Interactive Tailored Website to Promote Sun Protection and Skin Self-Check Behaviors in Patients With Melanoma

Not Applicable

Completed

Conditions: Stage 0 Skin Melanoma
Stage IB Skin Melanoma
Stage I Skin Melanoma
Stage IA Skin Melanoma
Stage II Skin Melanoma
Stage IIA Skin Melanoma
Stage IIIC Skin Melanoma
Stage IIIA Skin Melanoma
Stage IIB Skin Melanoma
Stage IIC Skin Melanoma

Interventions: Other: Questionnaire Administration
Other: Internet-Based Intervention
Other: Survey Administration

Registration Number: NCT03028948

Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 485

Inclusion Criteria

Phase I: Diagnosis of primary pathologic stage 0-III cutaneous malignant melanoma
Phase I: From 3-36 months post-surgical treatment
Phase I: Access to the internet
Phase I: Able to speak and read English
Phase I: Able to provide informed consent
Phase II: Diagnosis of primary pathologic stage 0-III cutaneous malignant melanoma
Phase II: From 3-24 months post-surgical treatment
Phase II: Not adherent to thorough SSE (i.e., did not check every area of the body at least once during the past 2 months)
Phase II: Not adherent to sun protection recommendations (i.e., mean score < 4 [which corresponds to "often"] on a 5-point scale [from 1 = "never" to 5 = "always"] that assesses the frequency of engaging in four sun protection behaviors)
Phase II: Access to a computer connected to the internet
Phase II: Able to speak and read English
Phase II: Able to provide informed consent

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (ITW)	Survey Administration	Patients access ITW and complete each module over 30-40 minutes. All patients in Phase II complete surveys over 20-40 minutes at 8, 24, and 48 weeks.
Arm II (usual care)	Questionnaire Administration	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.
Arm I (ITW)	Internet-Based Intervention	Patients access ITW and complete each module over 30-40 minutes. All patients in Phase II complete surveys over 20-40 minutes at 8, 24, and 48 weeks.
Arm I (ITW)	Questionnaire Administration	Patients access ITW and complete each module over 30-40 minutes. All patients in Phase II complete surveys over 20-40 minutes at 8, 24, and 48 weeks.
Arm II (usual care)	Survey Administration	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.

Primary Outcome Measures

Name	Time	Method
Sun Protection Behavior Index	At 24 weeks	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.
Number of Participants That Performed a Thorough Skin Self-examination (SSE) in the Past 2 Months	8 weeks	Defined as thoroughly examining each area of the body during the most recent skin self-check in the last 2 months.

Secondary Outcome Measures

Name	Time	Method
Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months	At 24 weeks	Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 4 months
Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months	48 weeks	Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 6 months
Number of SSEs Performed	At 8, 24 and 48 weeks	Total number of SSEs performed (regardless of their thoroughness)
Number of Body Areas Examined	At 8, 24 and 48 weeks	Total number of body areas examined during the most recent SSE in the last 2 months
Use of Tools to Facilitate SSE	At 8, 24 and 48 weeks	Use of a mirror, having someone else help, or using a body mole map during the most recent SSE
Frequency of Engaging in Each Individual Sun Protection Behavior From the Sun Protection Behavior Index	At 8, 24 and 48 weeks	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
Number of Sunburns	At 8, 24 and 48 weeks	Total number of sunburns received
Wearing Long Pants	At 8, 24 and 48 weeks	Frequency (from 1 = never to 5 = always) of wearing long pants
Wearing Sunglasses	At 8, 24 and 48 weeks	Frequency (from 1 = never to 5 = always) of wearing sunglasses
Sunbathing	At 8, 24 and 48 weeks	Frequency (from 1 = never to 5 = always) of spending time in the sun in order to get a tan
Sun Protection Behavior Index	At 48 weeks	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.

Trial Locations

Locations (2): University of Virginia
🇺🇸
Charlottesville, Virginia, United States
Rutgers Cancer Institute of New Jersey
🇺🇸
New Brunswick, New Jersey, United States