Lifestyle Changes Using Digital Technology in Colorectal Cancer
Primary Purpose
Life Style, Colo-rectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle changes with the support of health technology
Sponsored by
About this trial
This is an interventional basic science trial for Life Style
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Lifestyle Arm
Arm Description
Can people living with and beyond colorectal cancer make lifestyle changes with the support of health technology
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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.
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.
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
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
Full Information
NCT ID
NCT03849352
First Posted
February 18, 2019
Last Updated
February 19, 2019
Sponsor
Royal Marsden NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03849352
Brief Title
Lifestyle Changes Using Digital Technology in Colorectal Cancer
Official Title
Can People Living With and Beyond Colorectal Cancer Make Lifestyle Changes With the Support of Health Technology
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 18, 2019 (Anticipated)
Primary Completion Date
May 3, 2019 (Anticipated)
Study Completion Date
June 14, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Marsden NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Life Style, Colo-rectal Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Arm
Arm Type
Other
Arm Description
Can people living with and beyond colorectal cancer make lifestyle changes with the support of health technology
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle changes with the support of health technology
Intervention Description
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 Measure Information:
Title
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.
Description
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.
Time Frame
Week 2 after patient recruitment
Secondary Outcome Measure Information:
Title
To examine the demographics of people with CRC who are willing to participate in a study focused on lifestyle changes
Description
The demographics including but not limited to age and gender of patients
Time Frame
Week 1 after patient recruitment
Title
To ascertain the proportion of CRC patients willing to interact with the intervention
Description
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.
Time Frame
Week 5 after patient recruitment
Title
To identify participant reported barriers and acceptability of the use of remote reviews using telephones and digital technology
Description
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.
Time Frame
study completion
Title
To explore the frequency of telephone contact by participants during the 2 month intervention
Description
The number and duration of telephone calls between dietitian and participant will also be summarized.
Time Frame
Week 10 after patient recruitment
Title
To explore how much time is required for a healthcare professional to deliver the healthy diet and lifestyle intervention
Description
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
Time Frame
Study completion
Title
To ascertain whether there was any change in diet and lifestyle factors from baseline to end of intervention (2 months)
Description
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
Time Frame
Study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Aubrey, BSc, MSc
Phone
07841026848
Email
victoria.aubrey@rmh.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Clare Shaw, BSc, PhD
Phone
020 7808 2819
Email
clare.shaw@rmh.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clare Shaw, BSc, PhD
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Lifestyle Changes Using Digital Technology in Colorectal Cancer
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