IJmker-Hemink Vera, Lize Nora, Beijer Sandra, Raijmakers Natasja, Wanten Geert, van den Berg Manon
Department of Gastroenterology and Hepatology - Dietetics and Intestinal Failure, Radboudumc, Nijmegen, The Netherlands.
Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands.
BMC Nutr. 2021 Feb 16;7(1):4. doi: 10.1186/s40795-021-00407-5.
Performing 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.
This 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.
Over 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.
It 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.
ClinicalTrials.gov NCT03382171 .
在营养领域开展随机对照试验（RCT）具有挑战性，其成功在很大程度上取决于对影响参与者招募和退出因素的理解。我们的目的是评估一项RCT的可行性，该试验在晚期癌症患者接受化疗期间评估一项上门送餐服务。
这项试点RCT旨在招募20名参与者，他们被随机分为上门送餐服务组或常规护理组。研究程序在化疗前（T0）、T0后3周（T1）、T0后6周（T2）和T2后3个月（T3）进行。记录所有关于招募、退出和研究程序的信息。通过深入访谈评估患者满意度。
在7个多月的时间里，41名被邀请患者中有20名（49%）被纳入研究，随后退出率为35%。在基线时，握力（n = 8/16）、简短体能测试电池（n = 12/16）和营养摄入量（n = 8/16）的缺失值率最高。研究程序并未给患者带来沉重负担，按照固定的医院预约安排这些程序有助于减轻负担。记录症状日记被认为是一项负担。
在晚期癌症患者化疗期间对上门送餐服务进行RCT是可行的，尽管招募工作具有挑战性。患者与招募人员保持密切联系对于维持其积极性至关重要。为了提高对研究方案的依从性，重要的是要仔细指导参与者如何完成问卷，并强调在与医生沟通时使用这些问卷。
ClinicalTrials.gov NCT03382171 。
