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Interactive Tailored Website to Promote Sun Protection and Skin Self-Check Behaviors in Patients With Stage 0-III Melanoma

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ClinicalTrials.gov Identifier: NCT03028948
Recruitment Status : Active, not recruiting
First Posted : January 23, 2017
Last Update Posted : December 7, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of Virginia
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

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
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 Other: Internet-Based Intervention Other: Questionnaire Administration Other: Survey Administration Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Internet Intervention for Sun Protection and Skin Self-check Behaviors
Actual Study Start Date : March 13, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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




Primary Outcome Measures :
  1. Performance of thorough skin-self-examination (SSE) in the past 2 months [ Time Frame: At 24 weeks ]
    defined as thoroughly examining each area of the body during the most recent skin self-check in the past 2 months

  2. Sun Protection Behavior Index [ Time Frame: 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 :
  1. Performance of thorough skin-self-examination (SSE) in the past 2 months [ Time Frame: 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

  2. Performance of thorough skin-self-examination (SSE) in the past 1 month [ Time Frame: 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

  3. Number of SSEs performed [ Time Frame: At 8, 24 and 48 weeks ]
    Total number of SSEs performed (regardless of their thoroughness)

  4. Number of body areas examined [ Time Frame: At 8, 24 and 48 weeks ]
    Total number of body areas examined during the most recent SSE in the last 2 months

  5. Use of tools to facilitate SSE [ Time Frame: 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

  6. Frequency of engaging in each individual sun protection behavior from the Sun Protection Behavior Index [ Time Frame: 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

  7. Number of sunburns [ Time Frame: At 8, 24 and 48 weeks ]
    Total number of sunburns received

  8. Wearing long pants [ Time Frame: At 8, 24 and 48 weeks ]
    Frequency (from 1 = never to 5 = always) of wearing long pants

  9. Wearing sunglasses [ Time Frame: At 8, 24 and 48 weeks ]
    Frequency (from 1 = never to 5 = always) of wearing sunglasses

  10. Sunbathing [ Time Frame: 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:
  1. Distress about melanoma [ Time Frame: At 8, 24 and 48 weeks ]
    Level of distress (from 1 = not at all distressed to 10 = extremely distressed)

  2. Worry about melanoma recurrence [ Time Frame: At 8, 24 and 48 weeks ]
    Mean rating of four questions regarding worry about melanoma recurrence

  3. Perceived risk of melanoma recurrence [ Time Frame: At 8, 24 and 48 weeks ]
    Mean rating of four questions regarding perceived risk of melanoma recurrence

  4. Biopsies conducted [ Time Frame: At 48 weeks ]
    Number of biopsies conducted

  5. Indoor tanning [ Time Frame: At 48 weeks ]
    Number of times indoor tanned in the past year

  6. Diagnosis of new or recurrent skin cancers [ Time Frame: At 48 weeks ]
    Whether a new or recurrent skin cancer was diagnosed

  7. Indicators of study feasibility [ Time Frame: 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.

  8. Visits to healthcare provider related to skin surveillance [ Time Frame: At 8, 24 and 48 weeks ]
    Receipt of a physician skin examination and the reason for the visit

  9. Impact and effectiveness of the interactive tailored website [ Time Frame: At 8 weeks ]
    Perceived Internet Impact and Effectiveness Questionnaire

  10. Usage of the interactive tailored website [ Time Frame: 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).

  11. Evaluation and Utility of the interactive tailored website [ Time Frame: At 8 weeks ]
    Internet Evaluation and Perceived Utility Questionnaire and the Internet Adherence Questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028948


Locations
United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, Virginia
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)

Documents provided by Rutgers, The State University of New Jersey:
Informed Consent Form  [PDF] April 13, 2017


Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03028948     History of Changes
Other Study ID Numbers: 131403
NCI-2017-00084 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Pro2014000095
131403 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
P30CA072720 ( U.S. NIH Grant/Contract )
R01CA171666 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas