Stage 0 Skin Melanoma, Stage IA Skin Melanoma, Stage IB Skin Melanoma, Stage IIA Skin Melanoma, Stage IIB Skin Melanoma, Stage IIC Skin Melanoma, Stage IIIA Skin Melanoma, Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma, Stage III Skin Melanoma, Stage II Skin Melanoma, Stage I Skin Melanoma
Conditions
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.
Interventions
OTHERInternet-Based Intervention
Access ITW
OTHERQuestionnaire Administration
Ancillary studies
OTHERSurvey Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
University of Virginia
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sun Protection Behavior Index | At 24 weeks | 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. |
| Number of Participants That Performed a Thorough Skin Self-examination (SSE) in the Past 2 Months | 8 weeks | Defined as thoroughly examining each area of the body during the most recent skin self-check in the last 2 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months | 48 weeks | Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 6 months |
| Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months | At 24 weeks | Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 4 months |
| 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 |
| Sun Protection Behavior Index | Baseline | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Worry About Melanoma Recurrence | At 8, 24 and 48 weeks | Mean rating of four questions regarding worry about 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 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. |
| 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 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. |
| Perceived Risk of Melanoma Recurrence | At 8, 24 and 48 weeks | Mean rating of four questions regarding perceived risk of melanoma recurrence |
| Distress About Melanoma | At 8, 24 and 48 weeks | Level of distress (from 1 = not at all distressed to 10 = extremely distressed) |
Countries
United States
Participant flow
Pre-assignment details
Of 485 consented participants, 441 completed baseline survey and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| mySmartSkin 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. | 224 |
| Usual Care 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. | 217 |
| Total | 441 |
Baseline characteristics
| Characteristic | mySmartSkin | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 62.0 years STANDARD_DEVIATION 12.9 | 60.8 years STANDARD_DEVIATION 13.7 | 61.4 years STANDARD_DEVIATION 13.3 |
| Annual Household Income $100,000 to $149,999 | 45 Participants | 39 Participants | 84 Participants |
| Annual Household Income ≥ $150,000 | 68 Participants | 68 Participants | 136 Participants |
| Annual Household Income ≤ $59,999 | 37 Participants | 26 Participants | 63 Participants |
| Annual Household Income $60,000 to $99,999 | 56 Participants | 53 Participants | 109 Participants |
| Annual Household Income Unknown | 18 Participants | 31 Participants | 49 Participants |
| Disease stage 0 | 67 Participants | 69 Participants | 136 Participants |
| Disease stage I | 126 Participants | 119 Participants | 245 Participants |
| Disease stage II | 18 Participants | 16 Participants | 34 Participants |
| Disease stage III | 13 Participants | 13 Participants | 26 Participants |
| Frequency of using the Internet 2 or fewer days/week | 13 Participants | 13 Participants | 26 Participants |
| Frequency of using the Internet 2 to 3 times/day | 53 Participants | 65 Participants | 118 Participants |
| Frequency of using the Internet 3 to 5 days/week | 13 Participants | 12 Participants | 25 Participants |
| Frequency of using the Internet 4 or more times/day | 98 Participants | 101 Participants | 199 Participants |
| Frequency of using the Internet Once a day | 40 Participants | 23 Participants | 63 Participants |
| Frequency of using the Internet Unknown | 7 Participants | 3 Participants | 10 Participants |
| Level of comfort using the Internet Neither comfortable nor uncomfortable | 16 Participants | 11 Participants | 27 Participants |
| Level of comfort using the Internet Somewhat comfortable | 50 Participants | 49 Participants | 99 Participants |
| Level of comfort using the Internet Somewhat uncomfortable | 15 Participants | 8 Participants | 23 Participants |
| Level of comfort using the Internet Unknown | 7 Participants | 3 Participants | 10 Participants |
| Level of comfort using the Internet Very comfortable | 126 Participants | 137 Participants | 263 Participants |
| Level of comfort using the Internet Very uncomfortable | 10 Participants | 9 Participants | 19 Participants |
| Level of Education College graduate | 70 Participants | 63 Participants | 133 Participants |
| Level of Education Graduate degree | 80 Participants | 87 Participants | 167 Participants |
| Level of Education ≤ High school graduate | 32 Participants | 22 Participants | 54 Participants |
| Level of Education Some college | 42 Participants | 45 Participants | 87 Participants |
| Marital Status Married/partnered | 179 Participants | 172 Participants | 351 Participants |
| Marital Status Not married/partnered | 45 Participants | 45 Participants | 90 Participants |
| Number of melanoma risk factors (range 0-8) | 4.3 risk factors STANDARD_DEVIATION 1.7 | 4.4 risk factors STANDARD_DEVIATION 1.6 | 4.4 risk factors STANDARD_DEVIATION 1.6 |
| Race/Ethnicity, Customized Hispanic | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic Other | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 218 Participants | 214 Participants | 432 Participants |
| Sex: Female, Male Female | 103 Participants | 113 Participants | 216 Participants |
| Sex: Female, Male Male | 121 Participants | 104 Participants | 225 Participants |
| Time since melanoma surgery 14 to 24 months | 116 Participants | 101 Participants | 217 Participants |
| Time since melanoma surgery 3 to < 14 months | 108 Participants | 116 Participants | 224 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 8 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| mySmartSkin | Number of Participants That Performed a Thorough Skin Self-examination (SSE) in the Past 2 Months | Yes | 59 Participants |
| mySmartSkin | Number of Participants That Performed a Thorough Skin Self-examination (SSE) in the Past 2 Months | No | 139 Participants |
| Usual Care | Number of Participants That Performed a Thorough Skin Self-examination (SSE) in the Past 2 Months | Yes | 16 Participants |
| Usual Care | Number of Participants That Performed a Thorough Skin Self-examination (SSE) in the Past 2 Months | No | 199 Participants |
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.
Time frame: At 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mySmartSkin | Sun Protection Behavior Index | 3.54 scores on a scale | Standard Deviation 0.74 |
| Usual Care | Sun Protection Behavior Index | 3.37 scores on a scale | Standard Deviation 0.84 |
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
Time frame: 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
Time frame: At 8, 24 and 48 weeks
Secondary
Number of SSEs Performed
Total number of SSEs performed (regardless of their thoroughness)
Time frame: At 8, 24 and 48 weeks
Secondary
Number of Sunburns
Total number of sunburns received
Time frame: At 8, 24 and 48 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
Time frame: At 24 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| mySmartSkin | Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months | Unknown | 3 Participants |
| mySmartSkin | Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months | Yes | 54 Participants |
| mySmartSkin | Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months | No | 132 Participants |
| Usual Care | Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months | Unknown | 1 Participants |
| Usual Care | Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months | Yes | 24 Participants |
| Usual Care | Performance of Thorough Skin-self-examination (SSE) in the Past 4 Months | No | 182 Participants |
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
Time frame: 48 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| mySmartSkin | Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months | Yes | 54 Participants |
| mySmartSkin | Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months | No | 121 Participants |
| mySmartSkin | Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months | Unknown | 5 Participants |
| Usual Care | Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months | Unknown | 7 Participants |
| Usual Care | Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months | Yes | 26 Participants |
| Usual Care | Performance of Thorough Skin-self-examination (SSE) in the Past 6 Months | No | 169 Participants |
Secondary
Sunbathing
Frequency (from 1 = never to 5 = always) of spending time in the sun in order to get a tan
Time frame: 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.
Time frame: At 48 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mySmartSkin | Sun Protection Behavior Index | 3.65 scores on a scale | Standard Deviation 0.72 |
| Usual Care | Sun Protection Behavior Index | 3.52 scores on a scale | Standard Deviation 0.79 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mySmartSkin | Sun Protection Behavior Index | 3.25 scores on a scale | Standard Deviation 0.75 |
| Usual Care | Sun Protection Behavior Index | 3.29 scores on a scale | Standard Deviation 0.76 |
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.
Time frame: At 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mySmartSkin | Sun Protection Behavior Index | 3.4 scores on a scale | Standard Deviation 0.78 |
| Usual Care | Sun Protection Behavior Index | 3.31 scores on a scale | Standard Deviation 0.81 |
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
Time frame: At 8, 24 and 48 weeks
Secondary
Wearing Long Pants
Frequency (from 1 = never to 5 = always) of wearing long pants
Time frame: At 8, 24 and 48 weeks
Secondary
Wearing Sunglasses
Frequency (from 1 = never to 5 = always) of wearing sunglasses
Time frame: At 8, 24 and 48 weeks
Other Pre-specified
Biopsies Conducted
Number of biopsies conducted
Time frame: At 48 weeks
Other Pre-specified
Diagnosis of New or Recurrent Skin Cancers
Whether a new or recurrent skin cancer was diagnosed
Time frame: At 48 weeks
Other Pre-specified
Distress About Melanoma
Level of distress (from 1 = not at all distressed to 10 = extremely distressed)
Time frame: At 8, 24 and 48 weeks
Other Pre-specified
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.
Time frame: At 8 weeks
Population: Only the participants randomized to the intervention arm completed this survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mySmartSkin | Evaluation and Utility of the Interactive Tailored Website | 4.3 scores on a scale | Standard Deviation 0.65 |
Other Pre-specified
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.
Time frame: At 8 weeks
Population: This survey was only conducted among those who were randomized to MSS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mySmartSkin | Impact and Effectiveness of the Interactive Tailored Website | 4.1 scores on scale | Standard Deviation 0.72 |
Other Pre-specified
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.
Time frame: At 48 weeks
Other Pre-specified
Indoor Tanning
Number of times indoor tanned in the past year
Time frame: At 48 weeks
Other Pre-specified
Perceived Risk of Melanoma Recurrence
Mean rating of four questions regarding perceived risk of melanoma recurrence
Time frame: At 8, 24 and 48 weeks
Other Pre-specified
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).
Time frame: At 8, 24 and 48 weeks
Other Pre-specified
Visits to Healthcare Provider Related to Skin Surveillance
Receipt of a physician skin examination and the reason for the visit
Time frame: At 8, 24 and 48 weeks
Other Pre-specified
Worry About Melanoma Recurrence
Mean rating of four questions regarding worry about melanoma recurrence
Time frame: At 8, 24 and 48 weeks