Interactive Tailored Website to Promote Sun Protection and Skin Self-Check Behaviors in Patients With Melanoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I (ITW) 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. |
Other: Internet-Based Intervention
Access ITW
Other: Questionnaire Administration
Ancillary studies
Other: Survey Administration
Ancillary studies
|
| Active Comparator: Arm II (usual care) 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. |
Other: Questionnaire Administration
Ancillary studies
Other: Survey Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Performance of thorough skin-self-examination (SSE) in the past 2 months [At 24 weeks]
defined as thoroughly examining each area of the body during the most recent skin self-check in the past 2 months
- Sun Protection Behavior Index [At 24 weeks]
Mean rating of the frequency (from 1 = never to 5 = always) of engaging in each of four sun protection behaviors: wearing sunscreen with an SPF ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade
Secondary Outcome Measures
- Performance of thorough skin-self-examination (SSE) in the past 2 months [At 8 and 48 weeks]
Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 2 months
- Performance of thorough skin-self-examination (SSE) in the past 1 month [At 8, 24 and 48 weeks]
Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 1 month
- 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
Other Outcome Measures
- Distress about melanoma [At 8, 24 and 48 weeks]
Level of distress (from 1 = not at all distressed to 10 = extremely distressed)
- Worry about melanoma recurrence [At 8, 24 and 48 weeks]
Mean rating of four questions regarding worry about melanoma recurrence
- Perceived risk of melanoma recurrence [At 8, 24 and 48 weeks]
Mean rating of four questions regarding perceived risk of melanoma recurrence
- Biopsies conducted [At 48 weeks]
Number of biopsies conducted
- Indoor tanning [At 48 weeks]
Number of times indoor tanned in the past year
- Diagnosis of new or recurrent skin cancers [At 48 weeks]
Whether a new or recurrent skin cancer was diagnosed
- Indicators of study feasibility [At 48 weeks]
Ineligibility rate and reasons, recruitment rate and reasons for refusal, differences in sociodemographic factors between study decliners and those recruited, dropout rate and reasons.
- Visits to healthcare provider related to skin surveillance [At 8, 24 and 48 weeks]
Receipt of a physician skin examination and the reason for the visit
- Impact and effectiveness of the interactive tailored website [At 8 weeks]
Perceived Internet Impact and Effectiveness Questionnaire
- Usage of the interactive tailored website [At 8, 24 and 48 weeks]
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).
- Evaluation and Utility of the interactive tailored website [At 8 weeks]
Internet Evaluation and Perceived Utility Questionnaire and the Internet Adherence Questionnaire
Eligibility Criteria
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)
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
| 2 | University of Virginia | Charlottesville | Virginia | United States | 22904 |
Sponsors and Collaborators
- Rutgers, The State University of New Jersey
- National Cancer Institute (NCI)
- University of Virginia
Investigators
- Principal Investigator: Elliot Coups, Rutgers Cancer Institute of New Jersey
Study Documents (Full-Text)
More Information
Publications
None provided.- Pro2014000095
- NCI-2017-00084
- Pro2014000095
- 131403
- R01CA171666