Environmental Exposure to Ultraviolet LightNCT03340532
HealthSmart: Promoting Healthy Lifestyles for Young Adult Cancer Survivors Using Educational Videos
A study testing THE INFORMATION + APPEARANCE VIDEO, Information SunSmart video and Sleep hygiene video in people with Environmental Exposure to Ultraviolet Light, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
To assess the efficacy of the two SunSmart intervention videos to change sun protection attitudes and behaviors Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Environmental Exposure to Ultraviolet Light
- What is being tested?
- THE INFORMATION + APPEARANCE VIDEO, Information SunSmart video and Sleep hygiene video
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2018to 27 Sep 2021
- 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
- No healthy volunteers
- Adult
Who may be able to join
- History of cancer diagnosis at least one year prior
- Current age 18-35
- No cancer therapy in the prior 3 months (excluding chemoprevention agents)
- No future cancer therapy planned
- Able to read and write in English
- Not compliant with recommended sun protection, as determined by at least one of the following criteria:
- Any intentional sunbathing, artificial tanning or a sunburn in the past 5 years; OR
- Having a moderate to light complexion (Fitzpatrick skin types I-IV), and not using sunscreen ≥ 90% of the time during incidental sun exposure.
Who cannot join
- History of skin cancer diagnosis
- Enrolled on DFCI protocol 17-385 or any other sun protection intervention in the past 5 years.
- Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all measures independently
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
To assess the efficacy of the two SunSmart intervention videos to change sun protection attitudes and behaviors
Read the detailed description
SunSmart is a novel video intervention designed to prevent secondary skin cancer in young adult cancer survivors by increasing their adherence to recommended sun protection.
This study will assess two versions of the SunSmart video intervention. These are: 1) The INFORMATION VIDEO providing basic information about UV risks, including secondary skin cancer and the benefits of sun protection (SP), as well as specific SP recommendations and steps to integrate SP as part of routine self-care for the healthy cancer survivor; and 2) THE INFORMATION + APPEARANCE VIDEO which will include the full information video, along with an additional embedded video segment emphasizing negative appearance consequences of UV exposure. Primary aim of the study is to assess the impact of the video intervention on sun protection intentions and behavior in young adult cancer survivors compared to a control intervention. Secondary aims are to describe the impact of the appearance information when included in the SunSmart intervention, to investigate the extent to which the intervention changes sun protection through hypothesized mediating variables, and to describe the consistency of sleep behaviors over time in cancer survivors.
- Being tested
- THE INFORMATION + APPEARANCE VIDEO, Information SunSmart video, Sleep hygiene video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THE INFORMATION + APPEARANCE VIDEOOther
THE INFORMATION + APPEARANCE VIDEO which will include the full information video, along with an additional embedded video segment emphasizing negative appearance consequences of UV exposure.
Information SunSmart videoOther
The INFORMATION SunSmart video providing basic information about UV risks, including secondary skin cancer and the benefits of SP, as well as specific SP recommendations and steps to integrate SP as part of routine self-care for the healthy cancer survivor
Sleep hygiene videoOther
Contain information on better sleep hygiene
| Study group | Role | What they receive |
|---|---|---|
| Sleep hygiene video | Placebo comparator | Participants will watch a sleep hygiene video Receives: Other: Sleep hygiene video |
| Information video | Experimental | The INFORMATION SunSmart video providing basic information about UV risks, including secondary skin cancer and the benefits of SP, as well as specific SP recommendations and steps to integrate SP as part of routine self-care for the healthy cancer survivor Receives: Other: Information SunSmart video |
| Information + Appearance video | Experimental | THE INFORMATION + APPEARANCE VIDEO which will include the full information video, along with an additional embedded video segment emphasizing negative appearance consequences of UV exposure. Receives: Other: THE INFORMATION + APPEARANCE VIDEO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SP Index scores from baseline to post-summer assessment
SP index is comprised of 15 self-report items assessing SP Behaviors
Measured: 3 months
Secondary outcomes (6)
Perceived appearance vulnerability
2 items assessing perceived likelihood that UV exposure will lead to negative appearance changes
Measured: one month
Perceived health and appearance benefit
8 self-report items assessing expected benefits to SP
Measured: one month
Perceived health vulnerability
2 items assessing perceived likelihood that UV exposure will lead to future skin cancers.
Measured: one month
SP Intentions
13 items measuring intentions to practice SP
Measured: one month
Insomnia symptoms
7 -item Insomnia Severity Scale (ISS). Total ISS scale scores range from a low of 0 (least insomnia) to a high of 28 (worst insomnia)
Measured: one month
Change in SP Index scores from post-summer assessment to one year later
SP index is comprised of 15 self-report items assessing SP Behaviors
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start30 Jan 2018
- Primary completion28 Sep 2020
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental Exposure to Ultraviolet LightStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to view one of two SunSmart educational videos or a control video on sleep hygiene. In the three months following the video intervention, participants' sun protection attitudes and behaviors are assessed. An additional measure of sun protection behaviors 12-months later will be provided by participants who participate in the optional 1-year follow-up.
- Masking
- None (open label)
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Prevent Cancer Foundation
- Responsible party
- Principal investigator, Christopher Recklitis, Ph.D, Dana-Farber Cancer Institute
- Investigators
- Christopher Recklitis, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340532
- Sponsor's protocol ID
- 17-515
- Other IDs
- R03CA230818-02
- Status last verified
- May 2022
- First submitted
- 9 Nov 2017
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HealthSmart: Promoting Healthy Lifestyles for Young Adult Cancer Survivors Using Educational Videos
- ClinicalTrials.gov ID
- NCT03340532
- Acronym / sponsor ID
- 17-515
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Prevent Cancer Foundation
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 13 Nov 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.
To assess the efficacy of the two SunSmart intervention videos to change sun protection attitudes and behaviors
Detailed description
SunSmart is a novel video intervention designed to prevent secondary skin cancer in young adult cancer survivors by increasing their adherence to recommended sun protection.
This study will assess two versions of the SunSmart video intervention. These are: 1) The INFORMATION VIDEO providing basic information about UV risks, including secondary skin cancer and the benefits of sun protection (SP), as well as specific SP recommendations and steps to integrate SP as part of routine self-care for the healthy cancer survivor; and 2) THE INFORMATION + APPEARANCE VIDEO which will include the full information video, along with an additional embedded video segment emphasizing negative appearance consequences of UV exposure. Primary aim of the study is to assess the impact of the video intervention on sun protection intentions and behavior in young adult cancer survivors compared to a control intervention. Secondary aims are to describe the impact of the appearance information when included in the SunSmart intervention, to investigate the extent to which the intervention changes sun protection through hypothesized mediating variables, and to describe the consistency of sleep behaviors over time in cancer survivors.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are randomized to view one of two SunSmart educational videos or a control video on sleep hygiene. In the three months following the video intervention, participants' sun protection attitudes and behaviors are assessed. An additional measure of sun protection behaviors 12-months later will be provided by participants who participate in the optional 1-year follow-up.
| Arm | Type | Receives |
|---|---|---|
| Sleep hygiene video | Placebo comparator | Other: Sleep hygiene videoParticipants will watch a sleep hygiene video |
| Information video | Experimental | Other: Information SunSmart videoThe INFORMATION SunSmart video providing basic information about UV risks, including secondary skin cancer and the benefits of SP, as well as specific SP recommendations and steps to integrate SP as part of routine self-care for the healthy cancer survivor |
| Information + Appearance video | Experimental | Other: THE INFORMATION + APPEARANCE VIDEOTHE INFORMATION + APPEARANCE VIDEO which will include the full information video, along with an additional embedded video segment emphasizing negative appearance consequences of UV exposure. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- History of cancer diagnosis at least one year prior
- Current age 18-35
- No cancer therapy in the prior 3 months (excluding chemoprevention agents)
- No future cancer therapy planned
- Able to read and write in English
Key exclusion criteria (3 listed)
- History of skin cancer diagnosis
- Enrolled on DFCI protocol 17-385 or any other sun protection intervention in the past 5 years.
- Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all measures independently
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 |
|---|---|---|
| THE INFORMATION + APPEARANCE VIDEOTHE INFORMATION + APPEARANCE VIDEO which will include the full information video, along with an additional embedded video segment emphasizing negative appearance consequences of UV exposure. | Other | Information + Appearance video |
| Information SunSmart videoThe INFORMATION SunSmart video providing basic information about UV risks, including secondary skin cancer and the benefits of SP, as well as specific SP recommendations and steps to integrate SP as part of routine self-care for the healthy cancer survivor | Other | Information video |
| Sleep hygiene videoContain information on better sleep hygiene | Other | Sleep hygiene video |
Primary outcome
Change in SP Index scores from baseline to post-summer assessment
Time frame: 3 months
SP index is comprised of 15 self-report items assessing SP Behaviors
6 secondary outcomes
Perceived appearance vulnerability
Time frame: one month
Perceived health and appearance benefit
Time frame: one month
Perceived health vulnerability
Time frame: one month
SP Intentions
Time frame: one month
Insomnia symptoms
Time frame: one month
Change in SP Index scores from post-summer assessment to one year later
Time frame: 12-months
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 6 May 2022.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
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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.
Christopher Recklitis, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THE INFORMATION + APPEARANCE VIDEO, Information SunSmart video and Sleep hygiene video in people with Environmental Exposure to Ultraviolet Light, run by Dana-Farber Cancer Institute 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 8 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 6 May 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. 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 SP Index scores from baseline to post-summer assessment (time frame: 3 months). 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 6 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.