Skin Cancer PreventionPhase 3NCT04549675
Couple-focused Intervention for Sun Protection
A Phase 3 study testing Sun Safe Partners Online and Generic Online Sun Safety Information intervention in people with Skin Cancer Prevention, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The goal of this pilot study is to develop and test a couple-based intervention to increase sun protection practices. First, the investigators will develop the intervention website, Sun Safe Partners online. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer Prevention
- What is being tested?
- Sun Safe Partners Online and Generic Online Sun Safety Information intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 30 Nov 2020
- Phase
- Phase 3
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both partners age 18-75 years or 19-75 in Nebraska and Alabama given the age of majority in those states;
- Married or co-habiting with a significant other for at least one year;
- Partner 1 willing to to provide contact information for their spouse;
- Partner 1 and spouse respond with never, rarely, sometimes, or often to question " When outdoors in warm weather, how often do participants protect their skin (by staying in the shade or covering your body with protective clothes or 30+ SPF sunscreen)?" Those who respond with always to this question will be excluded.
- Partner 1 and spouse have an email account and internet access.
Who cannot join
- Partner 1 and spouse/partner have a personal history of skin cancer (non-melanoma or melanoma)
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
About this study
Official title: Sun Safe Partners Online: Pilot Randomized Controlled Clinical Trial
The goal of this pilot study is to develop and test a couple-based intervention to increase sun protection practices. First, the investigators will develop the intervention website, Sun Safe Partners online. Next, the investigators will gather feedback and preferences for content in a small sample of couples who do not regularly engage in sun protection practices. The investigators will also gather preliminary information regarding the impact of the couple-based intervention.
Read the detailed description
Aim 1: To develop and evaluate the feasibility of a couple-based sun protection intervention.
Aim 2: To examine the impact of the couple-based sun protection intervention on sun protection practices, individual attitudes, relationship perspective on sun protection, and couples' discussion with each other and their supportive communications about sun protection.
Aim 3: To develop and refine a SunSafe Partners online intervention. This process includes refining existing intervention content drawn from the first phase of this pilot research as well as formative and usability studies to obtain user-generated feedback on additional content and the approach.
Aim 4: To gather pilot data on participation in and evaluations of the Sun Safe partner's intervention from Aim 3.
Arm 1: Web-based intervention called Sun Safe Partners Online
Arm 2: Generic Online Sun Safety Information intervention- 4 links emailed to participants
- Conditions
- Skin Cancer Prevention
- Being tested
- Sun Safe Partners Online, Generic Online Sun Safety Information intervention
- Keywords
- Skin Cancer
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sun Safe Partners OnlineBehavioural
Sun Safe Partners Online has 4 individual-focused modules and 4 couple-focused modules focusing on skin cancer prevention education and sun protection.
Generic Online Sun Safety Information interventionBehavioural
4 links to sent to participants from (1) The Skin Cancer Foundation's Skin Cancer Prevention guidelines, (2) the Centers for Disease Control and Prevention's information on risk factors for skin cancer, (3) the American Academy of Dermatology's information on how to select an appropriate sunscreen, and (4) The Skin Cancer Foundation's information on sun protective clothing. Participants were emailed a link to one of the resources each week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Sun Safe Partners Online Intervention | Experimental | Web-based intervention called Sun Safe Partners Online. Website developed by the study team. Participants received individual username and password to login. Receives: Behavioral: Sun Safe Partners Online |
| Generic Online Sun Safety Information intervention | Active comparator | Publicly online available skin cancer and sun protection information emailed to participants in 4 seperate email links. Receives: Behavioral: Generic Online Sun Safety Information intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sun Protection Behaviors
Impact of Sun Safe Partners Online vs Generic Online intervention on Sun protection behavior measures. The Sun Habits survey asked participants to rate their frequency of 5 sun protection behaviors (sunscreen, hat, shirt with sleeves, long pants, and sunglasses) on warm sunny days (1=never to 5=always).
Measured: Baseline to 1 month FU survey
Sun Exposure
Sun Exposure: The Sun Habits Survey asked participants to rate the duration of outdoor time during peak hours on weekends and weekdays over the past summer months, 1=30 min or less, and 8=more than 6 hours. Self-report measures of time outdoors have s
Measured: Baseline to 1 month FU survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 May 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin Cancer PreventionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Manne, PhD, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549675
- Sponsor's protocol ID
- Pro20150001694
- Other IDs
- 131503
- Status last verified
- Apr 2021
- First submitted
- 8 Sep 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Manne S, Buller D, Devine K, Heckman C, Pagoto S, Frederick S, Mitarotondo A. Sun Safe Partners Online: Pilot Randomized Controlled Clinical Trial. J Med Internet Res. 2020 Sep 17;22(9):e18037. doi: 10.2196/18037.
PubMed 32673215
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sun Safe Partners Online: Pilot Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04549675
- Acronym / sponsor ID
- Pro20150001694
- Conditions
- Skin Cancer Prevention
- Keywords
- Skin Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 16 Sep 2020 (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.
The goal of this pilot study is to develop and test a couple-based intervention to increase sun protection practices. First, the investigators will develop the intervention website, Sun Safe Partners online. Next, the investigators will gather feedback and preferences for content in a small sample of couples who do not regularly engage in sun protection practices. The investigators will also gather preliminary information regarding the impact of the couple-based intervention.
Detailed description
Aim 1: To develop and evaluate the feasibility of a couple-based sun protection intervention.
Aim 2: To examine the impact of the couple-based sun protection intervention on sun protection practices, individual attitudes, relationship perspective on sun protection, and couples' discussion with each other and their supportive communications about sun protection.
Aim 3: To develop and refine a SunSafe Partners online intervention. This process includes refining existing intervention content drawn from the first phase of this pilot research as well as formative and usability studies to obtain user-generated feedback on additional content and the approach.
Aim 4: To gather pilot data on participation in and evaluations of the Sun Safe partner's intervention from Aim 3.
Arm 1: Web-based intervention called Sun Safe Partners Online
Arm 2: Generic Online Sun Safety Information intervention- 4 links emailed to participants
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Sun Safe Partners Online Intervention | Experimental | Behavioral: Sun Safe Partners OnlineWeb-based intervention called Sun Safe Partners Online. Website developed by the study team. Participants received individual username and password to login. |
| Generic Online Sun Safety Information intervention | Active comparator | Behavioral: Generic Online Sun Safety Information interventionPublicly online available skin cancer and sun protection information emailed to participants in 4 seperate email links. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both partners age 18-75 years or 19-75 in Nebraska and Alabama given the age of majority in those states;
- Married or co-habiting with a significant other for at least one year;
- Partner 1 willing to to provide contact information for their spouse;
- Partner 1 and spouse respond with never, rarely, sometimes, or often to question " When outdoors in warm weather, how often do participants protect their skin (by staying in the shade or covering your body with protective clothes or 30+ SPF sunscreen)?" Those who respond with always to this question will be excluded.
- Partner 1 and spouse have an email account and internet access.
Key exclusion criteria (2 listed)
- Partner 1 and spouse/partner have a personal history of skin cancer (non-melanoma or melanoma)
- -
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 |
|---|---|---|
| Sun Safe Partners OnlineSun Safe Partners Online has 4 individual-focused modules and 4 couple-focused modules focusing on skin cancer prevention education and sun protection. | Behavioural | Arm 1 Sun Safe Partners Online Intervention |
| Generic Online Sun Safety Information intervention4 links to sent to participants from (1) The Skin Cancer Foundation's Skin Cancer Prevention guidelines, (2) the Centers for Disease Control and Prevention's information on risk factors for skin cancer, (3) the American Academy of Dermatology's information on how to select an appropriate sunscreen, and (4) The Skin Cancer Foundation's information on sun protective clothing. Participants were emailed a link to one of the resources each week for 4 weeks. | Behavioural | Generic Online Sun Safety Information intervention |
Primary outcome
Sun Protection Behaviors
Time frame: Baseline to 1 month FU survey
Impact of Sun Safe Partners Online vs Generic Online intervention on Sun protection behavior measures. The Sun Habits survey asked participants to rate their frequency of 5 sun protection behaviors (sunscreen, hat, shirt with sleeves, long pants, and sunglasses) on warm sunny days (1=never to 5=always).
Sun Exposure
Time frame: Baseline to 1 month FU survey
Sun Exposure: The Sun Habits Survey asked participants to rate the duration of outdoor time during peak hours on weekends and weekdays over the past summer months, 1=30 min or less, and 8=more than 6 hours. Self-report measures of time outdoors have s
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 8 Apr 2021.
- Derived from this study: PubMed 32673215Manne S, Buller D, Devine K, Heckman C, Pagoto S, Frederick S, Mitarotondo A. Sun Safe Partners Online: Pilot Randomized Controlled Clinical Trial. J Med Internet Res. 2020 Sep 17;22(9):e18037. doi: 10.2196/18037.
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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 Phase 3 study testing Sun Safe Partners Online and Generic Online Sun Safety Information intervention in people with Skin Cancer Prevention, run by Rutgers, The State University of New Jersey 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 2 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 8 Apr 2021. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Sun Protection Behaviors (time frame: Baseline to 1 month FU survey). The study lists 2 primary outcomes in all. 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 NCT04549675, which also lists 1 linked publication.
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 8 Apr 2021.