Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Melanoma, Cutaneous Malignant

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

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.

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.

Internet-Based Intervention

Questionnaire Administration

Survey Administration

Elliot Coups

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.

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

Internet Intervention for Sun Protection and Skin Self-check Behaviors

Level of distress (from 1 = not at all distressed to 10 = extremely distressed)

Mean rating of four questions regarding worry about melanoma recurrence

Mean rating of four questions regarding perceived risk of melanoma recurrence

Number of times indoor tanned in the past year

Whether a new or recurrent skin cancer was diagnosed

Ineligibility rate and reasons, recruitment rate and reasons for refusal, differences in sociodemographic factors between study decliners and those recruited, dropout rate and reasons.

Receipt of a physician skin examination and the reason for the visit

Perceived Internet Impact and Effectiveness Questionnaire was used. This 20-item survey was used to measure the degree to which MSS helped the participant learn how to be prepared to conduct SSE and engage in sun protection behaviors as well as feel in control of his/her health and feel less worried about melanoma. A Likert scale was used for each question (1=not at all, 2=slightly, 3=somewhat, 4=mostly, 5=very). The scores from each question were averaged to compute the total scale score for each participant. The total scores for each participant were also averaged to find the overall average across MSS participants. Higher values represent greater effectiveness of the program.

Number of visits to the website, the number of monthly skin self-checks completed, the number of updates to the sun-safe action plan, and starting/completing the remaining sections of the website (Introduction; Getting Ready to Do a Skin Self-Check; Practice Sun-Safe Behaviors).

Internet Evaluation and Perceived Utility Questionnaire and the Internet Adherence Questionnaire was used. This 15-item survey assessed the program characteristics, including usefulness, convenience, ease of use, worry about privacy, ease of navigation, and satisfaction with the program. A Likert scale was used for each question (1=not at all, 2=slightly, 3=somewhat, 4=mostly, 5=very). The scores from each question were averaged to compute the total scale score for each participant. The total scores for each participant were also averaged to find the overall average across MSS participants. Higher values represent higher scores in terms of utility and evaluation of the program.

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.

Defined as thoroughly examining each area of the body during the most recent skin self-check in the last 2 months.

Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 4 months

Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 6 months

Total number of SSEs performed (regardless of their thoroughness)

Total number of body areas examined during the most recent SSE in the last 2 months

Use of a mirror, having someone else help, or using a body mole map during the most recent SSE

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

Frequency (from 1 = never to 5 = always) of wearing long pants

Frequency (from 1 = never to 5 = always) of wearing sunglasses

Frequency (from 1 = never to 5 = always) of spending time in the sun in order to get a tan

National Cancer Institute (NCI)

University of Virginia

Rutgers, The State University of New Jersey

Professor and Associate Director of Population Science

Adverse events were not monitored/assessed. There is no risk for participating in this study and, therefore, zero participants are at risk of facing an adverse event.

Of 485 enrolled individuals, 224 were randomized to MSS.

These individuals access MSS content and complete the three educational Cores. Individuals completed surveys at baseline, 8 weeks, 24 weeks and 48 weeks.

mySmartSkin

Of the 485 enrolled individuals, 217 were randomized to the UC condition.

These participants received the usual clinical follow-up care. Individuals completed surveys at baseline, 8 weeks, 24 weeks and 48 weeks.

Usual Care

Total

Age, Continuous

Sex: Female, Male

Non-Hispanic White

Non-Hispanic Black

Non-Hispanic Other

Hispanic

Race/Ethnicity, Customized

≤ High school graduate

Some college

College graduate

Graduate degree

Level of Education

≤ $59,999

$60,000 to $99,999

$100,000 to $149,999

≥ $150,000

Unknown

Annual Household Income

Married/partnered

Not married/partnered

Marital Status

2 or fewer days/week

3 to 5 days/week

Once a day

2 to 3 times/day

4 or more times/day

Frequency of using the Internet

Very uncomfortable

Somewhat uncomfortable

Neither comfortable nor uncomfortable

Somewhat comfortable

Very comfortable

Level of comfort using the Internet

Number of melanoma risk factors (range 0-8)

3 to < 14 months

14 to 24 months

Time since melanoma surgery

Disease stage refers to primary pathologic stage of cutaneous malignant melanoma that the participant was diagnosed with. In this study, stage 0 and I are considered early stage melanoma. Earlier stages are associated with better outcomes and less serious disease.

Disease stage

Findings may be less generalizable to those with low sun protection behavior. We recruited from one state so participant pool may not represent the US population. SSE and sun protection were assessed using self-report. Sun content was in the last core and reviewed by fewer participants. Sample was primarily non-Hispanic white.

Dr. Sharon Manne

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, 5=always).

Sun Protection Behavior Index

Performance of a thorough SSE was defined as examining every area of the body during the most recent SSE. Participants reported if they had checked each part of their body for signs of cancer through a yes/no question response in the last 2 months and 6 months.

Number of Participants That Performed a Thorough Skin Self-examination (SSE) in the Past 2 Months

Performance of a thorough SSE was defined as examining every area of the body during the most recent SSE. Participants reported if they had checked each part of their body for signs of cancer through a yes/no question response in the last 4 months.

Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months

Performance of a thorough SSE was defined as examining every area of the body during the most recent SSE. Participants reported if they had checked each part of their body for signs of cancer through a yes/no question response in the last 6 months.

Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months

Number of SSEs Performed

Number of Body Areas Examined

Use of Tools to Facilitate SSE

Frequency of Engaging in Each Individual Sun Protection Behavior From the Sun Protection Behavior Index

Number of Sunburns

Wearing Long Pants

Wearing Sunglasses

Sunbathing

Distress About Melanoma

Worry About Melanoma Recurrence

Perceived Risk of Melanoma Recurrence

Biopsies Conducted

Indoor Tanning

Diagnosis of New or Recurrent Skin Cancers

Indicators of Study Feasibility

Visits to Healthcare Provider Related to Skin Surveillance

At the 8 week follow-up, participants enrolled in the MSS intervention completed a 20-item Impact and Effectiveness measure assessing the degree to which MSS helped the participant learn how to be prepared to conduct SSE and engage in sun protection behaviors as well as feel in control of his/her health and feel less worried about melanoma (1=not at all, 5=very).

This survey was only conducted among those who were randomized to MSS

Impact and Effectiveness of the Interactive Tailored Website

Usage of the Interactive Tailored Website

At the 8 week follow-up, participants enrolled in the MSS intervention completed a 15-item Evaluation and Utility survey, which assessed program characteristics, including usefulness, convenience, ease of use, worry about privacy, ease of navigation, and satisfaction with the program (1=not at all, 5=very).

Spots Global Cancer Trial Database for stage i skin melanoma