None listed
Conditions
Brief summary
The aim of this study is to examine whether very early dietetic intervention for people with newly diagnosed upper gastrointestinal cancer will enhance quality adjusted life years lived compared with usual dietetic care. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have primary new diagnosis of oesophageal or stomach or pancreatic cancer. Study details Participants will be randomised (allocated by chance) to one of three treatment groups (usual care, early intervention telephone or early intervention electronic messages via mobile application). For those randomised to intervention groups, participants will receive the active intervention for 18 weeks, commencing as soon as possible after diagnosis. Personalised nutrition support/ advice will be provided. Outcomes will be measured at baseline and at follow up at 3, 6 and 12 months. It is hoped that this study will demonstrate effectiveness of early and frequent dietetic intervention in enhancing quality of life and that intervention will be cost-effective while also minimising nutritional decline (weight loss).
Interventions
BRIEF NAME THAT DESCRIBES THE INTERVENTION INTERVENTION GROUP 1 - Early and frequent nutrition support via telephone WHY To deliver appropriate nutritional support and advice as soon as practicable following diagnosis. WHAT Participants randomised to the telephone intervention group will need regular access to a telephone. Nutrition advice and support will be provided over the phone and tailored to each participant that is, in part, informed by the treatment pathway planned by the multidisciplinary team treating the participant, and also by the needs of the participant throughout the study period. Nutrition information fact sheets will be available to participants which describe strategies for managing nutrition impact symptoms associated with disease progression and treatment side effects (e.g managing fatigue, nausea, vomiting). Information/resources will be posted via mail or email to the participant. Participants will also be provided with forms to order oral nutrition supplements if deemed relevant. All participants will continue to receive usual nutrition care provided by their health service. For those randomised to an intervention group, participants will receive the active intervention for 18 weeks, commencing as soon as possible after diagnosis. PROVIDED BY The intervention will be provided by a research dietitian who has experience working with the upper gastrointestinal cancer population and is skilled in using behaviour change techniques. HOW The early and frequent nutrition support/ advice will be delivered to individual participants by telephone. WHERE The intervention delivery occurs wherever the participant chooses to be provided they have access to a telephone including their home, holiday destination, at hospital, etc.. WHEN and HOW MUCH * Initial contact within first week from date of recruitment. * First follow-up within first week after initial contact. * Fortnightly contact (15 -30 minutes) thereafter for general check-ups or more frequent at discretion of treating dietitian over a period of 18 weeks. * Email contact can replace phone call for fortnightly follow-up if the next scheduled session is not a pre-specified goal review. TAILORING Individual nutrition support/ advice will be provided. Participants’ needs will vary depending on the tumour location, the treatment pathway, nutrition impact symptoms and treatment side effects experienced. Participants will set weekly goals aimed at promoting nutritional intake. HOW WELL Adherence and fidelity will be assessed by 1) recording the number and duration of telephone calls between the research dietitian and participant during the 18 week intervention period; 2) a record of the behaviour change techniques used by the research dietitian (according to Behaviour Change Technique Taxonomy (v1) (Michie et al, Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6). INTERVENTION GROUP 2 - Early and frequent nutrition support via mobile application WHY The purpose of the mobile application intervention group is to deliver appropriate nutritional support and advice as soon as practicable following diagnosis. WHAT Participants randomised to the intervention group will be provided with an iPad and mobile sim card that has an internet-enabled application downloaded (myPace) to facilitate communication between the research dietitian and the participants in this group. Participants may choose to use their own iPad or smartphone and download the myPace application. Nutrition advice and support will be tailored to each participant that is, in part, informed by the treatment pathway planned by the multidisciplinary team treating the participant, and also by the needs of the participant throughout the study period. Nutrition information fact sheets will be available to participants which describe strategies for managing nutrition impact symptoms associated with disease progression and treatment side effects (e.g managing fatigue, nausea, vomiting). The mobile application can be used for email and text message communication, and can save and store these messages along with resources provided to the participant. Participants will also be provided with forms to order oral nutrition supplements if deemed relevant. All participants will continue to receive usual nutrition care provided by their health service. For those randomised to an intervention group, participants will receive the active intervention for 18 weeks, commencing as soon as possible after diagnosis. The participants in the mobile application group will be able to access the application up to week 26, however tailored nutrition support will not be available beyond 18 weeks. PROVIDED BY The intervention will be provided by a research dietitian who has experience working with the upper gastrointestinal cancer population and is skilled in using behaviour change techniques. HOW The early and frequent nutrition support/ advice will be delivered to individual participants by mobile application (myPace). WHERE The intervention delivery occurs wherever the participant chooses to be provided they have access to an internet connection, including their home, holiday destination, at hospital etc. WHEN and HOW MUCH * Initial contact within first week from date of recruitment. * First follow-up within first week after initial contact. * Fortnightly contact (15 -30 minutes) thereafter for general check-ups or more frequent at discretion of treating dietitian over a period of 18 weeks. TAILORING Individual nutrition support/ advice will be provided. Participants’ needs will vary depending on the tumour location, the treatment pathway, nutrition impact symptoms and treatment side effects experienced. Participants will set weekly goals aimed at promoting nutritional intake. HOW WELL Adherence and fidelity will be assessed by 1) recording the number of electronic messages exhanged between the research dietitian and participant and the time lapse between responses (i.e participant to reply to research dietitan; and research dietitan to reply to participant) during the 18 week intervention period; 2) a record of the behaviour change techniques used by the research dietitian (according to Behaviour Change Technique Taxonomy (v1) (Michie et al, Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6).
Sponsors
Study design
Eligibility
Inclusion criteria
1. Primary new diagnosis of oesophageal or stomach or pancreatic cancer 2. Not receiving end of life care
Exclusion criteria
1. Insufficient knowledge of English language to be able to consent 2 Unable to provide informed consent