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Exploring potential benefit of earlier nutritional interventions in adults with upper gastrointestinal cancer: a randomised trial

Pilot study of efficacy of an early and intensive nutrition intervention model, compared to usual care, for improving health-related quality of life amongst patients with oesophageal or stomach cancer

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000005954
Enrollment
50
Registered
2011-01-04
Start date
2011-01-12
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study looks at the efficacy of an early and frequent nutrition intervention model, compared to usual care, for improving the quality of life in people with oesophageal or stomach cancer Who is it for? You can join this study if you have cancer of the oesophagus or stomach and will have surgery and/or chemotherapy at Southern Health in Victoria. Trial details Participants will be i n two groups. One group will receive the usual dietetic consultation at the time of surgery or chemotherapy which involves a completing a malnutrition screening questionnaire and referral to hospital dietician services if appropriate. The other group will receive early (at the time of diagnosis) and frequent dietetic assessment. This will involve an initial telephone or face-to-face interview lasting at least 30 minutes and weekly follow-up telephone calls lasting 15 minutes for 18 weeks and then at week 26. Oral nutritional supplement samples will be given to participants at the discretion of the treating dietician. The aim of the study is to compare the quality of life, nutritional status and patient satisfaction with dietetic intervention in the two groups.

Interventions

Participants randomised to the intervention group will undergo an initial nutritional assessment via telephone within 2 days of receipt of referral from the treating consultant. Participants will receive individualised nutrition care in the form of weekly intensive nutrition assessment and nutrition intervention by the research dietitian via telephone contact interview or face to face interview if attending Monash Medical Centre and written nutritional education information regarding nutrition i

Participants randomised to the intervention group will undergo an initial nutritional assessment via telephone within 2 days of receipt of referral from the treating consultant. Participants will receive individualised nutrition care in the form of weekly intensive nutrition assessment and nutrition intervention by the research dietitian via telephone contact interview or face to face interview if attending Monash Medical Centre and written nutritional education information regarding nutrition impact symptoms and dietary management. Dietitian interviewers will try to ascertain information in the areas of; i) oral intake/food intake, ii) presence/absence of nutrition impact symptoms, iii) physical function, and iv) other relevant dietary information. The initial telephone call will last approximately 30 minutes as a detailed dietetic interview will be conducted. Follow-up telephone calls are anticipated to last approximately 15 minutes. Motivational interviewing techniques will be incorporated into the follow-up telephone calls to promote adherence to the recommended course of action. Oral nutritional supplement samples will be provided as required at the discretion of the treating dietitian. Patients will be consulted weekly for 18 weeks and then at week 26.

Sponsors

Mary Anne Silvers
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion: i) All patients with a histological proven diagnosis of cancer of the oesophagus or stomach who are to undergo surgery and/or chemotherapy at Southern Health ii) Provision of consent

Exclusion criteria

Exclusion: i) Under 18 years of age ii) Patients diagnosed with recurrent disease iii) Patients with physical, cognitive, language or emotional problems would prevent participation as determined by treating consultant iv) Patients who were to undergo surgery and/or chemotherapy at another health service

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026