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

Stage IIIC Skin Melanoma Clinical Trial

Official title:

Internet Intervention for Sun Protection and Skin Self-check Behaviors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03028948
• Other study ID #: 131403
• Secondary ID: NCI-2017-00084Pr
• Status: Completed
• Phase: N/A
• Start date: March 13, 2017
• Est. completion date: July 12, 2019

Study information

• Verified date: February 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 485
• Est. completion date: July 12, 2019
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Skin Neoplasms
• 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

Intervention

Other:
• Internet-Based Intervention
Access ITW
• Questionnaire Administration
Ancillary studies
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI), University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Distress About Melanoma	Level of distress (from 1 = not at all distressed to 10 = extremely distressed)	At 8, 24 and 48 weeks
Other	Worry About Melanoma Recurrence	Mean rating of four questions regarding worry about melanoma recurrence	At 8, 24 and 48 weeks
Other	Perceived Risk of Melanoma Recurrence	Mean rating of four questions regarding perceived risk of melanoma recurrence	At 8, 24 and 48 weeks
Other	Biopsies Conducted	Number of biopsies conducted	At 48 weeks
Other	Indoor Tanning	Number of times indoor tanned in the past year	At 48 weeks
Other	Diagnosis of New or Recurrent Skin Cancers	Whether a new or recurrent skin cancer was diagnosed	At 48 weeks
Other	Indicators of Study Feasibility	Ineligibility rate and reasons, recruitment rate and reasons for refusal, differences in sociodemographic factors between study decliners and those recruited, dropout rate and reasons.	At 48 weeks
Other	Visits to Healthcare Provider Related to Skin Surveillance	Receipt of a physician skin examination and the reason for the visit	At 8, 24 and 48 weeks
Other	Impact and Effectiveness of the Interactive Tailored Website	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.	At 8 weeks
Other	Usage of the Interactive Tailored Website	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).	At 8, 24 and 48 weeks
Other	Evaluation and Utility of the Interactive Tailored Website	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.	At 8 weeks
Primary	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.	At 24 weeks
Primary	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.	8 weeks
Secondary	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	At 24 weeks
Secondary	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	48 weeks
Secondary	Number of SSEs Performed	Total number of SSEs performed (regardless of their thoroughness)	At 8, 24 and 48 weeks
Secondary	Number of Body Areas Examined	Total number of body areas examined during the most recent SSE in the last 2 months	At 8, 24 and 48 weeks
Secondary	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	At 8, 24 and 48 weeks
Secondary	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	At 8, 24 and 48 weeks
Secondary	Number of Sunburns	Total number of sunburns received	At 8, 24 and 48 weeks
Secondary	Wearing Long Pants	Frequency (from 1 = never to 5 = always) of wearing long pants	At 8, 24 and 48 weeks
Secondary	Wearing Sunglasses	Frequency (from 1 = never to 5 = always) of wearing sunglasses	At 8, 24 and 48 weeks
Secondary	Sunbathing	Frequency (from 1 = never to 5 = always) of spending time in the sun in order to get a tan	At 8, 24 and 48 weeks
Secondary	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.	Baseline
Secondary	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.	At 8 weeks
Secondary	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.	At 48 weeks