Life StyleNCT03849352
Lifestyle Changes Using Digital Technology in Colorectal Cancer
A study testing Lifestyle changes with the support of health technology in people with Life Style and Colo-rectal Cancer, run by Royal Marsden NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Life Style, Colo-rectal Cancer
- What is being tested?
- Lifestyle changes with the support of health technology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 18 Mar 2019to 14 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Life Style, Colo-rectal Cancer
- Being tested
- Lifestyle changes with the support of health technology
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle changes with the support of health technologyBehavioural
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 group | Role | What they receive |
|---|---|---|
| Lifestyle Arm | Other | Can people living with and beyond colorectal cancer make lifestyle changes with the support of health technology Receives: Behavioral: Lifestyle changes with the support of health technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 2 after patient recruitment
Secondary outcomes (6)
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
Measured: Week 1 after patient recruitment
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.
Measured: Week 5 after patient recruitment
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.
Measured: study completion
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.
Measured: Week 10 after patient recruitment
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
Measured: Study completion
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
Measured: Study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start18 Mar 2019 (estimated)
- Primary completion3 May 2019 (estimated)
- Study completion14 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Life StyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clare Shaw, BSc, PhD, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849352
- Sponsor's protocol ID
- CCR5040
- Status last verified
- Feb 2019
- First submitted
- 18 Feb 2019
- Last updated
- 21 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nelson V, Cross AJ, Powell J, Shaw C. Can people living with and beyond colorectal cancer make lifestyle changes with the support of health technology: A feasibility study. J Hum Nutr Diet. 2023 Apr;36(2):554-565. doi: 10.1111/jhn.13008. Epub 2022 Apr 9.
PubMed 35320595
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can People Living With and Beyond Colorectal Cancer Make Lifestyle Changes With the Support of Health Technology
- ClinicalTrials.gov ID
- NCT03849352
- Acronym / sponsor ID
- CCR5040
- Conditions
- Life Style, Colo-rectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 18 Mar 2019 (estimated)
- Primary completion
- 3 May 2019 (estimated)
- Study completion
- 14 Jun 2019 (estimated)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Arm | Other | Behavioral: Lifestyle changes with the support of health technologyCan people living with and beyond colorectal cancer make lifestyle changes with the support of health technology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle changes with the support of health technologyWritten 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. | Behavioural | Lifestyle Arm |
Primary outcome
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.
6 secondary outcomes
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
To ascertain the proportion of CRC patients willing to interact with the intervention
Time frame: Week 5 after patient recruitment
To identify participant reported barriers and acceptability of the use of remote reviews using telephones and digital technology
Time frame: study completion
To explore the frequency of telephone contact by participants during the 2 month intervention
Time frame: Week 10 after patient recruitment
To explore how much time is required for a healthcare professional to deliver the healthy diet and lifestyle intervention
Time frame: Study completion
To ascertain whether there was any change in diet and lifestyle factors from baseline to end of intervention (2 months)
Time frame: Study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Derived from this study: PubMed 35320595Nelson V, Cross AJ, Powell J, Shaw C. Can people living with and beyond colorectal cancer make lifestyle changes with the support of health technology: A feasibility study. J Hum Nutr Diet. 2023 Apr;36(2):554-565. doi: 10.1111/jhn.13008. Epub 2022 Apr 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clare Shaw, BSc, PhD principal investigator
Royal Marsden NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle changes with the support of health technology in people with Life Style and Colo-rectal Cancer, run by Royal Marsden NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victoria Aubrey, BSc, MSc (07841026848, victoria.aubrey@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03849352, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.