Lessons learned from a randomized controlled trial on a home delivered meal service in advanced cancer patients undergoing chemotherapy: a pilot study

BMC Nutrition

Vera IJmker-Hemink¹  Manon van den Berg¹  Geert Wanten²  Sandra Beijer³  Nora Lize³  Natasja Raijmakers⁴ 

[1] Department of Gastroenterology and Hepatology - Dietetics and Intestinal Failure, Radboudumc, Nijmegen, The Netherlands;Department of Gastroenterology and Hepatology, Radboudumc, Nijmegen, The Netherlands;Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands;Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands;Netherlands Association for Palliative Care (PZNL), Utrecht, the Netherlands;

关键词: Pilot study;    Cancer;    Nutritional intervention;    Chemotherapy;    Qualitative interviews;   

DOI  :  10.1186/s40795-021-00407-5

来源: Springer

【 摘 要 】

BackgroundPerforming a randomized controlled trial (RCT) in the field of nutrition is challenging and success highly depends on understanding the factors that influence recruitment and dropout of participants. Our aim was to assess the feasibility of a RCT that evaluated a home delivered meal service in advanced cancer patients while receiving chemotherapy.MethodsThis pilot RCT aimed to enroll 20 participants who were randomized into the home delivered meal service group or usual care group. Study procedures took place before chemotherapy (T0), 3 weeks after T0 (T1), 6 weeks after T0 (T2) and 3 months after T2 (T3). All information regarding recruitment, dropout and study procedures was recorded. Patient satisfaction was assessed by in-depth interviews.ResultsOver 7 months, 20 of 41 approached patients (49%) were included, followed by a dropout rate of 35%. At baseline, hand grip strength (n = 8/16), the Short Physical Performance Battery (n = 12/16) and nutritional intake (n = 8/16) had the highest rate of missing values. Study procedures were not experienced as burdensome and planning of these procedures in line with fixed hospital appointments contributed to this low burden. Keeping the symptom diary was mentioned as being burdensome.ConclusionsIt is feasible to conduct a RCT on a home delivered meal service in advanced cancer patients during chemotherapy, although recruitment is challenging. Close contact of patients with recruiting personnel is essential to sustain motivation. To increase compliance with the study protocol it is important to carefully instruct participants on how to complete questionnaires and to emphasize to use these in the communication with their practitioners.Trial registrationClinicalTrials.gov NCT03382171.

【 授权许可】

CC BY