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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
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE February 18, 2019
First Posted Date  ICMJE February 21, 2019
Last Update Posted Date February 21, 2019
Estimated Study Start Date  ICMJE March 18, 2019
Estimated Primary Completion Date May 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifestyle Changes Using Digital Technology in Colorectal Cancer
Official Title  ICMJE Can People Living With and Beyond Colorectal Cancer Make Lifestyle Changes With the Support of Health Technology
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.
Detailed Description

Fifty four percent of Colorectal cancer (CRC) cases are thought to be preventable, showing it has a strong correlation with lifestyle factors. A recent report by the World Cancer Research Fund and American Institute of Cancer Research (WCRF/AICR) on diet, physical activity (PA) and CRC reported numerous findings linking lifestyle with primary prevention of CRC. Approximately six out of ten people diagnosed with bowel cancer in England and Wales survive for 10-years or more and rates of survival have more than doubled in the last 40-years.

The term 'cancer survivors' denotes all people who are living with a diagnosis of cancer, and those who have recovered from the disease. The term is not universally accepted and survivors are increasingly being referred to as people 'living with and beyond cancer. This covers a wide variety of circumstances including people at diagnosis, during and post treatment, and those with recurrence therefore including people with potentially differing nutritional needs. People can be struggling with a poor nutritional intake due to treatment side effects or may need to optimise their nutritional status preoperatively or require advice post treatment for optimum recovery and rehabilitation. However, compared to the vast amount of research with respect to CRC incidence there is a paucity of research on diet and lifestyle factors influencing CRC recurrence and survival.

The second WCRF and AICR expert report in 2007 undertook a systematic literature review to assess the role of food, nutrition and PA in people diagnosed with cancer. The report included randomized control trials (RCTs) evaluating dietary interventions, however, there were no conclusions drawn. This was attributed to poor quality designs and varying intervention duration of the studies. The third WCRF and AICR expert report, in 2018, stated new evidence had accrued since the second report but primarily within breast cancer therefore a review of the evidence was undertaken in this group leaving a gap in the evidence base with regard to CRC.

The design of secondary prevention studies are based on expert conclusion with the third WCRF recommending survivors who have completed treatment should follow the general advice for cancer prevention. The current strongest primary prevention evidence is that CRC risk is decreased by being physically active in addition to a higher consumption of wholegrains, dietary fibre and dairy products. Risk is increased by the consumption of red and processed meat, more than two alcoholic drinks per day and being overweight or obese.

A recent review of the literature of lifestyle interventions in RCTs in people with CRC has identified 6 published studies (in preparation). The review identified that all current studies used a variety of dietary and physical activity interventions, data collection tools and inconsistent timing of interventions commencing from 6 months to 5 years post diagnosis. None of the published RCTs achieved changes in dietary intake and any small changes that occurred were not sustainable with participants reverting to their usual dietary habits.

One conclusion from the review was that no studies used appropriate methods to support behaviour change such as healthcare professionals trained in behaviour change techniques and methods of support, for example, digital technology. It has been demonstrated that such techniques would help support people to make lifestyle changes and from a research perspective can eliminate administration-intensive tasks, variation in interpretation and recording errors

Discussion with the PPI group of The Royal Marsden Hospital (NHS Foundation Trust) and Institute of Cancer Research provided a valuable insight into the variance in opinion as to when and how people could be asked to make lifestyle changes. The support provided by family members and / or carers was identified as a critical factor in supporting people to make lifestyle changes.

There has recently been an increased interest in the use of digital behaviour change interventions (DBCIs) and smartphone applications in the healthcare setting, including in the management of diet, PA and weight.

A recent systematic review of DBCIs amongst cancer survivors identified fifteen studies and concluded DBCIs can improve PA and Body Mass Index (BMI), in this patient group, with mixed results for improved dietary behaviours.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Life Style
  • Colo-rectal Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE Lifestyle Arm
Can people living with and beyond colorectal cancer make lifestyle changes with the support of health technology
Intervention: Behavioral: Lifestyle changes with the support of health technology
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 19, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 14, 2019
Estimated Primary Completion Date May 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Victoria Aubrey, BSc, MSc 07841026848 victoria.aubrey@rmh.nhs.uk
Contact: Clare Shaw, BSc, PhD 020 7808 2819 clare.shaw@rmh.nhs.uk
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03849352
Other Study ID Numbers  ICMJE CCR5040
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Royal Marsden NHS Foundation Trust
Study Sponsor  ICMJE Royal Marsden NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Clare Shaw, BSc, PhD Royal Marsden NHS Foundation Trust
PRS Account Royal Marsden NHS Foundation Trust
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP