Skin CarcinomaSMARTNCT03177057
SMART Project in Preventing Skin Cancer
A study testing Compliance Monitoring, Health Telemonitoring and Questionnaire Administration in people with Skin Carcinoma, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
This pilot clinical trial studies how well Self Monitoring And Readiness Texting (SMART) project works in sun exposure and protection behaviors. Measuring how behavior tracking and individually tailored messages affect risk behaviors in patients with skin cancer may help doctors plan the best prevention plan and… Read more about this study
- Who is it for?
- Ages 18 to 29 years, women only
- Conditions the study is for
- Skin Carcinoma
- What is being tested?
- Compliance Monitoring, Health Telemonitoring and Questionnaire Administration
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2013to 31 Dec 2014
- 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 29 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women from the Philadelphia metropolitan area who own a mobile phone and who meet criteria for at least moderate risk of skin cancer based on a brief risk assessment tool
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Self-Monitoring and Readiness Texting Project (SMART)
This pilot clinical trial studies how well Self Monitoring And Readiness Texting (SMART) project works in sun exposure and protection behaviors. Measuring how behavior tracking and individually tailored messages affect risk behaviors in patients with skin cancer may help doctors plan the best prevention plan and decrease national melanoma incidence and mortality.
Read the detailed description
PRIMARY OBJECTIVES:
- To test the effects of a behavior tracking and individually-tailored daily text message intervention on sun protection and exposure behaviors and to see if these techniques will be most effective in conjunction or separately.
SECONDARY OBJECTIVES:
- To examine mediators in the effects of the intervention on safe sun behaviors, based on Fishbein?s Integrative Model.
OUTLINE: Patients are randomized to 1 of 4 study arms.
ARM I (SELF-MONITORING): Patients complete tanning and sun protection usage entries daily for 14 days.
ARM II (TEXT MESSAGES): Patients receive individualized text messages based on baseline assessment of tanning motives (appearance, enjoyment, social) daily for 14 days.
ARM III (COMBINED GROUP): Patients complete tanning and sun protection usage entries and also receive individualized text messages daily for 14 days.
ARM IV (CONTROL GROUP): Patients complete study assessments.
After completion of study, patients are followed up at 2 weeks.
- Conditions
- Skin Carcinoma
- Being tested
- Compliance Monitoring, Health Telemonitoring, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compliance MonitoringBehavioural
Record behavior
Health TelemonitoringOther
Receive health monitoring text messages
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (self-monitoring) | Experimental | ARM I (SELF-MONITORING): Patients complete tanning and sun protection usage entries daily for 14 days. Receives: Behavioral: Compliance Monitoring; Other: Questionnaire Administration |
| Arm II (text messages) | Experimental | ARM II (TEXT MESSAGES): Patients receive individualized text messages based on baseline assessment of tanning motives (appearance, enjoyment, social) daily for 14 days. Receives: Other: Health Telemonitoring; Other: Questionnaire Administration |
| Arm III (self-monitoring, text messages) | Experimental | ARM III (COMBINED GROUP): Patients complete tanning and sun protection usage entries and also receive individualized text messages daily for 14 days. Receives: Behavioral: Compliance Monitoring; Other: Health Telemonitoring; Other: Questionnaire Administration |
| Arm IV (questionnaire administration) | Sham comparator | ARM IV (CONTROL GROUP): Patients complete study assessments. Receives: Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ultraviolet radiation (UV) exposure and sun protection behaviors based on behavior tracking and individually tailored daily text messages
Multiple variable regression models will be performed to examine the effect of the intervention on the outcomes. All post-baseline outcomes will be used as dependent variables. The baseline scores, intervention group, and time of the assessment will be included. To account for the within subject correlation of the responses, we will fit the model using Generalized Estimating Equations assuming an autoregressive working correlation matrix for each subject. Any p-value from the pairwise comparison that is less than 0.05 will be considered worthy of further study.
Measured: Baseline to up to 2 weeks
Secondary outcomes (1)
Mediators and moderators of the intervention on behavior
Mediation will be assessed by examining indirect effects, with bootstrapped confidence intervals to be calculated around the mediated effects. For participants who use the self-monitoring app, hierarchical linear modeling will be used to examine associations between tanning and sun protection as they occur daily, and motives for doing so. Using lagged multi-level models, the within-person model allows for assessment of individual change in behavior over the two-week time period, as well as the effect of each day?s behavior on behavior occurring on subsequent days. The between-person model allo
Measured: At 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start23 Apr 2013
- Primary completion30 Jul 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CarcinomaStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Carolyn Heckman, Fox Chase Cancer Center
- Investigators
- Carolyn Heckman, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177057
- Sponsor's protocol ID
- IRB12846
- Other IDs
- NCI-2015-02089, IRB12846, P30CA006927
- Acronym
- SMART
- Status last verified
- Jul 2018
- First submitted
- 2 Jun 2017
- Last updated
- 1 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Monitoring and Readiness Texting Project (SMART)
- ClinicalTrials.gov ID
- NCT03177057
- Acronym / sponsor ID
- SMART / IRB12846
- Conditions
- Skin Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Apr 2013 (actual)
- Primary completion
- 30 Jul 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 6 Jun 2017 (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 pilot clinical trial studies how well Self Monitoring And Readiness Texting (SMART) project works in sun exposure and protection behaviors. Measuring how behavior tracking and individually tailored messages affect risk behaviors in patients with skin cancer may help doctors plan the best prevention plan and decrease national melanoma incidence and mortality.
Detailed description
PRIMARY OBJECTIVES:
- To test the effects of a behavior tracking and individually-tailored daily text message intervention on sun protection and exposure behaviors and to see if these techniques will be most effective in conjunction or separately.
SECONDARY OBJECTIVES:
- To examine mediators in the effects of the intervention on safe sun behaviors, based on Fishbein?s Integrative Model.
OUTLINE: Patients are randomized to 1 of 4 study arms.
ARM I (SELF-MONITORING): Patients complete tanning and sun protection usage entries daily for 14 days.
ARM II (TEXT MESSAGES): Patients receive individualized text messages based on baseline assessment of tanning motives (appearance, enjoyment, social) daily for 14 days.
ARM III (COMBINED GROUP): Patients complete tanning and sun protection usage entries and also receive individualized text messages daily for 14 days.
ARM IV (CONTROL GROUP): Patients complete study assessments.
After completion of study, patients are followed up at 2 weeks.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I (self-monitoring) | Experimental | Behavioral: Compliance Monitoring, Other: Questionnaire AdministrationARM I (SELF-MONITORING): Patients complete tanning and sun protection usage entries daily for 14 days. |
| Arm II (text messages) | Experimental | Other: Health Telemonitoring, Other: Questionnaire AdministrationARM II (TEXT MESSAGES): Patients receive individualized text messages based on baseline assessment of tanning motives (appearance, enjoyment, social) daily for 14 days. |
| Arm III (self-monitoring, text messages) | Experimental | Behavioral: Compliance Monitoring, Other: Health Telemonitoring, Other: Questionnaire AdministrationARM III (COMBINED GROUP): Patients complete tanning and sun protection usage entries and also receive individualized text messages daily for 14 days. |
| Arm IV (questionnaire administration) | Sham comparator | Other: Questionnaire AdministrationARM IV (CONTROL GROUP): Patients complete study assessments. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women from the Philadelphia metropolitan area who own a mobile phone and who meet criteria for at least moderate risk of skin cancer based on a brief risk assessment tool
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Compliance MonitoringRecord behavior | Behavioural | Arm I (self-monitoring), Arm III (self-monitoring, text messages) |
| Health TelemonitoringReceive health monitoring text messages | Other | Arm II (text messages), Arm III (self-monitoring, text messages) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (self-monitoring), Arm II (text messages), Arm III (self-monitoring, text messages), Arm IV (questionnaire administration) |
Primary outcome
Change in ultraviolet radiation (UV) exposure and sun protection behaviors based on behavior tracking and individually tailored daily text messages
Time frame: Baseline to up to 2 weeks
Multiple variable regression models will be performed to examine the effect of the intervention on the outcomes. All post-baseline outcomes will be used as dependent variables. The baseline scores, intervention group, and time of the assessment will be included. To account for the within subject correlation of the responses, we will fit the model using Generalized Estimating Equations assuming an autoregressive working correlation matrix for each subject. Any p-value from the pairwise comparison that is less than 0.05 will be considered worthy of further study.
1 secondary outcome
Mediators and moderators of the intervention on behavior
Time frame: At 2 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 1 Aug 2018.
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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.
Carolyn Heckman principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compliance Monitoring, Health Telemonitoring and Questionnaire Administration in people with Skin Carcinoma, run by Fox Chase Cancer Center 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 1 inclusion and 0 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 1 Aug 2018. 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. Some participants in this study may receive a placebo. 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 ultraviolet radiation (UV) exposure and sun protection behaviors based on behavior tracking and individually tailored daily text messages (time frame: Baseline to up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2018.