NCT04269018

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

February 9, 2020

Last Update Submit

February 19, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

Cancer specific Mobile text message

EXPERIMENTAL

This arm will receive daily mobile text message related with cancer risks and prevention

Behavioral: Cancer specific Mobile text message

general health messages

ACTIVE COMPARATOR

This arm will receive general health message once a week

Behavioral: General health messages

Interventions

The intervention is cancer specific lifestyle mobile text messages daily for 2 months

Cancer specific Mobile text message

Daily text related with general health message

general health messages

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • College students aged 18 to 35

You may not qualify if:

  • Mental and physical disability, those who already have diagnosed cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • Hussien 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.

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
To maintain blinding, randomization will occur after the baseline assessment and both groups will receive welcome message for participating in the study. Then motivational and general healthy related texts will be delivered to controls one times per week.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

February 9, 2020

First Posted

February 13, 2020

Study Start

March 1, 2020

Primary Completion

April 30, 2020

Study Completion

May 15, 2020

Last Updated

February 21, 2020

Record last verified: 2020-02