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Completed

NCT Number: NCT03575117

Views on Cancer Prevention and Daily Lifestyle

This study is to assess how a theoretically guided mHealth communication informed by evidence of thoughts and affect about colorectal cancer can enhance how an existing mHealth (cell/mobile based text messaging health promotion) intervention increased physical activity in healthy adults.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Merced

Merced, California, 95340, United States

About this study

Guided by the Common-Sense Model (CSM) of self-regulation and informed by prior evidence or knowledge about cancer beliefs and response to cancer risk, the investigators have now developed a complementary text and imagery based health communication called CSM--Be Well. During 2017, researchers completed three waves of data collection and pilot research that included: (a) cognitive interviews during Spring 2017, (b) manipulation check of initial health communication during Summer 2017, and (c) manipulation and quality check of final draft of health communication during Fall 2017. In this process and guided by the CSM, the investigators have developed a library of text and images (CSM--Be Well) based on information that increases understanding of colorectal cancer risk and promotes physical activity as a protective behavior against colorectal cancer. CSM--Be Well has been created as 36-slide presentation. In addition, each slide serves as a daily text message.

The purpose of the present research is to evaluate the appropriateness of our final CSM--Be Well health communication and how it enhances the National Cancer Society's HealthyYouTXT--Get Active (HYT--GA) program. To examine how well it increases understanding colorectal cancer risk and promotes physical activity, it will be compared to usual care information based on the American Cancer Society's (ACS) usual messages promoting cancer prevention and protective behaviors (i.e., physical activity, diet, and alcohol intake).

The research design is a 6-week, longitudinal, randomized control trial with two arms: experimental and control. All participants are asked to sign up for HYT--GA 6-week text messaging program. The experimental arm will view the CSM--Be Well program as a slide presentation on a website. Also, they will receive a daily drip campaign of the parsed slides that were seen at baseline activities. The control arm will view the ACS usual text as a slide presentation on a website.

In addition, the investigators will conduct surveys to evaluate the appropriateness of the theoretical framework on which the CSM--Be Well program is based. Participants will be asked to complete surveys at 8 timepoints. At enrollment (Baseline; Timepoint 1), participants will be invited to view, 2 to 3 days later (Timepoint 2), an informational session on colorectal cancer prevention and physical activity (CSM--Be Well or ACS usual messages) and to sign-up for a 6-weeks daily text messages (HYT--GA). In addition, researcher will conduct surveys to evaluate responses and user engagement. After 1 week (Timepoint 3), participants will be invited to complete surveys with measures of their understanding of colorectal cancer risk, measures of coherent understanding of colorectal cancer, physical activity behavior in the past week and future plans, and risks, concerns, and worries about colorectal cancer risk. These survey responses will be used to compare how values and self-regulation factors distinctively predict physical activity motivations and behaviors. After 2 weeks (Timepoints 3 to7), participants will be asked 5 times to a weekly brief surveys about their past and future physical activity levels. After 6 weeks (Timepoint 8), participants will be invited to complete final survey with measures of their understanding of colorectal cancer risk, measures of coherent understanding of colorectal cancer, physical activity behavior in the past week and future plans, and risks, concerns, and worries about colorectal cancer risk.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Open to all interested who are 18 years of age and older, all genders, all ethnic and/or racial identities, and regardless of health status.
  • Capacity to engage in physical active without medical and/or assisted supervision. During screening, this will be assessed by the Physical Activity Readiness (PAR-Q) survey. It confirms capacity to engage in physical activity that does not need to be medically/professionally supervised.
  • Has interest and ability to receive Short Message Service (SMS) text messages linked to a cell phone and access to the internet for information that is web based.
  • Individuals who report light/moderate physically active and sedentary lifestyles (<6.0 METs). METs are the metabolic equivalents that measures the energy related to physical activity and/or sedentary behavior.
  • Interest in wearing a pedometer.

Exclusion criteria

  • Reports of vigorous levels of physical activity. Specifically, those who report >6.0 METs. METs are the metabolic equivalents that measures the energy related to physical activity and/or sedentary behavior.
  • Those who report that a medical doctor has recommended anytime with the last 12 months that there be limited physical activity due to heart disease, pain, physical ailments, dizziness, loss of consciousness, bone/joint problems related to engaging in physical activity.
  • Those who report that a doctor recommended against engaging in supervised physical activity and/or moderate physical activity (such as walking, riding a bicycle, or mowing the lawn).

Treatment and study plan

Common-Sense Model (CSM) Be Well

Behavioral

Theoretically informed text messages and images that cover how physical activity is linked to decreasing colorectal cancer risk.

ACS usual messages

Behavioral

Information distributed by the American Cancer Society as information on the link between physical activity and cancer risk (source: www.cancer.org)

NCI HealthyYouTXT--Get Active (HYT--GA)

Behavioral

Text messaging program developed by National Cancer Society (NCI). It is a free SMS program that promotes physical activity.

Primary outcomes

  1. Change in physical active level

    Time frame: 6 weeks

    Change from physically active levels in METs at 6 weeks

Secondary outcomes

  1. Change in colorectal cancer risk and physical activity coherence

    Time frame: 6 weeks

    Change in understanding of the link between colorectal cancer risk and levels of physical activity

Sponsors and collaborators

Lead sponsor

University of California, Merced

Other

Registry information

Official study title

Views on Colorectal Cancer Beliefs, Colorectal Cancer Worry, and Physical Activity

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jul 2, 2018
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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