Lifestyle Changes Using Digital Technology in Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT03849352|
Recruitment Status : Not yet recruiting
First Posted : February 21, 2019
Last Update Posted : February 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Life Style Colo-rectal Cancer||Behavioral: Lifestyle changes with the support of health technology||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Can People Living With and Beyond Colorectal Cancer Make Lifestyle Changes With the Support of Health Technology|
|Estimated Study Start Date :||March 18, 2019|
|Estimated Primary Completion Date :||May 3, 2019|
|Estimated Study Completion Date :||June 14, 2019|
Can people living with and beyond colorectal cancer make lifestyle changes with the support of health technology
Behavioral: Lifestyle changes with the support of health technology
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.
- 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. [ Time Frame: Week 2 after patient recruitment ]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.
- To examine the demographics of people with CRC who are willing to participate in a study focused on lifestyle changes [ Time Frame: Week 1 after patient recruitment ]The demographics including but not limited to age and gender of patients
- To ascertain the proportion of CRC patients willing to interact with the intervention [ Time Frame: Week 5 after patient recruitment ]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.
- To identify participant reported barriers and acceptability of the use of remote reviews using telephones and digital technology [ Time Frame: study completion ]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.
- To explore the frequency of telephone contact by participants during the 2 month intervention [ Time Frame: Week 10 after patient recruitment ]The number and duration of telephone calls between dietitian and participant will also be summarized.
- To explore how much time is required for a healthcare professional to deliver the healthy diet and lifestyle intervention [ Time Frame: Study completion ]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
- To ascertain whether there was any change in diet and lifestyle factors from baseline to end of intervention (2 months) [ Time Frame: Study completion ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849352
|Contact: Victoria Aubrey, BSc, MScfirstname.lastname@example.org|
|Contact: Clare Shaw, BSc, PhD||020 7808 email@example.com|
|Principal Investigator:||Clare Shaw, BSc, PhD||Royal Marsden NHS Foundation Trust|