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.

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.

Effect of early and intensive nutrition care, delivered via telephone or mobile application, on quality of life in people with upper gastrointestinal cancer: study protocol of a randomised controlled trial.

BACKGROUND: A major challenge for those living with cancers of the upper gastrointestinal tract (oesophagus, stomach and pancreas), is the impact of the disease and treatment on nutritional status and quality of life. People with cancer and malnutrition have a greater risk of morbidity and mortality. Nutrition intervention is recommended to commence immediately in those who are malnourished or at risk of malnutrition. Novel cost-effective approaches that can deliver early, pre-hospital nutrition intervention before usual hospital dietetic service is commenced are needed. Linking clinicians and patients via mobile health (mHealth) and wireless technologies is a contemporary solution not yet tested for delivery of nutrition therapy to people with cancer. The aim of this study is to commence nutrition intervention earlier than usual care and evaluate the effects of using the telephone or mHealth for intervention delivery. It is hypothesised that participants allocated to receive the early and intensive pre-hospital dietetic service will have more quality-adjusted life years lived compared with control participants. This study will also demonstrate the feasibility and effectiveness of mHealth for the nutrition management of patients at home undergoing cancer treatment. METHODS: This study is a prospective three-group randomised controlled trial, with a concurrent economic evaluation. The 18 week intervention is provided in addition to usual care and is delivered by two different modes, via telephone (group 1) or via mHealth (group 2), The control group receives usual care alone (group 3). The intervention is an individually tailored, symptom-directed nutritional behavioural management program led by a dietitian. Participants will have at least fortnightly reviews. The primary outcome is quality adjusted life years lived and secondary outcomes include markers of nutritional status. Outcomes will be measured at three, six and 12 months follow up. DISCUSSION: The findings will provide evidence of a strategy to implement early and intensive nutrition intervention outside the hospital setting that can favourably impact on quality of life and nutritional status. This patient-centred approach is relevant to current health service provision and challenges the current reactive delivery model of care. TRIAL REGISTRATION: 27th January 2017 Australian and New Zealand Clinical Trial Registry ( ACTRN12617000152325 ).

Long-term follow-up of the potential benefits of early nutritional intervention in adults with upper gastrointestinal cancer: a pilot randomised trial.

PURPOSE: This study aimed to evaluate the long-term survival of all patients who participated in a pilot randomised trial of an early nutritional intervention for adults with upper gastrointestinal cancer. It also sought to identify factors that predicted patient mortality. METHODS: All participants (n = 21) who were randomised into the original study were followed for a maximum of 5 years and 2 months (final follow-up April 2016). The primary outcome measure was time from date of recruitment until date of death, ascertained by the Victorian Cancer Registry and/or Monash Health Scanned Medical Records. Secondary analyses were conducted to identify factors that adversely affected survival. RESULTS: At the end of the follow-up period, three patients were alive in the nutrition intervention group whilst only two patients were living from the standard care group. Visual evaluation of the Kaplan-Meier survival curves demonstrated a possible survival benefit from being exposed to the intervention between 6 months and 1.4 years post-recruitment, though this benefit dissipated soon after. The intervention was not associated with increased survival in univariate analyses, but was after adjustment for other factors found to adversely impact on survival (adjusted hazard ratio 0.12 (95% CI 0.02-0.72) p = 0.02). These factors were being a smoker (14.2 (1.43 to 140.67), p = 0.02); low baseline physical functioning (1.11 (1.01 to 1.21), p = 0.03); high baseline fatigue (1.09 (1.02-1.16), p = 0.007); and high baseline dyspnoea (1.08 (1.02-1.13), p = 0.003). CONCLUSION: Early and intensive nutrition intervention may increase the survival of people with upper gastrointestinal cancer.

Potential benefits of early nutritional intervention in adults with upper gastrointestinal cancer: a pilot randomised trial.

PURPOSE: This study aimed to test whether a very early nutrition intervention delivered over the telephone was feasible and could improve outcomes amongst patients with upper gastrointestinal cancer. METHODS: Participants with a histologically proven new diagnosis of primary oesophageal or stomach cancer and who were to undergo surgery and/or chemotherapy were randomised to receive either standard nutrition care (SC) or early and intensive nutrition intervention (NI) over the telephone/face-to-face. Participants were followed for 6 months. The primary outcome was quality of life (QoL), assessed using the European Organization for Research and Treatment of Cancer Global Quality of Life questionnaire C30 (EORTC QLQ-C30) and the European Quality of Life Instrument (EQ-5D) tool; secondary outcomes were nutritional status and survival. RESULTS: Twenty-one participants were recruited (11 SC and 10 NI). At baseline, the prevalence of malnutrition was 90 %. Compared with SC, the NI group had a significantly higher EORTC global QoL score at the first mid-study follow-up (coefficient (95 % CI) 21.0 (12.1, 29.9) adjusted for baseline, p < 0.001) and at 26 weeks (28.4 (21.3, 35.4) adjusted for baseline, p < 0.001). Nutritional risk score was lower (p < 0.001), and loss of body weight attenuated (p < 0.001) in the NI group compared with SC. Six deaths occurred during the study, five in the SC group and one in the NI group (p = 0.06). The mean time spent with a dietitian per contact was significantly less for the NI group compared with SC (16(3) vs 40(6) min per dietetic contact, p < 0.001). CONCLUSIONS: This pilot study has shown the potential of a novel telephone-based early and intensive dietetic model of care for newly diagnosed upper gastrointestinal cancer patients.