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, Dorte Lisbet Nielsen, Mary Jarden, 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, Dorte Lisbet Nielsen, Mary Jarden

Abstract

Background: Several 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.

Methods: PACE-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 registration: The study was prospectively registered at ClinicalTrials.gov on January 26, 2018 (ID: NCT03411200 ).

Keywords: Advanced cancer; Biliary tract cancer; Cancer; Counseling; Exercise; Lung cancer; Mobilization; Multimodal intervention; Older; Pancreatic cancer; Physical activity.

Conflict of interest statement

Authors’ information

MKM is a PhD student from the University of Copenhagen, with an educational background as a RN and MHSc. JSJ, IC, LEN, FOL and DLN are oncologists, CML is a geriatrician, AV is a research physiotherapist, AMR is a physiotherapist, AT is a statistician, BZ is a medical physiologist, and MJ is a senior nursing researcher.

Ethics approval and consent to participate

The study protocol, version 2.0 from February 1st 2018, is approved by the Regional Ethics Committee for the Capital Region of Denmark (j.nr: H-18001096). Any changes in the protocol will be reported to the Regional Ethics Committee. Informed verbal and written content will be obtained for all participants before inclusion in the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
PACE-Mobil-PBL study design. Abbreviations: BTC (biliary tract cancer), LC (lung cancer), PC (pancreatic cancer)

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