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

Rutgers The State University of New Jersey

Status: Completed

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

Treatments: Other: Survey Administration; Other: Questionnaire Administration; Other: Internet-Based Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03028948

R01CA171666 (U.S. NIH Grant/Contract)

Pro2014000095 (Other Identifier)

131403 (Other Identifier)

NCI-2017-00084 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 485 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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485 participants in 2 patient groups

Arm I (ITW)

Experimental group

Description:

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.

Treatment:

Other: Internet-Based Intervention

Other: Questionnaire Administration

Other: Survey Administration

Arm II (usual care)

Active Comparator group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Survey Administration