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Randomized Controlled Trial
. 2022 Aug 7;14(15):3234.
doi: 10.3390/nu14153234.

Effect of Early and Intensive Telephone or Electronic Nutrition Counselling Delivered to People with Upper Gastrointestinal Cancer on Quality of Life: A Three-Arm Randomised Controlled Trial

Catherine E Huggins  1   2 , Lauren Hanna  1   3 , Kate Furness  3   4 , Mary Anne Silvers  3 , June Savva  3 , Helena Frawley  4 , Daniel Croagh  5   6 , Paul Cashin  5   6 , Liang Low  5 , Judy Bauer  7 , Helen Truby  4   7 , Terry P Haines  4   8
Affiliations
Randomized Controlled Trial

Effect of Early and Intensive Telephone or Electronic Nutrition Counselling Delivered to People with Upper Gastrointestinal Cancer on Quality of Life: A Three-Arm Randomised Controlled Trial

Catherine E Huggins et al. Nutrients. .

Abstract

Background: Delay in dietetic service provision for upper gastrointestinal cancer exacerbates disease-related malnutrition and consequently increases morbidity and mortality. Dietetic services are usually referral-based and provided face-to-face in inpatient or outpatient settings, which can delay the commencement of nutrition care. The aim of this study was to provide intensive dietetic intervention close to the time of diagnosis for upper gastrointestinal cancer and assess the effect on quality-adjusted life years.

Methods: A three-arm randomised controlled trial of adults newly diagnosed with upper gastrointestinal cancer was performed. A behavioural-based, individually tailored, symptom-directed nutrition intervention was provided in addition to usual care, delivered by a dietitian using a telephone (synchronously) or a mobile application (asynchronously) for 18 weeks, compared with a usual care control group. Data were collected at baseline, three, six, and twelve months post-randomisation. The primary outcome was quality-adjusted life years (EQ-5D-5L quality of life assessment tool). Data were analysed using linear mixed models.

Results: One hundred and eleven participants were randomised. Quality-adjusted life years were not different in the intervention groups compared with control (telephone: mean (95% CI) 0.04 (0.43, 2.3), p = 0.998; App: -0.08 (-0.18, 0.02), p = 0.135) after adjustment for baseline, nutrition risk status, age, and gender. Survival was similar between groups over 12 months. The asynchronous mobile app group had a greater number of withdrawals compared with the telephone group.

Conclusion: Early and intensive nutrition counselling, delivered at home, during anticancer treatment did not change quality-adjusted life years or survival over 12 months compared with usual care. Behavioural counselling alone was unable to achieve nutritional adequacy. Dietetic services delivered asynchronously using a mobile app had low acceptance for patients undergoing anticancer treatment.

Trial registration: 27 January 2017 Australian and New Zealand Clinical Trial Registry, ACTRN12617000152325.

Keywords: behaviour change; dietetic intervention; mHealth; malnutrition; quality-adjusted life years; upper gastrointestinal cancer.

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Conflict of interest statement

All authors have completed the ICMJE uniform disclosure form. L.H., K.F., M.-A.S., J.S., D.C., P.C. and L.L. were all employees of the Health Service that was the predominant site of recruitment. D.C., P.C. and L.L. referred patients with a histological diagnosis of included cancers, but were not involved with screening, obtaining informed consent, or randomisation. T.H. has provided expert witness testimony on the topic of the prevention of falls in hospitals for Minter Ellison Law Firm and K&L Gates Law Firm within the past 36 months.

Figures

Figure 1
Figure 1
Flowchart of participants over the 12-month follow-up. Multiple imputation was used to replace missing individual data points (other than due to death) for conducting comparisons in mean QALY per participant between groups. Secondary data were analysed without imputation for missing data. Ax, assessment.
Figure 2
Figure 2
Time from randomisation to first contact with a dietitian. The first contact with a dietitian was significantly delayed in the usual care group compared with the intervention groups (telephone mean (SD) 5 (4) days, range 0–16 days n = 38; mobile app 5 (4) days, range 0–14 days, n = 33 noting that three participants withdrew prior to first contact) compared with the control group (70 (104) days, range 1–365 days, n = 30; n = 7 reported no data about contact with a dietitian). Data were censored at the end of the follow up period of 365 days.
Figure 3
Figure 3
Change in health status of participants from baseline to 12-month follow-up. EQ-5D-5L utility score (A) and visual analogue scale of perceived health on day of assessment (B). Data are presented as mean (SD).
See this image and copyright information in PMC

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