NCT00416988CompletedNot Applicable
Skin Self-Examination for Early Detection of Melanoma: Intervention and Consequence
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rhode Island Hospital
- Enrollment
- 1,135
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Prevention
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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
Exclusion Criteria
- Not provided
Investigators
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