Time frame: Change measures (baseline, and 12 weeks)
Inflammation (inflammatory biomarkers: C-reactive protein, Interleukin 6, YKL-40)
Time frame: Up to 6 months
Number of hospital admissions
Time frame: Up to 6 months
Causes of hospitalizations
Time frame: Up to 6 months
Length of hospitalizations (days)
Time frame: Up to 6 months
Survival
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Derived from this study: PubMed 30261853Mikkelsen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Kramer Mikkelsen principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal and exercise-based intervention in people with Pancreas Cancer and Biliary Tract Cancer, run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower body strength measured with the 30-second chair stand test (time frame: Change measures (baseline, 6 weeks, 12 weeks, and 16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03411200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020; AzTrials last refreshed its copy on 2 Nov 2026.