Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416988
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2006-12-27
Brief Title:
Educational Program in Skin Self-Examination To Detect Melanoma in Healthy Participants
Sponsor:
Rhode Island Hospital
Organization:
Rhode Island Hospital
Study Overview
Official Title:
Skin Self-Examination for Early Detection of Melanoma Intervention and Consequence
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 1135 participants will be accrued for this study
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 1135 participants will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RIH-R01-CA78800 | None | None | None |