Colorectal CancerNCT03575117
Views on Cancer Prevention and Daily Lifestyle
A study testing Common-Sense Model (CSM) Be Well, ACS usual messages and NCI HealthyYouTXT--Get Active (HYT--GA) in people with Colorectal Cancer and Sedentary Lifestyle, run by University of California, Merced at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Sedentary Lifestyle
- What is being tested?
- Common-Sense Model (CSM) Be Well, ACS usual messages and NCI HealthyYouTXT--Get Active (HYT--GA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 31 Dec 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Merced
Merced, California, 95340
About this study
Official title: Views on Colorectal Cancer Beliefs, Colorectal Cancer Worry, and Physical Activity
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.
Read the detailed description
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.
- Conditions
- Colorectal Cancer, Sedentary Lifestyle
- Being tested
- Common-Sense Model (CSM) Be Well, ACS usual messages, NCI HealthyYouTXT--Get Active (HYT--GA)
- Medical subject headings
- Colorectal Neoplasms, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Common-Sense Model (CSM) Be WellBehavioural
Theoretically informed text messages and images that cover how physical activity is linked to decreasing colorectal cancer risk.
ACS usual messagesBehavioural
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)Behavioural
Text messaging program developed by National Cancer Society (NCI). It is a free SMS program that promotes physical activity.
| Study group | Role | What they receive |
|---|---|---|
| NCI HYT--GA + CSM--Be Well | Experimental | Participants who view the Common Sense Model (CSM) "Be Well" text and image communication will be invited to receive two sets of daily text messages: (1) one text message and one image per day and (2) National Cancer Institute (NCI) HealthyYouTXT-Get Active (HYT-GA) program that is delivered 2-5 times daily for 6 weeks. After baseline and at timepoint 2, participants will view a slide presentation with imagery and text related to colorectal cancer risk and sedentary lifestyle. The same messages will be delivered as a drip campaign alongside the NCI HYT-GA text messaging program. Receives: Behavioral: Common-Sense Model (CSM) Be Well; Behavioral: NCI HealthyYouTXT--Get Active (HYT--GA) |
| NCI HYT--GA + ACS usual messages | Other | Adapted American Cancer Society (ACS) informational messages about colorectal cancer risk and lifestyle will be invited to receive one set of daily text messages, NCI HealthyYouTXT-Get Active (HYT-GA) program that is delivered 2-5 times daily for 6 weeks. After baseline and at timepoint 2, participants will view an informational slide presentation that is based on adapted language from American Cancer Guidelines related to cancer prevention and physical activity (https://www.cancer.org/healthy/eat-healthy-get-active/acs-guidelines-nutrition-physical-activity-cancer-prevention.html). Receives: Behavioral: ACS usual messages; Behavioral: NCI HealthyYouTXT--Get Active (HYT--GA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical active level
Change from physically active levels in METs at 6 weeks
Measured: 6 weeks
Secondary outcomes (1)
Change in colorectal cancer risk and physical activity coherence
Change in understanding of the link between colorectal cancer risk and levels of physical activity
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start1 May 2018
- Primary completion15 Aug 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Merced
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Diane Cameron, University of California, Merced
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575117
- Sponsor's protocol ID
- UCM2018-1
- Status last verified
- Nov 2022
- First submitted
- 15 Mar 2018
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buhi, E. R., Trudnak, T. E., Martinasek, M. P., Oberne, A. B., Fuhrmann, H. J., & McDermott, R. J. (2013). Mobile phone-based behavioural interventions for health: A systematic review. Health Education Journal, 72, 564-583.
Cameron LD, Jago L. Emotion regulation interventions: a common-sense model approach. Br J Health Psychol. 2008 May;13(Pt 2):215-21. doi: 10.1348/135910708X288800. Epub 2008 Feb 26.
PubMed 18302809Durazo, A., & Cameron, L. D. (Manuscript in preparation). A review of cancer risk representations and affect: cancer beliefs and worry as predictors of protection motivation and behavior. Psychological Sciences. University of California, Merced.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Views on Colorectal Cancer Beliefs, Colorectal Cancer Worry, and Physical Activity
- ClinicalTrials.gov ID
- NCT03575117
- Acronym / sponsor ID
- UCM2018-1
- Conditions
- Colorectal Cancer, Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of California, MercedUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 Jul 2018 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NCI HYT--GA + CSM--Be Well | Experimental | Behavioral: Common-Sense Model (CSM) Be Well, Behavioral: NCI HealthyYouTXT--Get Active (HYT--GA)Participants who view the Common Sense Model (CSM) "Be Well" text and image communication will be invited to receive two sets of daily text messages: (1) one text message and one image per day and (2) National Cancer Institute (NCI) HealthyYouTXT-Get Active (HYT-GA) program that is delivered 2-5 times daily for 6 weeks. After baseline and at timepoint 2, participants will view a slide presentation with imagery and text related to colorectal cancer risk and sedentary lifestyle. The same messages will be delivered as a drip campaign alongside the NCI HYT-GA text messaging program. |
| NCI HYT--GA + ACS usual messages | Other | Behavioral: ACS usual messages, Behavioral: NCI HealthyYouTXT--Get Active (HYT--GA)Adapted American Cancer Society (ACS) informational messages about colorectal cancer risk and lifestyle will be invited to receive one set of daily text messages, NCI HealthyYouTXT-Get Active (HYT-GA) program that is delivered 2-5 times daily for 6 weeks. After baseline and at timepoint 2, participants will view an informational slide presentation that is based on adapted language from American Cancer Guidelines related to cancer prevention and physical activity (https://www.cancer.org/healthy/eat-healthy-get-active/acs-guidelines-nutrition-physical-activity-cancer-prevention.html). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
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 |
|---|---|---|
| Common-Sense Model (CSM) Be WellTheoretically informed text messages and images that cover how physical activity is linked to decreasing colorectal cancer risk. | Behavioural | NCI HYT--GA + CSM--Be Well |
| ACS usual messagesInformation distributed by the American Cancer Society as information on the link between physical activity and cancer risk (source: www.cancer.org) | Behavioural | NCI HYT--GA + ACS usual messages |
| NCI HealthyYouTXT--Get Active (HYT--GA)Text messaging program developed by National Cancer Society (NCI). It is a free SMS program that promotes physical activity. | Behavioural | NCI HYT--GA + ACS usual messages, NCI HYT--GA + CSM--Be Well |
Primary outcome
Change in physical active level
Time frame: 6 weeks
Change from physically active levels in METs at 6 weeks
1 secondary outcome
Change in colorectal cancer risk and physical activity coherence
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- BackgroundBuhi, E. R., Trudnak, T. E., Martinasek, M. P., Oberne, A. B., Fuhrmann, H. J., & McDermott, R. J. (2013). Mobile phone-based behavioural interventions for health: A systematic review. Health Education Journal, 72, 564-583.
- Background: PubMed 18302809Cameron LD, Jago L. Emotion regulation interventions: a common-sense model approach. Br J Health Psychol. 2008 May;13(Pt 2):215-21. doi: 10.1348/135910708X288800. Epub 2008 Feb 26.
- BackgroundDurazo, A., & Cameron, L. D. (Manuscript in preparation). A review of cancer risk representations and affect: cancer beliefs and worry as predictors of protection motivation and behavior. Psychological Sciences. University of California, Merced.
- American Cancer Society general information on cancer preventionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Common-Sense Model (CSM) Be Well, ACS usual messages and NCI HealthyYouTXT--Get Active (HYT--GA) in people with Colorectal Cancer and Sedentary Lifestyle, run by University of California, Merced at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 3 Nov 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in physical active level (time frame: 6 weeks). 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 NCT03575117, which also lists 3 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 3 Nov 2022.