Behavioral Risks of CancerNCT04269018
The Effect of Mobile Text Message on Behavioral Risks of Cancer: A Randomized Controlled Trial
A study testing Cancer specific Mobile text message and General health messages in people with Behavioral Risks of Cancer, run by Wollo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavioral Risks of Cancer
- What is being tested?
- Cancer specific Mobile text message and General health messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 15 May 2020
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- College students aged 18 to 35
Who cannot join
- Mental and physical disability, those who already have diagnosed cancer
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Mobile Text Message on Behavioral Risks of Cancer Among College Students, Northeast Ethiopia: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Behavioral Risks of Cancer
- Being tested
- Cancer specific Mobile text message, General health messages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer specific Mobile text messageBehavioural
The intervention is cancer specific lifestyle mobile text messages daily for 2 months
General health messagesBehavioural
Daily text related with general health message
| Study group | Role | What they receive |
|---|---|---|
| Cancer specific Mobile text message | Experimental | This arm will receive daily mobile text message related with cancer risks and prevention Receives: Behavioral: Cancer specific Mobile text message |
| general health messages | Active comparator | This arm will receive general health message once a week Receives: Behavioral: General health messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: on average 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion15 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Behavioral Risks of CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wollo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Foziya Mohammed Hussien, Wollo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269018
- Sponsor's protocol ID
- 24
- Status last verified
- Feb 2020
- First submitted
- 9 Feb 2020
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hussien FM, Hassen AM, Asfaw ZA, Ahmed AY, Dawed YA, Asfaw AH, Amsalu ET, Hassen HY. Knowledge and practice regarding the behavioural risks of cancer among college students in Ethiopia. Ecancermedicalscience. 2022 Jan 13;16:1343. doi: 10.3332/ecancer.2022.1343. eCollection 2022.
PubMed 35242224Hussien FM, Hassen AM, Asfaw ZA, Ahmed AY, Hassen HY. The effect of mobile text messages on knowledge and perception towards cancer and behavioral risks among college students, Northeast Ethiopia: A randomized controlled trial protocol. PLoS One. 2021 Jul 9;16(7):e0253839. doi: 10.1371/journal.pone.0253839. eCollection 2021.
PubMed 34242256
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Text Message on Behavioral Risks of Cancer Among College Students, Northeast Ethiopia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04269018
- Acronym / sponsor ID
- 24
- Conditions
- Behavioral Risks of Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Wollo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 15 May 2020 (estimated)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cancer specific Mobile text message | Experimental | Behavioral: Cancer specific Mobile text messageThis arm will receive daily mobile text message related with cancer risks and prevention |
| general health messages | Active comparator | Behavioral: General health messagesThis arm will receive general health message once a week |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- College students aged 18 to 35
Key exclusion criteria (1 listed)
- Mental and physical disability, those who already have diagnosed cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cancer specific Mobile text messageThe intervention is cancer specific lifestyle mobile text messages daily for 2 months | Behavioural | Cancer specific Mobile text message |
| General health messagesDaily text related with general health message | Behavioural | general health messages |
Primary outcome
Physical activity level
Time frame: on average 6 months
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).
Health dietary score
Time frame: on average 6 months
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.
Tobacco use
Time frame: on average 6 months
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.
Alcohol intake
Time frame: on average 6 months
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.
Risk perception
Time frame: on average 6 months
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".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Derived from this study: PubMed 35242224Hussien FM, Hassen AM, Asfaw ZA, Ahmed AY, Dawed YA, Asfaw AH, Amsalu ET, Hassen HY. Knowledge and practice regarding the behavioural risks of cancer among college students in Ethiopia. Ecancermedicalscience. 2022 Jan 13;16:1343. doi: 10.3332/ecancer.2022.1343. eCollection 2022.
- Derived from this study: PubMed 34242256Hussien FM, Hassen AM, Asfaw ZA, Ahmed AY, Hassen HY. The effect of mobile text messages on knowledge and perception towards cancer and behavioral risks among college students, Northeast Ethiopia: A randomized controlled trial protocol. PLoS One. 2021 Jul 9;16(7):e0253839. doi: 10.1371/journal.pone.0253839. eCollection 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer specific Mobile text message and General health messages in people with Behavioral Risks of Cancer, run by Wollo University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Foziya Hussien, MPH (+251913714985, foziyamohammed2018@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity level (time frame: on average 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04269018, which also lists 2 linked publications.
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 21 Feb 2020.