Lifestyle Changes Using Digital Technology in Colorectal Cancer
Can People Living With and Beyond Colorectal Cancer Make Lifestyle Changes With the Support of Health Technology
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
The objective of this small study is to assess the feasibility of remotely delivering a diet and lifestyle intervention following treatment of CRC through telecommunications and digital technology. A DBCI will be implemented among a population of people living with and beyond CRC to help identify if patients find this an easy and achievable way to communicate with a Registered Dietitian. The information gained from this small scale feasibility will be used to help develop a larger study on supporting people with CRC to make a lifestyle change.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2019
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2019
CompletedFirst Posted
Study publicly available on registry
February 21, 2019
CompletedStudy Start
First participant enrolled
March 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2019
CompletedFebruary 21, 2019
February 1, 2019
2 months
February 18, 2019
February 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate whether patients who have undergone CRC treatment are able to comply with remote follow-ups using telephone reviews and digital technology to help promote and track individual healthy lifestyle, diet and PA changes.
Mean percentage of CRC patients who have been able to engage with remote reviews through telecommunications and digital technology at the end of the 2 month intervention. This will be defined as patients that either have completed an online food diary or engaged with the dietitian over the telephone to set and monitor their diet and lifestyle changes.
Week 2 after patient recruitment
Secondary Outcomes (6)
To examine the demographics of people with CRC who are willing to participate in a study focused on lifestyle changes
Week 1 after patient recruitment
To ascertain the proportion of CRC patients willing to interact with the intervention
Week 5 after patient recruitment
To identify participant reported barriers and acceptability of the use of remote reviews using telephones and digital technology
study completion
To explore the frequency of telephone contact by participants during the 2 month intervention
Week 10 after patient recruitment
To explore how much time is required for a healthcare professional to deliver the healthy diet and lifestyle intervention
Study completion
- +1 more secondary outcomes
Study Arms (1)
Lifestyle Arm
OTHERCan people living with and beyond colorectal cancer make lifestyle changes with the support of health technology
Interventions
Written instructions will be provided to participants, to include how to download supportive apps on smartphones. Participants will be asked to complete a 3 day food diary using an online platform (MyFood24) prior to attending a face to face consultation which will reinforce the participant's responsibilities. Participants will be assisted to set specific diet and lifestyle goals. 3 fortnightly follow ups will be arranged via 15 minute telephone consultations, three 24 hour dietary diaries will be completed via MyFood24 prior to each fortnightly digital consultation. Participants will be asked to measure their daily activity via a pedometer on their smart phones. Participants will be asked to complete the Godin leisure time questionnaire to assess changes in leisure time exercise.
Eligibility Criteria
You may qualify if:
- All adult outpatients, over the age of 18, under The Royal Marsden NHS Foundation Trust with a formal diagnosis of stage I-III CRC.
- Participants must have completed treatment for CRC (defined as 3 weeks after stopping chemotherapy) and own a smart phone.
You may not qualify if:
- Patients who have metastatic disease
- Patients who have experienced a significant weight loss \>10% body weight in past 3 months as they are at risk of malnutrition and will be referred to the dietitians for advice beyond healthy living and diet advice.
- Patients with a BMI \>35 kg/m2
- People with a prior formal diagnosis of memory impairment
- Patients who cannot read or write English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Nelson V, Cross AJ, Powell J, Shaw C. Can people living with and beyond colorectal cancer make lifestyle changes with the support of health technology: A feasibility study. J Hum Nutr Diet. 2023 Apr;36(2):554-565. doi: 10.1111/jhn.13008. Epub 2022 Apr 9.
PMID: 35320595DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clare Shaw, BSc, PhD
Royal Marsden NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2019
First Posted
February 21, 2019
Study Start
March 18, 2019
Primary Completion
May 3, 2019
Study Completion
June 14, 2019
Last Updated
February 21, 2019
Record last verified: 2019-02