A Mobile Aplication for the Promotion of Healthy Lifestyle Habits in Patients With Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of a Mobile Application for the Promotion of Healthy Lifestyle Habits in Patients With Colorectal Cancer: a Randomized Controlled Trial

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: mHealth application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mHealth application<br>The assessment of the end points will be made 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). | Other: mHealth application<br>* Dietary and physical activity recommendations trough a mobile application<br>|
| No Intervention: Usual care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index | in kg/m2, will be assessed by conducting Dual-energy X-ray absorptiometry (DXA, discovery densitometer from HOLOGIC, QDR 4500W) | Participants will be followed over 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat mass | Fat mass (%): will be evaluated by conducting Dual-energy X-ray absorptiometry (DXA, discovery densitometer from HOLOGIC, QDR 4500W) | Patients will be followed over 12 months | 
| Wait circunferemce | It will be measured with a plastic tape. Waist circumference was assessed midway between the lower rib margin and the top of the iliac crest (cm) at the end of normal breathing. | Patients will be followed over 12 months | 
| Hip circunferemce | It will be measured with a plastic tape. Hip circumference was measured at the level of the greater trochanter. | Patients will be followed over 12 months | 
| Expenditure energy | it will be assessed though FITBIT CHARGE HR bracelet in kcal/day. | Patients will be followed over 12 months | 
| Eating habits | through a record of 24-hour, recording the amount of macronutrients (carbohydrates, lipids, proteins), micronutrients (vitamins and minerals), fiber and energy density. | Patients will be followed over 12 months | 
| Cardiorespiratory fitness | the 6 minutes walking test will be used to measure the distance (m) that patients could walk in 6 minutes. | Patients will be followed over 12 months | 
| Isometric abdominal strength | it will be assessed with trunk curl test. Patient through a trunk curl has to keep an isometric position separating the inferior angle of the scapulae from the stretcher as long as possible until 90 seconds as maximum. | Patients will be followed over 12 months | 
| Lower-body flexibility | it will be assessed with chair sit and reach test. Patients were instructed to slide their hands as long as possible to touch their toes. The centimeters that were missing (minus score) or exceeded(plus score) from the tip of the foot were registered. | Patients will be followed over 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health, colorectal cancer, Health Life Style Habits