Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05544318 |
| Other study ID # |
267889 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2022 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
February 2023 |
| Source |
University of Oslo |
| Contact |
Christine Henriksen, PhD |
| Phone |
99003128 |
| Email |
christine.henriksen[@]medisin.uio.no |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this study, we aim to reduce the burden of malnutrition in cancer patients by implementing
and evaluating an improved nutritional support, using digital communication and registration
tools during the clinical pathway. The project targets a group of patients with a high
frequency of malnutrition, due to cancer and the subsequent therapy, where knowledge on the
efficient and cost-effective treatment is scarce. The effect of the improved nutrition
support will be evaluated in a randomised controlled trial, and the primary endpoint is the
prevalence of malnutrition. The long-term goal is to benefit the patients by increasing the
completion rate of cancer treatment, reducing the infection rate, need for antibiotics, the
total length of hospital stays and number of non-elective re-admissions, and thus increasing
the patients' quality of life and survival. The project will be patient-orientated and result
in a sustainable approach for the management of malnutrition.
Description:
WP1. Effect of the improved nutritional support
Task 1.1 Recruitment of participants
Consenting, eligible participants will be screened for malnutrition using NRS-2002 by the PhD
student, and randomised to intervention or control group stratified for malnutrition risk.
All participants will go through a baseline assessment at the Center for clinical nutrition.
Participants in the intervention group will be scheduled for a first dietitian visit at the
nutrition outpatient clinic at OUH, at the same day as the baseline assessment.
Task 1.2 Intervention
Included in the green approach to improved nutritional support are:
- Individual dietitian support for patients at risk
- Self-monitoring of food intake and weight
Digital communication tools to enable frequent follow-up during the cancer treatment.
Patients at risk of malnutrition will be given individual goals on energy- and protein
intake, weight and body composition. The goals will be converted to specific, measurable and
acceptable guidance according to the motivational interview techniques.
Participants will be provided with a tablet computer to monitor dietary intake using the
FoodCapture system, intended for nutrition monitoring and follow-up. The interface of
FoodCapture consists of an app for mobile devices and a website and includes functions to
record, evaluate and document nutrition and generate reports for health professionals.
The technical development of the FoodCapture device is performed by the University Centre for
Information Technology (USIT) at the University of Oslo. A web form is used for data flow in
the app and data are sent to 'Services for sensitive data' (Tjenester for sensitive data,
TSD), both hosted by USIT. Information registered in the FoodCapture app and the recordings
of dietary intake are sent encrypted through the web form to TSD. The TSD system is a
high-security private cloud eInfrastructure to process and store sensitive research data. It
is included in NorStore, the Norwegian national infrastructure for handling and storing
scientific data (21).
All data recorded in the FoodCapture app are continuously sent to TSD. In cases of technical
problems or loss of internet connection, the data are stored temporarily in an encrypted
format before being sent to TSD when the device resumes an internet connection.
To gain access to the FoodCapture web report, healthcare professionals have to complete an
access form, that has to be approved by an administrator. Log-in to the webserver is done
through the common log-in solution to public services in Norway: ID-porten and authentication
is sent to the TSD server to verify access to the web report. The FoodCapture tool is CE
marked as a medical device class 1 and registered at the Norwegian Medicines Agency.
Self-monitoring of weight will be facilitated by a digital scale, with a wireless connection
to the tablet computer. All data from the digital scale will be transferred to "Services for
Sensitive Data" (TSD) and then becomes available for the dietitian, who contacts patients in
need of support.
The intervention includes physical and digital follow-up sessions (telephone or
video-meetings) with the patient's personal dietician, who will be the main responsible for
the nutritional support throughout the clinical pathway. The patient follow-up frequency will
be customised, depending on the situation and the patient's needs, but will at a minimum
include one physical visits in addition to digital follow-ups during the first 6 months.
Follow-up visits. All participants will be followed up after 6 months to assess malnutrition
status. The 12 months follow-up visit is included to evaluate the long-term effect on quality
of life and survival.
Sample size: Based on our previous experience with the effect of FoodCapture, we expect a
difference in the prevalence of malnutrition of 17 percentage points after 6 months. With a
statistical power of 80 % and a significance level of 5 %, we will need a total of 104
patients: 52 in each group to detect expected difference. To allow for a 20 % drop-out, we
will recruit 130 participants, and anticipate that the recruitment will last for about 7
months.
WP2. Implementation of improved nutritional support
WP2 will be conducted in close cooperation with the users, including patients, health care
professionals and next-of-kin. An implementation study will be performed before and in
parallel with the effect study (WP1), using a mixed-method approach with qualitative and
quantitative measurements. This WP consists of three tasks:
Task 2.1 First, we will explore the readiness and potential barriers and facilitators of the
improved nutritional support by using the Consolidated Framework for Implementation Research.
Data will be gathered in focus group discussions.
Task 2.2 The identified barriers and facilitators will be used to create a plan for the
implementation of the improved nutritional support. The plan will include implementation
strategies, like methods for stakeholder engagement, management support, training and
follow-up.
Task 2.3 Finally, we will study the implementation outcomes as described by Proctor et al
(30) and explore how the nutritional support is perceived among patients and their
next-of-kins. This will include acceptability and practical use of the nutritional support
and compatibility with the clinical pathway, if the intervention was delivered as intended,
and how the intervention can reach sustainability in the future. Data will be gathered using
online questionnaires, technical log-data, focus group discussions and individual interviews
WP3. Economic evaluation on nutritional support
WP3 will be conducted in close cooperation with experts on health economics at the Clinical
Trial Unit at OUH. Economic evaluation is defined as the comparison of alternative options in
terms of cost and consequences (outcomes).
To calculate the economic impact of the improved nutritional support, based on the results of
WP1. We will perform a cost-utility analysis of the nutritional support compared to standard
routine care in cancer patients, taking a societal perspective. The generic outcome is
Quality adjusted life-years (QALYs) measured by the generic instrument EQ-5D-5L. In order to
generate QALYs, health utilities are needed. Utilities are preference weights, measured on a
scale from 0 (dead) and 1 (full health). Data will be collected through self-reported
measures and electronic patient records, and the health economic analysis will include
following costs:
Intervention related costs, mainly related to intervention implementation (introduction to
health care personnel and patients, maintenance (software and security updates) and personnel
costs due to follow-up.
Health care costs/direct costs, mainly related to use of health care services (including
primary care; general practitioner, physical therapy, psychology visits, secondary care;
hospitalization, readmission, outpatient visits, use of antibiotics, enteral and parenteral
nutrition products.
Societal costs/indirect costs, including work absence (i.e., productivity loss).
