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

Nutrients

Aug 2022

DOI: 10.3390/nu14153234

Citations:22

Influential Citations:1

Interventional (Human) Studies

Enhanced Details

Methods

Three-arm randomized controlled trial of adults newly diagnosed with upper GI cancer planning anticancer treatment, recruited from public and private health services in southeast Victoria, Australia (April 2017–July 2019). N=111 randomized to Usual Care (n=37), Telephone-delivered nutrition counselling (n=38), or Mobile App-delivered nutrition counselling (n=36). Baseline: mean ages 63.2, 67.5, and 66.6 years; majority male; tumor sites: oesophageal, gastric, pancreatic; cancer stages ranged from resectable to metastatic. Intervention: 18 weeks of dietitian-led nutrition counselling delivered by telephone (synchronous) or mobile app (asynchronous) in addition to usual care; follow-up at 3, 6, and 12 months. Allocation concealment via opaque envelopes; assessors blinded to allocation; no dosing information collected.

Results

Quality-adjusted life years (QALYs) and overall survival over 12 months did not differ between intervention groups and usual care. Early, intensive nutrition counselling at home did not improve QoL or survival. Telephone-delivered counselling achieved earlier and more frequent nutrition contacts and showed some attenuation of weight loss compared with mobile-app delivery and control; asynchronous mobile-app delivery had higher withdrawals and lower acceptance. Implications: achieving nutritional adequacy in upper GI cancer may require a multidisciplinary approach beyond behavioural counselling alone (potentially including enteral/parenteral nutrition); e-health delivery can enable earlier access but requires improved engagement and patient-centered design.

Limitations

Withdrawals were higher in the mobile-app group and missing data were more common there; generalisability limited to English-speaking adults in a Melbourne-area setting; recruitment was limited to one geographic area; some nutritional outcomes could not be fully captured (SF-PG-SGA in-person exam not feasible); not a fully blinded design for participants; sample size may limit detection of small effects; 12-month follow-up may not capture longer-term outcomes.

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. show less