The Effect of Mobile Text Message on Behavioral Risks of Cancer: A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Summary Background: Cancer is a public health problem in Ethiopia. A third of cancer deaths are preventable. Its effects can be significantly reduced if effective interventions are put in place to control risk factors. Text-messaging has been currently targeted as a simple tool for providing people with health information. Thus this study aimed to measure the effectiveness of text message in behavioral risk factors that is helpful to raise cancer awareness and promote cancer prevention and control in this country. Methods: A randomized control trial will be used to measure the effectiveness of mobile text message in behavioral risk factor of cancer among Governmental Collage students in Dessie City and utilize quantitative method of data collection. Data will be collected on a total of 80 intervention and 80 controls using structured questionnaire. Socio-demographic, health belief variables and behavioral risk factor of cancer will be collected before and after intervention. Text message will be provided based on health belief model. Data will be entered using Epidata version 3.1 and will be exported to STATA version 13.0 for cleaning and analysis. Liner regression will be applied to identify predictors of behavioral risk factor of cancer. Student's paired samples t-test will be used to test changes in terms of HBM variables and behavioural outcomes. Analysis of Covariance will be used to test over group comparison.

Detailed Description
-----------------
The study will be a single blind randomized controlled trial, which utilize quantitative method of data collection. College students who will receive a mobile text message about the behavioral risks of cancer and prevention mechanism will be considered as intervention groups while controls will be those who receive a text message related with general health once a week. A total of 160 (80 interventions and 80 controls) students will be included in the study using simple random sampling technique. After the baseline assessment, participants will be randomized to either usual care (control) or the text message intervention group in a uniform 1:1 (control: intervention) allocation ratio, using computer-based randomization service. Self-administered questionnaire will be used to assess baseline and end line data of behavioral risk factors and other variables. Participants in the control group will receive an initial text message welcoming them to the study, but they will not receive the text message support program. The intervention group will receive a text message support program, where they will receive seven messages per week at random times and days for two months. The text message will be prepared and delivered based on health belief model (HBM), the items of this subscale will be measured on a Likert scale ranging from 1= Strongly disagree to 5 = Strongly agree. Tobacco use, harmful use of alcohol, unhealthy diet and physical inactivity with a series of items will be used to measure the behavioral outcomes the items in this subscale will be measured on a Likert scale. Validity of the items will be measured by an expert panel of specialists in health education and nutrition. They will judge about the necessity and relevance of the scale items. To control the data quality all data collectors will be trained for two days. Supervisors will monitor data collection process and the principal investigator will visit frequently. The questionnaire will be first prepared in English language and translated to Amharic and again re-translated in to English by another person to check for consistency. About 10% of the questionnaire will be pretested and internal consistency will be checked. Completeness of the collected data will be checked during data collection. The data will be checked for completeness and consistency, then categorized, coded and entered using Epidata version 3.1 to minimize error. Then, the clean data will be exported to Stata version 14 for analysis. Normality of the data will be checked through Kolmogorov-Smirnov test. Student's paired samples t-test will be used to test within-group changes in terms of health belief model (HBM) variables and behavioral outcomes. The analysis of Covariance will be used to make over-group comparisons. Data will be reported as mean ± standard deviation. The significance level for all of the results will be presented at the P<0.05 level.

Official Title
-----------------
The Effect of Mobile Text Message on Behavioral Risks of Cancer Among College Students, Northeast Ethiopia: A Randomized Controlled Trial

Conditions
-----------------
Behavioral Risks of Cancer

Intervention / Treatment
-----------------
* Behavioral: Cancer specific Mobile text message
* Behavioral: General health messages


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: College students aged 18 to 35 Exclusion Criteria: Mental and physical disability, those who already have diagnosed cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to intervention and control group, the intervention group will be received daily text message while the controls will receive general health messages once a week.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cancer specific Mobile text message<br>This arm will receive daily mobile text message related with cancer risks and prevention | Behavioral: Cancer specific Mobile text message<br>* The intervention is cancer specific lifestyle mobile text messages daily for 2 months<br>|
| Active Comparator: general health messages<br>This arm will receive general health message once a week | Behavioral: General health messages<br>* Daily text related with general health message<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity level | For measuring physical activity International Physical Activity Questionnaires (IPAQ) will be used. The questions will ask the time study participants spent being physically active in the last 7 days. Then, it will be summarized as Metabolic Equivalents (METs). | on average 6 months | 
| Health dietary score | Healthy diet score will be assessed the health diet score adapted from the WHO list of healthy diet foods, which is a Likert scale ranged from 1 to 6. | on average 6 months | 
| Tobacco use | Tobacco smoking will be assessed using a series of questions adopted from the World Health Organization (WHO), which used to assess the duration, quantity and frequency of smoking within one month. | on average 6 months | 
| Alcohol intake | Alcohol consumption will be assessed using a tool adopted from National Institute on Alcohol Abuse and Alcoholism (NIAAA), which used to assess participants consumption in the past 1 month. | on average 6 months | 
| Risk perception | Risk perception will be measured using health belief model variables: perceived susceptibility towards cancer, perceived severity of cancer, perceived benefits of adopting behaviors, perceived barriers to adopting behaviors, perceived self-efficacy for adopting dietary behaviors and internal cues for adopting dietary behaviors, the items of this subscale will be measured on a Likert scale ranging from 1= Strongly disagree to 5 = Strongly agree. | on average 6 months |