Educational Program in Skin Self-Examination To Detect Melanoma in Healthy Participants
Primary Purpose
Melanoma (Skin), Weight Changes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
educational intervention
Sponsored by
About this trial
This is an interventional prevention trial for Melanoma (Skin) focused on measuring melanoma, weight changes
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00416988
First Posted
December 27, 2006
Last Updated
June 19, 2013
Sponsor
Rhode Island Hospital
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00416988
Brief Title
Educational Program in Skin Self-Examination To Detect Melanoma in Healthy Participants
Official Title
Skin Self-Examination for Early Detection of Melanoma: Intervention and Consequence
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rhode Island Hospital
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin), Weight Changes
Keywords
melanoma, weight changes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
1135 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
educational intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin A. Weinstock, MD, PhD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
18406492
Citation
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.
Results Reference
result
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Educational Program in Skin Self-Examination To Detect Melanoma in Healthy Participants
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