Clinical trial NCT02837159: A Mobile Aplication for the Promotion of Healthy Lifestyle Habits in Patients With Colorectal Cancer
Official title: Effectiveness of a Mobile Application for the Promotion of Healthy Lifestyle Habits in Patients With Colorectal Cancer: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: colorectal cancer
Health Life Style Habits
Health
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2016-07-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized study is to assess the efficacy of a mobile application for the promotion of healthy lifestyle habits (diet and exercise) in colorectal cancer survivors (CCR).

Detailed description: Background: Among all types of cancer, colorectal cancer (CRC) is one of the most frequent, and Spain is among the countries with the highest incidence of CCR with a ratio of about 100,000 people. Fortunately the data of survival are very encouraging according to the National Cancer Institute, it is around 70% at 5 years when the cancer is regional and it could reaching up to 90% when it is more localized. During this survival, however, a high number of patients suffer physical and psychological sequelae that limited their quality of life.

This is why that, to try to minimize these effects, it is essential to try to instill healthy habits (food and physical exercise), since as it confirms the current literature, obesity is related to a lower survival and a greater presence of other diseases, and increased consumption of fruits and vegetables and physical activity practice improves the quality of life in survivors of CRC. However, changes in lifestyle are complicated to maintain long-term. In this sense, the technological development offers possibilities to try to resolve this lack of adherence in patients with cancer. However, the evidence highlights the need to improve knowledge about its applicability and efficacy in patients with this pathology betting on technologies more innovative.

Objective: The purpose of this randomized study is to assess the efficacy of a mobile application for the promotion of healthy lifestyle habits (diet and exercise) in CRC survivors. In a more specific way, analyze the effectiveness of the implementation to maintain healthy lifestyle habits in patients newly diagnosed with CRC through adherence to a healthy lifestyle (exercise and diet), as well as facilitate changes in clinical variables: body composition, quality of life, physical condition related to health (functional ability, strength and flexibility).

Methods: 54 patients will be recruited from the Virgen de las Nieves Hospital from Granada (Spain). Patients will be randomized in two groups: control and experimental group. The assessment of the end points will be made in IMUDS (Instituto Mixto Deporte y Salud) from Granada (Spain) at three moments: at baseline, at 8 weeks (at the end of the program) and at 12 months of follow-up. The intervention will consist in: 1)Feedback daily or weekly of physical exercise and diet through the application (notice) according to the records of diet and exercise and following recommendations of International Organizations 2) Participation in three sessions of seminars (1 hour each every 15 days) on habits of life healthy and cancer and the self-regulation through measurements performed by the application 3) Calls weekly to the patients of way individual to comment possible errors or doubts about the application, of 10 min of duration (8 calls). The control group will follow the usual indications of their oncologist and completion of the study will be offered access to the application.

Discussion: Health mobile applications (mobile health, mHealth) are potential tools to address the needs of cancer patients, because it enabling personalized interventions and the adherence to them. Previous studies have showed: 1) Are effective for weight loss in people with obesity or overweight. 2) You can count on are to promote a healthy lifestyle focused on the loss of weight in cancer patients. 3) Strategies based on self-regulation will not only improve the regulation of the exercise by the patient, but they also produce a greater adherence to the same. However, despite all these advances, are few them studies that have analyzed the efficiency of mobile applications as tool appropriate for foster the acquisition of habits of life healthy in cancer patients. Therefore are necessary studies that improve the adequacy of interventions to the needs of patients with CRC with support from technologies that show its effectiveness.

Eligibility criteria: Inclusion Criteria:

* Have a diagnosed of colorectal cancer (estadio I-IIIa)
* Have finished the primary medical treatment.
* Have a body mass index \> 25
* Have a level of physical activity \< 3 METS
* Have access to a Smartphone

Exclusion Criteria:

* Physical effort Contraindication from their oncologist
* Anemia
* Presence of pathologies that make more difficult the practice of physical activity such as osteoarthritis.
* Inability to read
* Severe depression, physical deficits or cognitive
* Participation in any program or intervention for weight control

Primary outcomes:
measure: Body Mass Index
timeFrame: Participants will be followed over 12 months
Secondary outcomes:
measure: Fat mass
timeFrame: Patients will be followed over 12 months
measure: Wait circunferemce
timeFrame: Patients will be followed over 12 months
measure: Hip circunferemce
timeFrame: Patients will be followed over 12 months
measure: Expenditure energy
timeFrame: Patients will be followed over 12 months
measure: Eating habits
timeFrame: Patients will be followed over 12 months
measure: Cardiorespiratory fitness
timeFrame: Patients will be followed over 12 months
measure: Isometric abdominal strength
timeFrame: Patients will be followed over 12 months
measure: Lower-body flexibility
timeFrame: Patients will be followed over 12 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Universidad de Granada
Study officials:
affiliation: Universidad de Granada
name: IRENE CANTARERO VILLANUEVA, PhD
role: PRINCIPAL_INVESTIGATOR
References: