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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02837159
Recruitment Status : Suspended (removal of the Phd student due to not obtaining financing)
First Posted : July 19, 2016
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Irene Cantarero Villanueva, Universidad de Granada

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).

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: mHealth application Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Mobile Application for the Promotion of Healthy Lifestyle Habits in Patients With Colorectal Cancer: a Randomized Controlled Trial
Study Start Date : October 2016
Actual Primary Completion Date : March 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mHealth application
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
Dietary and physical activity recommendations trough a mobile application

No Intervention: Usual care
Usual care



Primary Outcome Measures :
  1. Body Mass Index [ Time Frame: Participants will be followed over 12 months ]
    in kg/m2, will be assessed by conducting Dual-energy X-ray absorptiometry (DXA, discovery densitometer from HOLOGIC, QDR 4500W)


Secondary Outcome Measures :
  1. Fat mass [ Time Frame: Patients will be followed over 12 months ]
    Fat mass (%): will be evaluated by conducting Dual-energy X-ray absorptiometry (DXA, discovery densitometer from HOLOGIC, QDR 4500W)

  2. Wait circunferemce [ Time Frame: Patients will be followed over 12 months ]
    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.

  3. Hip circunferemce [ Time Frame: Patients will be followed over 12 months ]
    It will be measured with a plastic tape. Hip circumference was measured at the level of the greater trochanter.

  4. Expenditure energy [ Time Frame: Patients will be followed over 12 months ]
    it will be assessed though FITBIT CHARGE HR bracelet in kcal/day.

  5. Eating habits [ Time Frame: Patients will be followed over 12 months ]
    through a record of 24-hour, recording the amount of macronutrients (carbohydrates, lipids, proteins), micronutrients (vitamins and minerals), fiber and energy density.

  6. Quality of life [ Time Frame: Patients will be followed over 12 months ]
    through the questionnaire of the European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30) and the module specific to cancer of colon EORTC QLQ-CR38.

  7. Cardiorespiratory fitness [ Time Frame: Patients will be followed over 12 months ]
    the 6 minutes walking test will be used to measure the distance (m) that patients could walk in 6 minutes.

  8. Isometric abdominal strength [ Time Frame: Patients will be followed over 12 months ]
    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.

  9. Lower-body flexibility [ Time Frame: Patients will be followed over 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837159


Locations
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Spain
Universidad de Granada
Granada, Spain, 18016
Sponsors and Collaborators
Universidad de Granada
Investigators
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Principal Investigator: IRENE CANTARERO VILLANUEVA, PhD Universidad de Granada
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Responsible Party: Irene Cantarero Villanueva, Dra, Universidad de Granada
ClinicalTrials.gov Identifier: NCT02837159    
Other Study ID Numbers: CO217
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Keywords provided by Irene Cantarero Villanueva, Universidad de Granada:
colorectal cancer
Health Life Style Habits
Health
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases