| 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. | | Posted | | Mean | Standard Deviation | scores on a scale | | At 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | mySmartSkin | 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). | | OG001 | Usual Care | 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). |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0003.54± 0.74
- OG0013.37± 0.84
|
|
| |
| 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. | | Posted | | Count of Participants | | Participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | mySmartSkin | 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. | | OG001 | Usual Care | 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. |
| |
| 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 | | Posted | | Count of Participants | | Participants | | At 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | mySmartSkin | 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. | | OG001 | Usual Care | 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. |
| |
| 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 | | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | mySmartSkin | 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. | | OG001 | Usual Care | 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. |
| |
| Secondary | Number of SSEs Performed | Total number of SSEs performed (regardless of their thoroughness) | | Not Posted | | | | | | At 8, 24 and 48 weeks | | Participants | | | | |
| Secondary | Number of Body Areas Examined | Total number of body areas examined during the most recent SSE in the last 2 months | | Not Posted | | | | | | At 8, 24 and 48 weeks | | Participants | | | | |
| 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 | | Not Posted | | | | | | At 8, 24 and 48 weeks | | Participants | | | | |
| 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 | | Not Posted | | | | | | At 8, 24 and 48 weeks | | Participants | | | | |
| Secondary | Number of Sunburns | Total number of sunburns received | | Not Posted | | | | | | At 8, 24 and 48 weeks | | Participants | | | | |
| Secondary | Wearing Long Pants | Frequency (from 1 = never to 5 = always) of wearing long pants | | Not Posted | | | | | | At 8, 24 and 48 weeks | | Participants | | | | |
| Secondary | Wearing Sunglasses | Frequency (from 1 = never to 5 = always) of wearing sunglasses | | Not Posted | | | | | | At 8, 24 and 48 weeks | | Participants | | | | |
| Secondary | Sunbathing | Frequency (from 1 = never to 5 = always) of spending time in the sun in order to get a tan | | Not Posted | | | | | | At 8, 24 and 48 weeks | | Participants | | | | |
| Other Pre-specified | Distress About Melanoma | Level of distress (from 1 = not at all distressed to 10 = extremely distressed) | | Not Posted | | | | | | At 8, 24 and 48 weeks | | Participants | | | | |
| Other Pre-specified | Worry About Melanoma Recurrence | Mean rating of four questions regarding worry about melanoma recurrence | | Not Posted | | | | | | At 8, 24 and 48 weeks | | Participants | | | | |
| Other Pre-specified | Perceived Risk of Melanoma Recurrence | Mean rating of four questions regarding perceived risk of melanoma recurrence | | Not Posted | | | | | | At 8, 24 and 48 weeks | | Participants | | | | |
| Other Pre-specified | Biopsies Conducted | Number of biopsies conducted | | Not Posted | | | | | | At 48 weeks | | Participants | | | | |
| Other Pre-specified | Indoor Tanning | Number of times indoor tanned in the past year | | Not Posted | | | | | | At 48 weeks | | Participants | | | | |
| Other Pre-specified | Diagnosis of New or Recurrent Skin Cancers | Whether a new or recurrent skin cancer was diagnosed | | Not Posted | | | | | | At 48 weeks | | Participants | | | | |
| 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. | | Not Posted | | | | | | At 48 weeks | | Participants | | | | |
| Other Pre-specified | Visits to Healthcare Provider Related to Skin Surveillance | Receipt of a physician skin examination and the reason for the visit | | Not Posted | | | | | | At 8, 24 and 48 weeks | | Participants | | | | |
| 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. | This survey was only conducted among those who were randomized to MSS | Posted | | Mean | Standard Deviation | scores on scale | | At 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | mySmartSkin | 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). | | OG001 | Usual Care | |
| |
| 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). | | Not Posted | | | | | | At 8, 24 and 48 weeks | | Participants | | | | |
| 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. | Only the participants randomized to the intervention arm completed this survey | Posted | | Mean | Standard Deviation | scores on a scale | | At 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | mySmartSkin | 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). | | OG001 | Usual Care | |
| |
| 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. | | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | mySmartSkin | 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). | | OG001 | Usual Care | 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). |
| |
| 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. | | Posted | | Mean | Standard Deviation | scores on a scale | | At 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | mySmartSkin | 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). | | OG001 | Usual Care | 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). |
| |
| 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. | | Posted | | Mean | Standard Deviation | scores on a scale | | At 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | mySmartSkin | 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). | | OG001 | Usual Care | 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). |
| |