AzTrials
AzTrials

Colorectal CancerNCT02837159

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

A study testing mHealth application in people with Colorectal Cancer, run by Universidad de Granada at 1 site in Spain.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Colorectal Cancer
What is being tested?
mHealth application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteSpain
Study dates
Oct 2016to Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Universidad de Granada

    Granada, 18016

Other trials in Spain

About this study

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

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).

Read the 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.

Being tested
mHealth application
Keywords
colorectal cancer, Health Life Style Habits, Health
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mHealth applicationOther

    Dietary and physical activity recommendations trough a mobile application

Study groups in NCT02837159
Study groupRoleWhat they receive
mHealth applicationExperimentalThe 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).
Receives: Other: mHealth application
Usual careNo interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Mass Index

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

    Measured: Participants will be followed over 12 months

Secondary outcomes (8)
  1. Fat mass

    Fat mass (%): will be evaluated by conducting Dual-energy X-ray absorptiometry (DXA, discovery densitometer from HOLOGIC, QDR 4500W)

    Measured: Patients will be followed over 12 months

  2. 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.

    Measured: Patients will be followed over 12 months

  3. Hip circunferemce

    It will be measured with a plastic tape. Hip circumference was measured at the level of the greater trochanter.

    Measured: Patients will be followed over 12 months

  4. Expenditure energy

    it will be assessed though FITBIT CHARGE HR bracelet in kcal/day.

    Measured: Patients will be followed over 12 months

  5. Eating habits

    through a record of 24-hour, recording the amount of macronutrients (carbohydrates, lipids, proteins), micronutrients (vitamins and minerals), fiber and energy density.

    Measured: Patients will be followed over 12 months

  6. Cardiorespiratory fitness

    the 6 minutes walking test will be used to measure the distance (m) that patients could walk in 6 minutes.

    Measured: Patients will be followed over 12 months

  7. 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.

    Measured: Patients will be followed over 12 months

  8. 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.

    Measured: Patients will be followed over 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionMar 2018
  4. Study completionSep 2019

Why it stopped: removal of the Phd student due to not obtaining financing

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02837159
Sponsor's protocol ID
CO217
Status last verified
May 2022
First submitted
14 Jul 2016
Last updated
31 May 2022
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing mHealth application in people with Colorectal Cancer, run by Universidad de Granada at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Mass Index (time frame: Participants will be followed over 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in