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临床试验/NCT03849352
NCT03849352Unknown不适用

Can People Living With and Beyond Colorectal Cancer Make Lifestyle Changes With the Support of Health Technology

Royal Marsden NHS Foundation Trust0 个研究点目标入组 20 人开始时间: 2019年3月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Lifestyle Arm

Other

Can people living with and beyond colorectal cancer make lifestyle changes with the support of health technology

干预措施: Lifestyle changes with the support of health technology (Behavioral)

结局指标

主要结局

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.

时间窗: 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.

次要结局

  • To identify participant reported barriers and acceptability of the use of remote reviews using telephones and digital technology(study completion)
  • To examine the demographics of people with CRC who are willing to participate in a study focused on lifestyle changes(Week 1 after patient recruitment)
  • To ascertain the proportion of CRC patients willing to interact with the intervention(Week 5 after patient recruitment)
  • To explore the frequency of telephone contact by participants during the 2 month intervention(Week 10 after patient recruitment)
  • To explore how much time is required for a healthcare professional to deliver the healthy diet and lifestyle intervention(Study completion)
  • To ascertain whether there was any change in diet and lifestyle factors from baseline to end of intervention (2 months)(Study completion)

研究者

申办方类型
Other
责任方
Sponsor

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