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Lifestyle Changes Using Digital Technology in Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03849352
Recruitment Status : Not yet recruiting
First Posted : February 21, 2019
Last Update Posted : February 21, 2019
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Life Style Colo-rectal Cancer Behavioral: Lifestyle changes with the support of health technology Not Applicable

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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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Lifestyle Arm
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.

Primary Outcome Measures :
  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. [ 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.

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03849352

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Contact: Victoria Aubrey, BSc, MSc 07841026848
Contact: Clare Shaw, BSc, PhD 020 7808 2819

Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
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Principal Investigator: Clare Shaw, BSc, PhD Royal Marsden NHS Foundation Trust

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Responsible Party: Royal Marsden NHS Foundation Trust Identifier: NCT03849352     History of Changes
Other Study ID Numbers: CCR5040
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases