Melanoma (Skin)NCT00416988
Educational Program in Skin Self-Examination To Detect Melanoma in Healthy Participants
A study testing educational intervention in people with Melanoma (Skin) and Weight Changes, run by Rhode Island Hospital.
Trial summary
RATIONALE: An educational program may be effective in increasing monthly skin self-examinations to detect melanoma in healthy participants. PURPOSE: This randomized clinical trial is studying how well an educational program works in increasing monthly skin self-examinations to detect melanoma in healthy participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma (Skin), Weight Changes
- What is being tested?
- educational intervention
- How many people
- 1,135 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Healthy participants who are scheduled for a routine or health maintenance visit with a participating primary care office that meets all of the following criteria:
- At least 50% of patients are being seen for regular ongoing general medical care
- Specializes in internal medicine (subspecialties allowed), family medicine, or obstetrics/gynecology
- Employs at least 2 physicians who meet all of the following requirements:
- Agree to participate
- Work full-time, defined as at least 8 sessions per week of 3 or more hours
- Completed post-graduate training
- Not a federal employee or full-time hospital-based faculty
- Have been in practice at least 1 year
- Not planning on relocating or retiring within the next 3 years
PATIENT CHARACTERISTICS:
- Must be able to read in either English or Spanish
- Has no household member who has been previously enrolled on this study, including a person who has the same telephone number or address
- Not in acute discomfort
- Able to comply with intervention
- No impairment that would preclude skin self-examination
- Must be able to view video
- No illness or disability that would preclude participation in the study interview
PRIOR CONCURRENT THERAPY:
- Must not have been previously enrolled on this study
About this study
Official title: Skin Self-Examination for Early Detection of Melanoma: Intervention and Consequence
RATIONALE: An educational program may be effective in increasing monthly skin self-examinations to detect melanoma in healthy participants.
PURPOSE: This randomized clinical trial is studying how well an educational program works in increasing monthly skin self-examinations to detect melanoma in healthy participants.
Read the detailed description
OBJECTIVES:
- Determine the incidence of monthly thorough skin self-examinations (TSE) for early detection of melanoma in healthy participants who are under routine care by their primary care physician.
- Determine the impact of the intervention package and the resulting change in TSE performance, in terms of visits to healthcare providers for skin problems, in these participants.
- Evaluate the efficacy of this intervention package in improving performance of TSE in these participants.
- Estimate potential effect of this intervention on health care resource use.
OUTLINE: This is a controlled, randomized study.
Two weeks prior to their appointment with their physician, participants undergo a baseline assessment. During the appointment, participants are randomized to 1 of 2 intervention arms.
- Arm I (control): Participants receive written educational materials and watch a video on healthy dietary habits during their appointment. They receive nutrition tip sheets, including information related to reducing fat, saturated fat, and cholesterol in the diet, at 2 and 6 months after their initial appointment. Participants also undergo telephone assessments at 2, 6, and 12 months after their initial appointment.
- Arm II (skin self-examinations): Participants undergo a 10- to 15-minute face-to-face counseling session with the study intervention specialist and receive training in thorough skin self-examination (TSE) directly after their appointment. They also receive written educational materials and watch a 25-minute video designed to motivate and teach them to do TSE. Two weeks later, participants receive a follow-up call from the same study intervention specialist. Participants receive tailored feedback at 2 and 6 months and a motivational postcard at 4 months after their initial appointment. Participants also undergo telephone assessments as in arm I.
Participating physicians seeing participants in both arms attend a 60-minute educational session regarding skin cancer detection, prevention, identification, and triage, supplemented by written materials. They are also trained and prompted to deliver a 30-second message emphasizing the desirability of performing monthly TSE during their appointment with participants.
After completion of the study intervention, participants are offered the educational materials of the intervention arm to which they were not randomized.
PROJECTED ACCRUAL: A total of 1,135 participants will be accrued for this study.
- Conditions
- Melanoma (Skin), Weight Changes
- Being tested
- educational intervention
- Keywords
- melanoma, weight changes
- Medical subject headings
- Melanoma, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
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 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Enrolment
- 1,135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Martin A. Weinstock, MD, PhD, Study chair, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416988
- Sponsor's protocol ID
- CDR0000454855
- Other IDs
- RIH-R01-CA78800
- Status last verified
- Jul 2008
- First submitted
- 27 Dec 2006
- Last updated
- 20 Jun 2013
- Results posted
- No
Publications
Lee KB, Weinstock MA, Risica PM. Components of a successful intervention for monthly skin self-examination for early detection of melanoma: the "Check It Out" trial. J Am Acad Dermatol. 2008 Jun;58(6):1006-12. doi: 10.1016/j.jaad.2008.03.008. Epub 2008 Apr 11.
PubMed 18406492
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Self-Examination for Early Detection of Melanoma: Intervention and Consequence
- ClinicalTrials.gov ID
- NCT00416988
- Acronym / sponsor ID
- CDR0000454855
- Conditions
- Melanoma (Skin), Weight Changes
- Keywords
- melanoma, weight changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,135 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 28 Dec 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: An educational program may be effective in increasing monthly skin self-examinations to detect melanoma in healthy participants.
PURPOSE: This randomized clinical trial is studying how well an educational program works in increasing monthly skin self-examinations to detect melanoma in healthy participants.
Detailed description
OBJECTIVES:
- Determine the incidence of monthly thorough skin self-examinations (TSE) for early detection of melanoma in healthy participants who are under routine care by their primary care physician.
- Determine the impact of the intervention package and the resulting change in TSE performance, in terms of visits to healthcare providers for skin problems, in these participants.
- Evaluate the efficacy of this intervention package in improving performance of TSE in these participants.
- Estimate potential effect of this intervention on health care resource use.
OUTLINE: This is a controlled, randomized study.
Two weeks prior to their appointment with their physician, participants undergo a baseline assessment. During the appointment, participants are randomized to 1 of 2 intervention arms.
- Arm I (control): Participants receive written educational materials and watch a video on healthy dietary habits during their appointment. They receive nutrition tip sheets, including information related to reducing fat, saturated fat, and cholesterol in the diet, at 2 and 6 months after their initial appointment. Participants also undergo telephone assessments at 2, 6, and 12 months after their initial appointment.
- Arm II (skin self-examinations): Participants undergo a 10- to 15-minute face-to-face counseling session with the study intervention specialist and receive training in thorough skin self-examination (TSE) directly after their appointment. They also receive written educational materials and watch a 25-minute video designed to motivate and teach them to do TSE. Two weeks later, participants receive a follow-up call from the same study intervention specialist. Participants receive tailored feedback at 2 and 6 months and a motivational postcard at 4 months after their initial appointment. Participants also undergo telephone assessments as in arm I.
Participating physicians seeing participants in both arms attend a 60-minute educational session regarding skin cancer detection, prevention, identification, and triage, supplemented by written materials. They are also trained and prompted to deliver a 30-second message emphasizing the desirability of performing monthly TSE during their appointment with participants.
After completion of the study intervention, participants are offered the educational materials of the intervention arm to which they were not randomized.
PROJECTED ACCRUAL: A total of 1,135 participants will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| educational intervention | Other | – |
Primary outcome
Not reported in the source record.
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 20 Jun 2013.
- Results publication: PubMed 18406492Lee KB, Weinstock MA, Risica PM. Components of a successful intervention for monthly skin self-examination for early detection of melanoma: the "Check It Out" trial. J Am Acad Dermatol. 2008 Jun;58(6):1006-12. doi: 10.1016/j.jaad.2008.03.008. Epub 2008 Apr 11.
Related trials for Melanoma (Skin)
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Breast Carcinoma, Colorectal Carcinoma
Enrolling by invitationObservational study
Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
Melanoma, Adenocarcinoma
RecruitingPhase 1
Dose Ranging, Toxicity Seeking, Phase 1 Trial of Oncolytic Adenoviral Therapy for Melanoma Intracranial and Extracranial Metastases
Melanoma
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.
Martin A. Weinstock, MD, PhD study chair
Rhode Island Hospital
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention in people with Melanoma (Skin) and Weight Changes, run by Rhode Island Hospital.
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 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00416988, 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 20 Jun 2013.