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. 2021 Feb 16;7(1):4.
doi: 10.1186/s40795-021-00407-5.

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

Vera IJmker-Hemink  1 , Nora Lize  2 , Sandra Beijer  2 , Natasja Raijmakers  2   3 , Geert Wanten  4 , Manon van den Berg  5
Affiliations

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

Vera IJmker-Hemink et al. BMC Nutr. .

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov NCT03382171 .

Keywords: Cancer; Chemotherapy; Nutritional intervention; Pilot study; Qualitative interviews.

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Conflict of interest statement

Mrs. Vera IJmker-Hemink reports grants from Nationaal Fonds Tegen Kanker and from CZ fonds, during the conduct of the study. We would like to thank CZ fonds and Nationaal Fonds tegen Kanker for funding our research.

Figures

Fig. 1
Fig. 1
Study design of the pilot study
Fig. 2
Fig. 2
Flowchart of 7 months recruitment in the pilot study
Fig. 3
Fig. 3
Number of total participants included per week of recruitment and number of included participants after expansion of the in- and exclusion criteria
See this image and copyright information in PMC

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