Comparison of Efficacy of Differing Partner-Assisted Skin Examination Interventions for Melanoma Patients: A Randomized Clinical Trial

Abstract

Importance: Early detection of melanoma may improve survival. The present study continued research establishing that in-person training on skin self-examinations (SSEs) was significantly enhanced when delivered to patients with their partners present instead of to patients alone.

Objective: To examine 3 alternative SSE training approaches that included partners compared with a treatment-as-usual control condition.

Design, setting, and participants: A randomized clinical trial with 4- and 12-month follow-up visits was conducted at the clinical offices in the ambulatory care area of a hospital. The evaluable population included 494 patients with stage 0 to IIB melanoma and their skin check partners drawn from an electronic medical record melanoma registry and advertisements in large regional newspapers. The study was conducted from June 6, 2011, to April 14, 2014, and analysis was performed between December 4 and December 11, 2014.

Interventions: Pairs of patients and their partners were randomly assigned to (1) in-person intervention, (2) take-home booklet intervention, and (3) treatment-as-usual controls. An additional subgroup of patients received an electronic interactive tablet personal computer intervention. The MoleScore content was comparable across formats and consisted of demonstrations of the ABCDE (assess border, color, diameter, and evolution of pigmented lesions) rule and skills training.

Main outcomes and measures: Outcomes were self-reported SSE of the total body as well as easy-to-see and difficult-to-see regions at baseline, 4 months, and 12 months.

Results: No significant differences in SSEs were observed between the 3 intervention conditions on all of the body areas; results for all 3 intervention conditions were significantly higher than for controls at 4- and 12-month follow-ups (all P < .05). Mean (SD) body areas examined by control pairs (n = 99) at 4 months (0.98 [1.17]) and 12 months (1.82 [1.43]) were significantly less compared with examination by pairs participating in all interventions at 4 months (workbook [n = 159], 2.68 [1.19]; in-person [n = 165], 2.66 [1.11]; and tablet [n = 71], 2.53 [1.17]) and at 12 months (workbook, 2.53 [1.25]; in-person, 2.59 [1.30]; and tablet, 2.34 [1.37]) (F6,674 = 15.60; P < .001; η2 = 0.12).

Conclusions and relevance: The findings of the research support the sustainability and efficacy at 12 months of partner-assisted SSE interventions for early detection targeting individuals with a history of melanoma.

Trial registration: clinicaltrials.gov Identifier: NCT01432860.

Figure

CONSORT Diagram The CONSORT diagram presents the enrollment, randomization, and retention information about the pairs.