Melanoma
Conditions
Keywords
skin self-examination, SSE, melanoma
Brief 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.
Interventions
BEHAVIORALSkin Self Examination Information and ABCDE Rule
Card with condensed information about skin self examination (SSE) and color illustrations of the ABCDE (asymmetry of shape, border irregularity, color variation, diameter \> or equal to 6 mm, and evolution of the lesion) rule. A research assistant gave a skill demonstration using a magnifying lens.
Sponsors
Loyola University
Dartmouth-Hitchcock Medical Center
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Skin Examinations Without Partner Over 4 Months | 4 months | Behavioral outcome was measured by assessing the number of times that participants examined their skin in the last 4 months. |
| Mean Number of Skin Examinations With Partner Over 4 Months | 4 months | Behavioral outcome was measured by assessing the number of times that participants examined their skin with a partner in the last 4 months. |
| Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months | 4 months | Behavioral outcome was measured by assessing the number of times that participants reviewed skin self examination guidelines in the last 4 months. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from hospital registries of patients who were diagnosed as having cutaneous melanoma (CM) and were being seen at least annually by physicians for their skin conditions.
Participants by arm
| Arm | Count |
|---|---|
| Solo Learning Participant learning alone (without partner). | 65 |
| Dyadic Learning Participant and partner learning together. | 65 |
| Total | 130 |
Baseline characteristics
| Characteristic | Solo Learning | Dyadic Learning | Total |
|---|---|---|---|
| Age, Customized <=18 years | 0 participants | 0 participants | 0 participants |
| Age, Customized >=70 years | 11 participants | 4 participants | 15 participants |
| Age, Customized Between 18 and 69 years | 54 participants | 61 participants | 115 participants |
| Region of Enrollment United States | 65 participants | 65 participants | 130 participants |
| Sex: Female, Male Female | 32 Participants | 33 Participants | 65 Participants |
| Sex: Female, Male Male | 33 Participants | 32 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 65 | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 | 0 / 65 |
Outcome results
Primary
Mean Number of Skin Examinations Without Partner Over 4 Months
Behavioral outcome was measured by assessing the number of times that participants examined their skin in the last 4 months.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Solo Learning Baseline | Mean Number of Skin Examinations Without Partner Over 4 Months | 0.02 Times examined skin by self | Standard Deviation 0.12 |
| Dyadic Learning Baseline | Mean Number of Skin Examinations Without Partner Over 4 Months | 0.00 Times examined skin by self | Standard Deviation 0 |
| Solo Learning Immediate Follow-up | Mean Number of Skin Examinations Without Partner Over 4 Months | 0.02 Times examined skin by self | Standard Deviation 0.12 |
| Dyadic Learning Immediate Follow-up | Mean Number of Skin Examinations Without Partner Over 4 Months | 0.00 Times examined skin by self | Standard Deviation 0 |
| Solo Learning 4-Month Follow-up | Mean Number of Skin Examinations Without Partner Over 4 Months | 0.23 Times examined skin by self | Standard Deviation 0.42 |
| Dyadic Learning 4-Month Follow-up | Mean Number of Skin Examinations Without Partner Over 4 Months | 0.80 Times examined skin by self | Standard Deviation 0.74 |
Primary
Mean Number of Skin Examinations With Partner Over 4 Months
Behavioral outcome was measured by assessing the number of times that participants examined their skin with a partner in the last 4 months.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Solo Learning Baseline | Mean Number of Skin Examinations With Partner Over 4 Months | 0.0 Times examined skin with a partner | Standard Deviation 0 |
| Dyadic Learning Baseline | Mean Number of Skin Examinations With Partner Over 4 Months | 0.0 Times examined skin with a partner | Standard Deviation 0 |
| Solo Learning Immediate Follow-up | Mean Number of Skin Examinations With Partner Over 4 Months | 0.0 Times examined skin with a partner | Standard Deviation 0 |
| Dyadic Learning Immediate Follow-up | Mean Number of Skin Examinations With Partner Over 4 Months | 0.0 Times examined skin with a partner | Standard Deviation 0 |
| Solo Learning 4-Month Follow-up | Mean Number of Skin Examinations With Partner Over 4 Months | 0.23 Times examined skin with a partner | Standard Deviation 0.42 |
| Dyadic Learning 4-Month Follow-up | Mean Number of Skin Examinations With Partner Over 4 Months | 0.81 Times examined skin with a partner | Standard Deviation 0.72 |
Primary
Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months
Behavioral outcome was measured by assessing the number of times that participants reviewed skin self examination guidelines in the last 4 months.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Solo Learning Baseline | Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months | .03 Number of times reviewed SSE guidelines | Standard Deviation 0.17 |
| Dyadic Learning Baseline | Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months | 0.0 Number of times reviewed SSE guidelines | Standard Deviation 0 |
| Solo Learning Immediate Follow-up | Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months | 0.08 Number of times reviewed SSE guidelines | Standard Deviation 0.27 |
| Dyadic Learning Immediate Follow-up | Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months | 0.0 Number of times reviewed SSE guidelines | Standard Deviation 0 |
| Solo Learning 4-Month Follow-up | Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months | 0.55 Number of times reviewed SSE guidelines | Standard Deviation 0.53 |
| Dyadic Learning 4-Month Follow-up | Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months | 0.91 Number of times reviewed SSE guidelines | Standard Deviation 0.68 |