Evidence map›Paper›PMID 30261853›Full record

ArticleBMC cancer2018

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.

Marta Kramer Mikkelsen, Cecilia Margareta Lund, Anders Vinther, Anders Tolver, Anne-Mette Ragle, Julia Sidenius Johansen, Inna Chen, Lotte Engell-Noerregaard, Finn Ole Larsen, Bo Zerahn and 2 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03411200 (Engaging the Older Cancer Patient; Patient Activation Through Counseling, Exercise and Mobilization - Pancreatic, Biliary Tract, and Lung Cancer), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03411200 nacompletednot on this map

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

TypeinterventionalSponsorHerlev and Gentofte HospitalRan2018 to 2020Enrolled99ConditionsPancreas Cancer, Biliary Tract Cancer, Non Small Cell Lung Cancer, Advanced CancerArmsMultimodal and exercise-based intervention
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  6. Review
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  9. A review of physical activity in pancreatic ductal adenocarcinoma: Epidemiology, intervention, animal models, and clinical trials.Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.] · 2022
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Marta Kramer MikkelsenDepartment of Oncology and Hematology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark. marta.kramer.mikkelsen.02@regionh.dk.ORCID http://orcid.org/0000-0003-2081-5293
Cecilia Margareta LundDepartment of Oncology, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev Ringvej 75, 2730, Herlev, Denmark.
Anders VintherDepartment of Rehabilitation, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev Ringvej 75, 2730, Herlev, Denmark.
Anders TolverData Science Laboratory, Department of Mathematical Sciences, University of Copenhagen, 2100 Copenhagen Ø, Denmark.
Anne-Mette RagleDepartment of Rehabilitation, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev Ringvej 75, 2730, Herlev, Denmark.
Julia Sidenius JohansenDepartment of Oncology, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev Ringvej 75, 2730, Herlev, Denmark.
Inna ChenDepartment of Oncology, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev Ringvej 75, 2730, Herlev, Denmark.
Lotte Engell-NoerregaardDepartment of Oncology, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev Ringvej 75, 2730, Herlev, Denmark.
Finn Ole LarsenDepartment of Oncology, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev Ringvej 75, 2730, Herlev, Denmark.
Bo ZerahnDepartment of Clinical Physiology and Nuclear Medicine, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev Ringvej 75, 2730, Herlev, Denmark.
Dorte Lisbet NielsenDepartment of Oncology, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev Ringvej 75, 2730, Herlev, Denmark.
Mary JardenDepartment of Oncology and Hematology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark.

Funding

Novo Nordisk Fonden NNF16OC0022338Novo Nordisk Fonden (DK) NNF17OC0029756
6 · The paper itself

Abstract

backgroundSeveral intervention studies have demonstrated that exercise training has beneficial effects among cancer patients. However, older cancer patients are underrepresented in clinical trials, and only few exercise-based studies have focused specifically on older patients with cancer. In particular, research investigating the effects of exercise training among older patients with advanced cancer is lacking. The purpose of the current study is to investigate the effect of a 12-week multimodal and exercise-based intervention among older patients (≥65 years) with advanced pancreatic, biliary tract or lung cancer, who are treated with first-line palliative chemotherapy, immunotherapy or targeted therapy.

methodsPACE-Mobil-PBL is a two-armed randomized controlled trial. Participants will be randomized 1:1 to an intervention group (N = 50) or a control group (N = 50). Participants in the intervention group will receive standard oncological treatment and a 12-week multimodal intervention, comprised of: (I) supervised exercise training, twice weekly in the hospital setting, (II) home-based walking with step counts and goal-setting, (III) supportive and motivational nurse-led counseling, and (IV) protein supplement after each supervised training session. Participants in the control group will receive standard oncological treatment. The primary outcome is physical function measured by the 30-s chair stand test. Secondary outcomes include measures of feasibility, activity level, physical capacity and strength, symptom burden, quality of life, toxicity to treatment, dose reductions, inflammatory biomarkers, body weight and composition, hospitalizations and survival. Assessments will be conducted at baseline, and after 6, 12 and 16 weeks. DISCUSSION: The current study is one of the first to investigate the effect of an exercise-based intervention specifically targeting older patients with advanced cancer. PACE-Mobil-PBL supports the development of health promoting guidelines for older patients with cancer, and the study results will provide new and valuable knowledge in this understudied field.

trial registrationThe study was prospectively registered at ClinicalTrials.gov on January 26, 2018 (ID: NCT03411200 ).

Indexed as

Randomized Controlled Trials as TopicAgedAged, 80 and overBiliary Tract NeoplasmsCombined Modality TherapyDirective CounselingExercise TherapyFemaleHumansLung NeoplasmsMalePalliative CarePancreatic NeoplasmsQuality of LifeTreatment OutcomeAdvanced cancerBiliary tract cancerCancerCounselingExerciseLung cancerMobilizationMultimodal interventionOlderPancreatic cancerPhysical activity

Identifiers

PMID30261853
PMCPMC6161425

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.