This clinical trial studies how well an interactive tailored website works in promoting sun protection and skin self-check behaviors in patients with stage 0-III melanoma. An internet-based program may help individuals to perform skin self-checks and engage in sun protection behaviors.
PRIMARY OBJECTIVES: I. To evaluate the impact of the interactive tailored website (ITW) versus usual care on skin self-examination (SSE) and sun protection behaviors among individuals diagnosed with melanoma. SECONDARY OBJECTIVES: I. To examine mediators of the impact of the intervention. The effects of the intervention on SSE and sun protection behaviors will be mediated by melanoma knowledge, self-efficacy for SSE and sun protection behaviors, perceived benefits of SSE and sun protection behaviors, perceived barriers to SSE and sun protection behaviors, and perceived controllability of melanoma. TERTIARY OBJECTIVES: I. To examine moderators of the impact of the intervention. To evaluate whether ITW effects are moderated by the following factors: time since diagnosis, disease stage, age, sex, income, education, Internet experience, distress about melanoma, worry about recurrence, and evaluation and usage of the ITW. OUTLINE: Phase I: Patients review draft website content materials in a semi-structured format and provide feedback via open- and closed-ended questions for the development, testing, and finalization of ITW. Phase II: Patients are randomized into 1 of 2 arms. ARM I: Patients access ITW and complete each module over 30-40 minutes. ARM II: Patients receive usual care and are then offered ITW. All patients in Phase II complete surveys over 20-40 minutes at 8, 24, and 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
485
Access ITW
Ancillary studies
Ancillary studies
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
University of Virginia
Charlottesville, Virginia, United States
Sun Protection Behavior Index
Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.
Time frame: At 24 weeks
Number of Participants That Performed a Thorough Skin Self-examination (SSE) in the Past 2 Months
Defined as thoroughly examining each area of the body during the most recent skin self-check in the last 2 months.
Time frame: 8 weeks
Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months
Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 4 months
Time frame: At 24 weeks
Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months
Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 6 months
Time frame: 48 weeks
Number of SSEs Performed
Total number of SSEs performed (regardless of their thoroughness)
Time frame: At 8, 24 and 48 weeks
Number of Body Areas Examined
Total number of body areas examined during the most recent SSE in the last 2 months
Time frame: At 8, 24 and 48 weeks
Use of Tools to Facilitate SSE
Use of a mirror, having someone else help, or using a body mole map during the most recent SSE
Time frame: At 8, 24 and 48 weeks
Frequency of Engaging in Each Individual Sun Protection Behavior From the Sun Protection Behavior Index
Frequency (from 1 = never to 5 = always) of wearing sunscreen with an SPF ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade
Time frame: At 8, 24 and 48 weeks
Number of Sunburns
Total number of sunburns received
Time frame: At 8, 24 and 48 weeks
Wearing Long Pants
Frequency (from 1 = never to 5 = always) of wearing long pants
Time frame: At 8, 24 and 48 weeks
Wearing Sunglasses
Frequency (from 1 = never to 5 = always) of wearing sunglasses
Time frame: At 8, 24 and 48 weeks
Sunbathing
Frequency (from 1 = never to 5 = always) of spending time in the sun in order to get a tan
Time frame: At 8, 24 and 48 weeks
Sun Protection Behavior Index
Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.
Time frame: Baseline
Sun Protection Behavior Index
Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.
Time frame: At 8 weeks
Sun Protection Behavior Index
Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.
Time frame: At 48 weeks
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