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

Primary Purpose

Colorectal Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
mHealth application
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer, Health Life Style Habits, Health

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad de Granada

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

mHealth application

Usual care

Arm Description

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).

Usual care

Outcomes

Primary Outcome Measures

Body Mass Index
in kg/m2, will be assessed by conducting Dual-energy X-ray absorptiometry (DXA, discovery densitometer from HOLOGIC, QDR 4500W)

Secondary Outcome Measures

Fat mass
Fat mass (%): will be evaluated by conducting Dual-energy X-ray absorptiometry (DXA, discovery densitometer from HOLOGIC, QDR 4500W)
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.
Hip circunferemce
It will be measured with a plastic tape. Hip circumference was measured at the level of the greater trochanter.
Expenditure energy
it will be assessed though FITBIT CHARGE HR bracelet in kcal/day.
Eating habits
through a record of 24-hour, recording the amount of macronutrients (carbohydrates, lipids, proteins), micronutrients (vitamins and minerals), fiber and energy density.
Cardiorespiratory fitness
the 6 minutes walking test will be used to measure the distance (m) that patients could walk in 6 minutes.
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.
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.

Full Information

First Posted
July 14, 2016
Last Updated
May 25, 2022
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT02837159
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
removal of the Phd student due to not obtaining financing
Study Start Date
October 2016 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, Health Life Style Habits, Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mHealth application
Arm Type
Experimental
Arm Description
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).
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
mHealth application
Intervention Description
Dietary and physical activity recommendations trough a mobile application
Primary Outcome Measure Information:
Title
Body Mass Index
Description
in kg/m2, will be assessed by conducting Dual-energy X-ray absorptiometry (DXA, discovery densitometer from HOLOGIC, QDR 4500W)
Time Frame
Participants will be followed over 12 months
Secondary Outcome Measure Information:
Title
Fat mass
Description
Fat mass (%): will be evaluated by conducting Dual-energy X-ray absorptiometry (DXA, discovery densitometer from HOLOGIC, QDR 4500W)
Time Frame
Patients will be followed over 12 months
Title
Wait circunferemce
Description
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.
Time Frame
Patients will be followed over 12 months
Title
Hip circunferemce
Description
It will be measured with a plastic tape. Hip circumference was measured at the level of the greater trochanter.
Time Frame
Patients will be followed over 12 months
Title
Expenditure energy
Description
it will be assessed though FITBIT CHARGE HR bracelet in kcal/day.
Time Frame
Patients will be followed over 12 months
Title
Eating habits
Description
through a record of 24-hour, recording the amount of macronutrients (carbohydrates, lipids, proteins), micronutrients (vitamins and minerals), fiber and energy density.
Time Frame
Patients will be followed over 12 months
Title
Cardiorespiratory fitness
Description
the 6 minutes walking test will be used to measure the distance (m) that patients could walk in 6 minutes.
Time Frame
Patients will be followed over 12 months
Title
Isometric abdominal strength
Description
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.
Time Frame
Patients will be followed over 12 months
Title
Lower-body flexibility
Description
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.
Time Frame
Patients will be followed over 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
IRENE CANTARERO VILLANUEVA, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Granada
City
Granada
ZIP/Postal Code
18016
Country
Spain

12. IPD Sharing Statement

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

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