Melanoma (Skin)Phase 1/2NCT00403377
Investigation of a Behavioral Substitute for Sunbathing
A Phase 1/2 study testing Intervention in people with Melanoma (Skin) and Skin Cancer, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
RATIONALE: Understanding why sunbathers use or don't use sunless tanning products may help doctors plan effective ways to prevent skin cancer caused by sunbathing. PURPOSE: This phase I/II trial is studying attitudes about the use of sunless tanning products and how well sunless tanning products work as a substitute… Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Melanoma (Skin), Skin Cancer
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Dec 2007
- Phase
- Phase 1/2
- 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 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Self-described sun bather (phase I)
- Intentional sun exposure lasting ≥ 1 hour to get a tan (outside or via tanning salon) at least twice a month during the months of June to August of the prior year
- Intends to continue tanning during the coming summer months
- Random beach-goer (phase II)
PATIENT CHARACTERISTICS:
- Female
- Must speak English
- Must be able to read at the 6th grade level
- No prior sunless tanning products (phase I)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
RATIONALE: Understanding why sunbathers use or don't use sunless tanning products may help doctors plan effective ways to prevent skin cancer caused by sunbathing.
PURPOSE: This phase I/II trial is studying attitudes about the use of sunless tanning products and how well sunless tanning products work as a substitute for sunbathing in healthy participants.
Read the detailed description
OBJECTIVES:
Primary
- Determine participants' attitudes regarding the benefits and barriers to using sunless tanning products after having sampled them. (Phase I)
- Determine participants' opinions, suggestions, and preferences regarding use of sunless tanning products. (Phase I)
- Determine the validity and reliability of the Sunless Tanning Attitudes Survey.
- Determine time spent sunbathing in random beach-goers. (Phase II)
Secondary
- Determine sunburn frequency in random beach-goers. (Phase II)
- Determine the use of a sunless tanner in these participants. (Phase II)
- Determine sun protection use in these participants. (Phase II)
- Determine perceptions of sun protection, susceptibility to photoaging, benefits of sunbathing, and severity of photoaging. (Phase II)
OUTLINE: This is an open-label phase I study followed by a pilot, randomized, controlled phase II study.
- Phase I (focus group): Participants complete the Sunless Tanning Attitudes (STA) survey, Sun Behavior (SB) survey, and the Decisional Balance for Sun Exposure and Sun Protection Questionnaire. Participants who have used a sunless tanner in the past also complete the Sunless Tanner Users (STU) survey. Participants receive sunless tanning lotion and instructions for its use. Participants are instructed to use the sunless tanner for 2 weeks (≥ 3 applications). Participants then complete the STA, SB, and STU surveys and participate in a focus group.
- Phase II:Participants are stratified by beach location and randomized to 1 of 2 intervention arms.
- Arm I: Participants complete surveys as in phase I. Photographs are taken of the participants and they then receive sunscreen lotion and sunless tanning lotion and instructions and benefits for using both. Participants also receive an educational pamphlet regarding skin cancer.
- Arm II: Participants complete surveys as in phase I. A souvenir photograph is taken of the participants and they then receive product samples that are irrelevant to skin cancer risk reduction (e.g., skin moisturizer, hair gel, chewing gum). Participants also receive educational materials at the completion of the study.
In both arms, participants complete surveys again at 2 and 12 months.
PROJECTED ACCRUAL: A total of 330 participants will be accrued for this study.
- Conditions
- Melanoma (Skin), Skin Cancer
- Being tested
- Intervention
- Keywords
- melanoma, basal cell carcinoma of the skin, squamous cell carcinoma of the skin
- Medical subject headings
- Melanoma, Skin Neoplasms, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
In the intervention arm, photographs are taken of the participants and they then receive sunscreen lotion and sunless tanning lotion and instructions and benefits for using both. Participants also receive an educational pamphlet regarding skin cancer.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Phase II include two arms. In the intervention arm, photographs are taken of the participants and they then receive sunscreen lotion and sunless tanning lotion and instructions and benefits for using both. Participants also receive an educational pamphlet regarding skin cancer. Receives: Behavioral: Intervention |
| Control | No intervention | Phase II include two arms. In the control arm, a souvenir photograph is taken of the participants and they then receive product samples that are irrelevant to skin cancer risk reduction (e.g., skin moisturizer, hair gel, chewing gum). Participants also receive educational materials at the completion of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 PO: Attitudes regarding the benefits and barriers to using sunless tanning products after having sampled them
The goal of the initial developmental phase of the present study is to determine the acceptability of sunless tanning as a substitute for sunbathing. Using focus groups comprised of sunbathers given the opportunity to sample sunless tanning products, we will identify perceived barriers and benefits of sunless tanning products, develop motivational messages encouraging the use of sunless tanning products, and preview intervention materials.
Measured: Baseline and Focus Group
Phase II PO: Effectiveness of a beach-based pilot intervention (sun exposure at 2-, and 12- months follow-up)
The intervention will include sun damage imaging, sun safety and sunless tanning education/instruction, and the provision of samples of both sunscreen and sunless tanning products. Feasibility of the intervention, measures, and follow-up procedures will be assessed. The primary outcome for effectiveness will be sun exposure at 2-, and 12- months follow-up and a questionnaire only control group will be employed for comparison.
Measured: Baseline, 2-, and 12-months
Secondary outcomes (2)
Phase 1 SO: The second goal of the initial developmental phase will be to develop psychometrically sound measures of sunless tanner attitudes
To achieve this aim, psychometric analyses including inter-item analyses, autocorrelations, internal consistency, convergent and divergent validity will be conducted, and survey items will be added/revised (if necessary) based on content of focus group discussions.
Measured: Baseline and Focus Group
Phase II SO: Sunburn frequency in random beach goers at 2 and 12 months
The intervention will include sun damage imaging, sun safety and sunless tanning education/instruction, and the provision of samples of both sunscreen and sunless tanning products. Feasibility of the intervention, measures, and follow-up procedures will be assessed. Secondary outcomes will include frequency of sunburns, use of sunless tanning products, sun protection behavior, and perceived benefits/barriers to sunbathing/sun protection.
Measured: Baseline, 2-, and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies 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 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sherry L. Pagoto, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403377
- Sponsor's protocol ID
- CDR0000499830
- Other IDs
- R21CA109670, UMASS-MCC-H-12102, UMASS-MCC-H-11924
- Status last verified
- Sep 2015
- First submitted
- 21 Nov 2006
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pagoto SL, Schneider KL, Oleski J, Bodenlos JS, Merriam P, Ma Y. Design and methods for a cluster randomized trial of the Sunless Study: a skin cancer prevention intervention promoting sunless tanning among beach visitors. BMC Public Health. 2009 Feb 5;9:50. doi: 10.1186/1471-2458-9-50.
PubMed 19196482Pagoto SL, Schneider KL, Oleski J, Bodenlos JS, Ma Y. The sunless study: a beach randomized trial of a skin cancer prevention intervention promoting sunless tanning. Arch Dermatol. 2010 Sep;146(9):979-84. doi: 10.1001/archdermatol.2010.203.
PubMed 20855696
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a Behavioral Substitute for Sunbathing
- ClinicalTrials.gov ID
- NCT00403377
- Acronym / sponsor ID
- CDR0000499830
- Conditions
- Melanoma (Skin), Skin Cancer
- Keywords
- melanoma, basal cell carcinoma of the skin, squamous cell carcinoma of the skin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 23 Nov 2006 (estimated)
- 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.
RATIONALE: Understanding why sunbathers use or don't use sunless tanning products may help doctors plan effective ways to prevent skin cancer caused by sunbathing.
PURPOSE: This phase I/II trial is studying attitudes about the use of sunless tanning products and how well sunless tanning products work as a substitute for sunbathing in healthy participants.
Detailed description
OBJECTIVES:
Primary
- Determine participants' attitudes regarding the benefits and barriers to using sunless tanning products after having sampled them. (Phase I)
- Determine participants' opinions, suggestions, and preferences regarding use of sunless tanning products. (Phase I)
- Determine the validity and reliability of the Sunless Tanning Attitudes Survey.
- Determine time spent sunbathing in random beach-goers. (Phase II)
Secondary
- Determine sunburn frequency in random beach-goers. (Phase II)
- Determine the use of a sunless tanner in these participants. (Phase II)
- Determine sun protection use in these participants. (Phase II)
- Determine perceptions of sun protection, susceptibility to photoaging, benefits of sunbathing, and severity of photoaging. (Phase II)
OUTLINE: This is an open-label phase I study followed by a pilot, randomized, controlled phase II study.
- Phase I (focus group): Participants complete the Sunless Tanning Attitudes (STA) survey, Sun Behavior (SB) survey, and the Decisional Balance for Sun Exposure and Sun Protection Questionnaire. Participants who have used a sunless tanner in the past also complete the Sunless Tanner Users (STU) survey. Participants receive sunless tanning lotion and instructions for its use. Participants are instructed to use the sunless tanner for 2 weeks (≥ 3 applications). Participants then complete the STA, SB, and STU surveys and participate in a focus group.
- Phase II:Participants are stratified by beach location and randomized to 1 of 2 intervention arms.
- Arm I: Participants complete surveys as in phase I. Photographs are taken of the participants and they then receive sunscreen lotion and sunless tanning lotion and instructions and benefits for using both. Participants also receive an educational pamphlet regarding skin cancer.
- Arm II: Participants complete surveys as in phase I. A souvenir photograph is taken of the participants and they then receive product samples that are irrelevant to skin cancer risk reduction (e.g., skin moisturizer, hair gel, chewing gum). Participants also receive educational materials at the completion of the study.
In both arms, participants complete surveys again at 2 and 12 months.
PROJECTED ACCRUAL: A total of 330 participants will be accrued for this study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionPhase II include two arms. In the intervention arm, photographs are taken of the participants and they then receive sunscreen lotion and sunless tanning lotion and instructions and benefits for using both. Participants also receive an educational pamphlet regarding skin cancer. |
| Control | No intervention | –Phase II include two arms. In the control arm, a souvenir photograph is taken of the participants and they then receive product samples that are irrelevant to skin cancer risk reduction (e.g., skin moisturizer, hair gel, chewing gum). Participants also receive educational materials at the completion of the study. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| InterventionIn the intervention arm, photographs are taken of the participants and they then receive sunscreen lotion and sunless tanning lotion and instructions and benefits for using both. Participants also receive an educational pamphlet regarding skin cancer. | Behavioural | Intervention |
Primary outcome
Phase 1 PO: Attitudes regarding the benefits and barriers to using sunless tanning products after having sampled them
Time frame: Baseline and Focus Group
The goal of the initial developmental phase of the present study is to determine the acceptability of sunless tanning as a substitute for sunbathing. Using focus groups comprised of sunbathers given the opportunity to sample sunless tanning products, we will identify perceived barriers and benefits of sunless tanning products, develop motivational messages encouraging the use of sunless tanning products, and preview intervention materials.
Phase II PO: Effectiveness of a beach-based pilot intervention (sun exposure at 2-, and 12- months follow-up)
Time frame: Baseline, 2-, and 12-months
The intervention will include sun damage imaging, sun safety and sunless tanning education/instruction, and the provision of samples of both sunscreen and sunless tanning products. Feasibility of the intervention, measures, and follow-up procedures will be assessed. The primary outcome for effectiveness will be sun exposure at 2-, and 12- months follow-up and a questionnaire only control group will be employed for comparison.
2 secondary outcomes
Phase 1 SO: The second goal of the initial developmental phase will be to develop psychometrically sound measures of sunless tanner attitudes
Time frame: Baseline and Focus Group
Phase II SO: Sunburn frequency in random beach goers at 2 and 12 months
Time frame: Baseline, 2-, and 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 1 Oct 2015.
- Results publication: PubMed 19196482Pagoto SL, Schneider KL, Oleski J, Bodenlos JS, Merriam P, Ma Y. Design and methods for a cluster randomized trial of the Sunless Study: a skin cancer prevention intervention promoting sunless tanning among beach visitors. BMC Public Health. 2009 Feb 5;9:50. doi: 10.1186/1471-2458-9-50.
- Derived from this study: PubMed 20855696Pagoto SL, Schneider KL, Oleski J, Bodenlos JS, Ma Y. The sunless study: a beach randomized trial of a skin cancer prevention intervention promoting sunless tanning. Arch Dermatol. 2010 Sep;146(9):979-84. doi: 10.1001/archdermatol.2010.203.
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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.
Sherry L. Pagoto, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intervention in people with Melanoma (Skin) and Skin Cancer, run by University of Massachusetts, Worcester 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?
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 Oct 2015. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Phase 1 PO: Attitudes regarding the benefits and barriers to using sunless tanning products after having sampled them (time frame: Baseline and Focus Group). 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 NCT00403377, which also lists 2 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 1 Oct 2015.