Colo-rectal Cancer Clinical Trial
Official title:
Can People Living With and Beyond Colorectal Cancer Make Lifestyle Changes With the Support of Health Technology
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | June 14, 2019 |
Est. primary completion date | May 3, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. All adult outpatients, over the age of 18, under The Royal Marsden NHS Foundation Trust with a formal diagnosis of stage I-III CRC. 2. Participants must have completed treatment for CRC (defined as 3 weeks after stopping chemotherapy) and own a smart phone. Exclusion Criteria: 1. Patients who have metastatic disease 2. 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. 3. Patients with a BMI >35 kg/m2 4. People with a prior formal diagnosis of memory impairment 5. Patients who cannot read or write English |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Royal Marsden NHS Foundation Trust |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | To examine the demographics of people with CRC who are willing to participate in a study focused on lifestyle changes | The demographics including but not limited to age and gender of patients | Week 1 after patient recruitment | |
Secondary | To ascertain the proportion of CRC patients willing to interact with the intervention | Proportion of patients willing to take part in this study. This will be defined as those accepting to register to the study by completing the baseline three day food diary out of those approached to take part. | Week 5 after patient recruitment | |
Secondary | To identify participant reported barriers and acceptability of the use of remote reviews using telephones and digital technology | Specific barriers preventing the remote follow ups using telecommunications and digital technology for diet and lifestyle changes will be identified and their frequency and percentages will be reported. These will be recorded on an end of intervention evaluation form and the analysis will be mainly qualitative. | study completion | |
Secondary | To explore the frequency of telephone contact by participants during the 2 month intervention | The number and duration of telephone calls between dietitian and participant will also be summarized. | Week 10 after patient recruitment | |
Secondary | To explore how much time is required for a healthcare professional to deliver the healthy diet and lifestyle intervention | Measure how much time is required to deliver the intervention by dietitians. The dietitian will log on a spread sheet time spent arranging appointments and interacting with participants in person and the telephone | Study completion | |
Secondary | To ascertain whether there was any change in diet and lifestyle factors from baseline to end of intervention (2 months) | The proportion of participants that had a change in their diet (defined as increased fibre and fruit and vegetables, decreased red meat, processed meat and alcohol) as assessed by comparing parameters from the baseline and end of intervention (at 2 months) three day food diary | Study completion |
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