TY - JOUR

T1 - Engaging the older cancer patient

T2 - Patient Activation through Counseling, Exercise and Mobilization - Pancreatic, Biliary tract and Lung cancer (PACE-Mobil-PBL) - study protocol of a randomized controlled trial

AU - Mikkelsen, Marta Kramer

AU - Lund, Cecilia Margareta

AU - Vinther, Anders

AU - Tolver, Anders

AU - Ragle, Anne Mette

AU - Johansen, Julia Sidenius

AU - Chen, Inna

AU - Engell-Noerregaard, Lotte

AU - Larsen, Finn Ole

AU - Zerahn, Bo

AU - Nielsen, Dorte Lisbet

AU - Jarden, Mary

PY - 2018

Y1 - 2018

N2 - 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 ).

AB - 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 ).

KW - Advanced cancer

KW - Biliary tract cancer

KW - Cancer

KW - Counseling

KW - Exercise

KW - Lung cancer

KW - Mobilization

KW - Multimodal intervention

KW - Older

KW - Pancreatic cancer

KW - Physical activity

UR - http://www.scopus.com/inward/record.url?scp=85054059239&partnerID=8YFLogxK

U2 - 10.1186/s12885-018-4835-2

DO - 10.1186/s12885-018-4835-2

M3 - Journal article

C2 - 30261853

AN - SCOPUS:85054059239

VL - 18

SP - 1

EP - 11

JO - B M C Cancer

JF - B M C Cancer

SN - 1471-2407

M1 - 934

ER -