Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2018 Nov 29;18(1):1181.
doi: 10.1186/s12885-018-5089-8.

A process and mechanism of action evaluation of the effect of early and intensive nutrition care, delivered via telephone or mobile application, on quality of life in people with upper gastrointestinal cancer: a study protocol

Kate Furness  1   2   3 , Catherine E Huggins  4 , Lauren Hanna  5   4 , Mary Anne Silvers  5 , Paul Cashin  6   7 , Liang Low  6   7 , Daniel Croagh  6   7 , Terry P Haines  8   9
Affiliations
Randomized Controlled Trial

A process and mechanism of action evaluation of the effect of early and intensive nutrition care, delivered via telephone or mobile application, on quality of life in people with upper gastrointestinal cancer: a study protocol

Kate Furness et al. BMC Cancer. .

Abstract

Background: Cancers of the upper gastrointestinal tract commonly result in malnutrition, which increases morbidity and mortality. Current nutrition best practice lacks a mechanism to provide early and intensive nutrition support to these patients. A 3-arm parallel randomised controlled trial is testing the provision of a tailored, nutritional counselling intervention delivered using a synchronous, telephone-based approach or an asynchronous, mobile application-based approach to address this problem. This protocol outlines the design and methods that will be used to undertake an evaluation of the implementation process, which is imperative for successful replication and dissemination.

Methods: A concurrent triangulation mixed methods comparative analysis will be undertaken. The nutrition intervention will be provided using best practice behaviour change techniques and communicated either via telephone or via mHealth. The implementation outcomes that will be measured are: fidelity to the nutrition intervention protocol and to the delivery approach; engagement; acceptability and contextual factors. Qualitative data from recorded telephone consultations and written messages will be analysed through a coding matrix against the behaviour change techniques outlined in the standard operating procedure, and also thematically to determine barriers and enablers. Negative binomial regression will be used to test for predictive relationships between intervention components with health-related quality of life and nutrition outcomes. Post-intervention interviews with participants and health professionals will be thematically analysed to determine the acceptability of delivery approaches. NVivo 11 Pro software will be used to code for thematic analysis. STATA version 15 will be used to perform quantitative analysis.

Discussion: The findings of this process evaluation will provide evidence of the core active ingredients that enable the implementation of best practice nutrition intervention for people with upper gastrointestinal cancer. Elucidation of the causal pathways of successful implementation and the important relationship to contextual delivery are anticipated. With this information, a strategy for sustained implementation across broader settings will be developed which impact the quality of life and nutritional status of individuals with upper gastrointestinal cancer.

Trial registration: 27th January 2017 Australian and New Zealand Clinical Trial Registry ( ACTRN12617000152325 ).

Keywords: Behaviour change; Dietetic intervention; Effectiveness; Engagement; Oesophagogastric; Pancreatic cancer; Process evaluation; mHealth.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

This study has undergone full ethical review by the Monash Health Human Research Ethics Committee and was approved 14th October 2016 (HREC/16/MonH/290). Site-specific authorisation has been granted for all sites (Monash Health, Cabrini Health and Peninsula Health). Participants will provide informed verbal consent to participate in the study, which is the approved consent process by the main ethics committee (Monash Health Human Research Ethics) and the other sites (Cabrini health and Peninsula Health). The decision to use verbal consent rather than written consent was based on feedback from consumer representatives who sit on the study advisory committee. Written informed consent will be sought to access participant data from the Medicare and Pharmaceutical Benefits Scheme databases. Health professionals will provide written consent.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Conceptual framework. Framework of the delivery of nutrition intervention for participants who are randomised to the intervention. Dietitian completes an initial nutrition assessment over the phone. The dietitian identifies and prioritises issues to be addressed e.g. psycho-social, nutrition impact symptoms, nutrition optimisation and/or pharmacological support. Goals are set, then supporting behaviour change techniques are employed taken from the Behaviour Change Technique Taxonomy V1 (BCTTV1) [37]. At each weekly/fortnightly nutrition consultation goals are reviewed and strategies negotiated to promote achievement of goals. The effectiveness of the intervention will be assessed through the outcome measures of health-related quality of life (HRQoL). nutritional status and survival
Fig. 2
Fig. 2
Process evaluation and mechanisms of action flow chart. This flow chart presents the key functions involved in the process and mechanisms of action evaluation of this randomised controlled trial. The green boxes form the most integral components of this evaluation. Analysis using a mixed methods approach allows for the interpretation of outcomes. Adapted from Moore et al [40]
Fig. 3
Fig. 3
MyPace [55]
Fig. 4
Fig. 4
MyPace Small Steps [55]
Fig. 5
Fig. 5
My Pace Progress Summary and Weight Graph [55]
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Andreyev HJ, Norman AR, Oates J, Cunningham D. Why do patients with weight loss have a worse outcome when undergoing chemotherapy for gastrointestinal malignancies? Eur J Cancer. 1998;34(4):503–509. doi: 10.1016/S0959-8049(97)10090-9. - DOI - PubMed
    1. Bower MR, Martin RC., 2nd Nutritional management during neoadjuvant therapy for esophageal cancer. J Surg Oncol. 2009;100(1):82–87. doi: 10.1002/jso.21289. - DOI - PubMed
    1. D BJ, Susan A, L DW, M HJ, Teresa B, A IE, Marina R. Evidence based practice guidelines for the nutritional management of cancer cachexia. Nutr Diet. 2006;63(s2):S3–S32. doi: 10.1111/j.1747-0080.2006.00099.x. - DOI
    1. Farreras N, Artigas V, Cardona D, Rius X, Trias M, Gonzalez JA. Effect of early postoperative enteral immunonutrition on wound healing in patients undergoing surgery for gastric cancer. Clin Nutr. 2005;24(1):55–65. doi: 10.1016/j.clnu.2004.07.002. - DOI - PubMed
    1. Gavazzi C, Colatruglio S, Sironi A, Mazzaferro V, Miceli R. Importance of early nutritional screening in patients with gastric cancer. Br J Nutr. 2011;106(12):1773–1778. doi: 10.1017/S0007114511002509. - DOI - PubMed

Publication types

LinkOut - more resources