June K Robinson1, Jeffrey D Wayne2, Mary C Martini3, Brittney A Hultgren4, Kimberly A Mallett4, Rob Turrisi4. 1. Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois2Editor, JAMA Dermatology. 2. Division of Gastrointestinal & Oncologic Surgery, Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois. 3. Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois. 4. Biobehavioral Health and Prevention Research Center, Penn State, University Park, Pennsylvania.
Abstract
IMPORTANCE: More than 1 million patients with melanoma in the United States are at risk to develop a second primary melanoma. Early detection of melanoma improves survival. Patients with melanoma may be able to self-manage care with their skin-check partners ("partners") and alert the physician when a concerning lesion is identified, thus providing an important adjunct to yearly skin examinations by a physician. OBJECTIVE: To evaluate the effect of a structured skin self-examination (SSE) intervention for patients with melanoma and their partners ("dyads") on SSE performance and the detection of new melanomas by the dyad or the physician. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial with 24-month follow-up assessments. Patients with stage 0 to IIB melanoma and their skin-check partners participated from June 6, 2011, to April 24, 2015. INTERVENTIONS:Dyads of patients and their partners were randomly assigned to receive the skills training intervention or customary care (control group). MAIN OUTCOMES AND MEASURES: The main outcome was frequency of SSE performance. The secondary outcome was detection of a new or recurrent melanoma by the dyad or physician. The tertiary outcome was the number of unscheduled physician appointments for concerning lesions. RESULTS: The study cohort comprised 494 participants. The patient population was 51.2% (253 of 494) female and had a mean (SD) age of 55 (10) years. Patients in the intervention arms had significantly increased SSEs with their partners at 4, 12, and 24 months (P < .001 for all) compared with the control group (mean differences, 1.57 [95% CI, 1.29-1.85], 0.72 [95% CI, 0.39-1.06], and 0.94 [95% CI, 0.58-1.30], respectively). Patients in the intervention arms identified new melanomas more than those in the control group (χ21 = 28.77, P < .01 [n = 51 melanomas in situ] and χ21 = 6.43, P < .05 [n = 18 invasive melanomas]) and did not increase physician visits. CONCLUSIONS AND RELEVANCE: Patients with melanoma and their partners reliably performedSSE after participating in a structured skills training program lasting approximately 30 minutes, with reinforcement every 4 months by the study dermatologist. Accurate SSE by those at risk to develop melanoma may enhance early detection and relieve some of the burden on health services to provide continuing follow-up to a growing population of eligible patients. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01432860.
RCT Entities:
IMPORTANCE: More than 1 million patients with melanoma in the United States are at risk to develop a second primary melanoma. Early detection of melanoma improves survival. Patients with melanoma may be able to self-manage care with their skin-check partners ("partners") and alert the physician when a concerning lesion is identified, thus providing an important adjunct to yearly skin examinations by a physician. OBJECTIVE: To evaluate the effect of a structured skin self-examination (SSE) intervention for patients with melanoma and their partners ("dyads") on SSE performance and the detection of new melanomas by the dyad or the physician. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial with 24-month follow-up assessments. Patients with stage 0 to IIB melanoma and their skin-check partners participated from June 6, 2011, to April 24, 2015. INTERVENTIONS: Dyads of patients and their partners were randomly assigned to receive the skills training intervention or customary care (control group). MAIN OUTCOMES AND MEASURES: The main outcome was frequency of SSE performance. The secondary outcome was detection of a new or recurrent melanoma by the dyad or physician. The tertiary outcome was the number of unscheduled physician appointments for concerning lesions. RESULTS: The study cohort comprised 494 participants. The patient population was 51.2% (253 of 494) female and had a mean (SD) age of 55 (10) years. Patients in the intervention arms had significantly increased SSEs with their partners at 4, 12, and 24 months (P < .001 for all) compared with the control group (mean differences, 1.57 [95% CI, 1.29-1.85], 0.72 [95% CI, 0.39-1.06], and 0.94 [95% CI, 0.58-1.30], respectively). Patients in the intervention arms identified new melanomas more than those in the control group (χ21 = 28.77, P < .01 [n = 51 melanomas in situ] and χ21 = 6.43, P < .05 [n = 18 invasive melanomas]) and did not increase physician visits. CONCLUSIONS AND RELEVANCE: Patients with melanoma and their partners reliably performed SSE after participating in a structured skills training program lasting approximately 30 minutes, with reinforcement every 4 months by the study dermatologist. Accurate SSE by those at risk to develop melanoma may enhance early detection and relieve some of the burden on health services to provide continuing follow-up to a growing population of eligible patients. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01432860.
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