Clinical trial NCT03028948: Interactive Tailored Website to Promote Sun Protection and Skin Self-Check Behaviors in Patients With Melanoma
Official title: Internet Intervention for Sun Protection and Skin Self-check Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stage 0 Skin Melanoma
Stage I Skin Melanoma
Stage IA Skin Melanoma
Stage IB Skin Melanoma
Stage II Skin Melanoma
Stage IIA Skin Melanoma
Stage IIB Skin Melanoma
Stage IIC Skin Melanoma
Stage III Skin Melanoma
Stage IIIA Skin Melanoma
Stage IIIB Skin Melanoma
Stage IIIC Skin Melanoma
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Virginia
First posted: 2017-01-23
Enrollment: 485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Sun Protection Behavior Index
timeFrame: At 24 weeks
measure: Number of Participants That Performed a Thorough Skin Self-examination (SSE) in the Past 2 Months
timeFrame: 8 weeks
Secondary outcomes:
measure: Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months
timeFrame: At 24 weeks
measure: Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months
timeFrame: 48 weeks
measure: Number of SSEs Performed
timeFrame: At 8, 24 and 48 weeks
measure: Number of Body Areas Examined
timeFrame: At 8, 24 and 48 weeks
measure: Use of Tools to Facilitate SSE
timeFrame: At 8, 24 and 48 weeks
measure: Frequency of Engaging in Each Individual Sun Protection Behavior From the Sun Protection Behavior Index
timeFrame: At 8, 24 and 48 weeks
measure: Number of Sunburns
timeFrame: At 8, 24 and 48 weeks
measure: Wearing Long Pants
timeFrame: At 8, 24 and 48 weeks
measure: Wearing Sunglasses
timeFrame: At 8, 24 and 48 weeks
measure: Sunbathing
timeFrame: At 8, 24 and 48 weeks
measure: Sun Protection Behavior Index
timeFrame: Baseline
measure: Sun Protection Behavior Index
timeFrame: At 8 weeks
measure: Sun Protection Behavior Index
timeFrame: At 48 weeks
Other outcomes:
measure: Distress About Melanoma
timeFrame: At 8, 24 and 48 weeks
measure: Worry About Melanoma Recurrence
timeFrame: At 8, 24 and 48 weeks
measure: Perceived Risk of Melanoma Recurrence
timeFrame: At 8, 24 and 48 weeks
measure: Biopsies Conducted
timeFrame: At 48 weeks
measure: Indoor Tanning
timeFrame: At 48 weeks
measure: Diagnosis of New or Recurrent Skin Cancers
timeFrame: At 48 weeks
measure: Indicators of Study Feasibility
timeFrame: At 48 weeks
measure: Visits to Healthcare Provider Related to Skin Surveillance
timeFrame: At 8, 24 and 48 weeks
measure: Impact and Effectiveness of the Interactive Tailored Website
timeFrame: At 8 weeks
measure: Usage of the Interactive Tailored Website
timeFrame: At 8, 24 and 48 weeks
measure: Evaluation and Utility of the Interactive Tailored Website
timeFrame: At 8 weeks
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Elliot Coups
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coups EJ, Manne SL, Ohman Strickland P, Hilgart M, Goydos JS, Heckman CJ, Chamorro P, Rao BK, Davis M, Smith FO, Thorndike FP, Ritterband LM. Randomized controlled trial of the mySmartSkin web-based intervention to promote skin self-examination and sun protection behaviors among individuals diagnosed with melanoma: study design and baseline characteristics. Contemp Clin Trials. 2019 Aug;83:117-127. doi: 10.1016/j.cct.2019.06.014. Epub 2019 Jun 27.