Lifestyle Changes Using Digital Technology in Colorectal Cancer
Can People Living With and Beyond Colorectal Cancer Make Lifestyle Changes With the Support of Health Technology
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:基礎科学
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の:Lifestyle Arm
Can people living with and beyond colorectal cancer make 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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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.
時間枠: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.
|
Week 2 after patient recruitment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To examine the demographics of people with CRC who are willing to participate in a study focused on lifestyle changes
時間枠:Week 1 after patient recruitment
|
The demographics including but not limited to age and gender of patients
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Week 1 after patient recruitment
|
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To ascertain the proportion of CRC patients willing to interact with the intervention
時間枠:Week 5 after patient recruitment
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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.
|
Week 5 after patient recruitment
|
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To identify participant reported barriers and acceptability of the use of remote reviews using telephones and digital technology
時間枠: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.
|
study completion
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To explore the frequency of telephone contact by participants during the 2 month intervention
時間枠:Week 10 after patient recruitment
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The number and duration of telephone calls between dietitian and participant will also be summarized.
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Week 10 after patient recruitment
|
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To explore how much time is required for a healthcare professional to deliver the healthy diet and lifestyle intervention
時間枠: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
|
Study completion
|
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To ascertain whether there was any change in diet and lifestyle factors from baseline to end of intervention (2 months)
時間枠: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
|
Study completion
|
協力者と研究者
捜査官
- 主任研究者:Clare Shaw, BSc, PhD、Royal Marsden NHS Foundation Trust
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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