N/A
N=130
Partner Assistance in Learning and Performing Skin Self-Examination
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01013844 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Mean Number of Skin Examinations Without Partner Over 4 Months — 0.02; 0.00; 0.02; 0.00 Times examined skin by self
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Skin Self Examination Information and ABCDE Rule (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of Skin Examinations Without Partner Over 4 Months |
0.02; 0.00; 0.02; 0.00; 0.23; 0.80 | — |
| PRIMARY Mean Number of Skin Examinations With Partner Over 4 Months |
0.0; 0.0; 0.0; 0.0; 0.23; 0.81 | — |
| PRIMARY Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months |
.03; 0.0; 0.08; 0.0; 0.55; 0.91 | — |
Summary
This study is a behavioral science study designed to identify aspects of the dyadic relationship that promote Skin Self-Examination (SSE) in patients at high risk of developing melanoma. The patient is randomized to receive the educational intervention either as a solo learner or with the partner.
Eligibility Criteria
Inclusion Criteria
- Personal or family history of melanoma. If a personal history of melanoma, the patient was treated at least 1 month ago
- Evidence of dysplastic nevus syndrome or a large number of moles (Greater than 50)
- Able to see to read a newspaper, can read at an eighth grade level
- Speaks English
- 18 to 70 years old with a spouse or cohabitating partner
Exclusion Criteria
- Under 18 years of age
- Patient overburden by other co-morbid diseases such as chronic immunosuppression from organ transplantation
- Have insufficient vision to to read a newspaper
- Unable to read English
- Have insufficient cognitive skills to follow instructions provided at an eighth grade language level
Data sourced from ClinicalTrials.gov (NCT01013844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.