Internet-Based Intervention
OtherAccess ITW
NCT Number: NCT03028948
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Access ITW
Ancillary studies
Ancillary studies
Time frame: 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.
Time frame: 8 weeks
Defined as thoroughly examining each area of the body during the most recent skin self-check in the last 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 4 months
Time frame: 48 weeks
Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 6 months
Time frame: At 8, 24 and 48 weeks
Total number of SSEs performed (regardless of their thoroughness)
Time frame: At 8, 24 and 48 weeks
Total number of body areas examined during the most recent SSE in the last 2 months
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
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
Time frame: At 8, 24 and 48 weeks
Total number of sunburns received
Time frame: At 8, 24 and 48 weeks
Frequency (from 1 = never to 5 = always) of wearing long pants
Time frame: At 8, 24 and 48 weeks
Frequency (from 1 = never to 5 = always) of wearing sunglasses
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
Time frame: 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.
Time frame: At 8 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.
Time frame: At 48 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.
Time frame: At 8, 24 and 48 weeks
Level of distress (from 1 = not at all distressed to 10 = extremely distressed)
Time frame: At 8, 24 and 48 weeks
Mean rating of four questions regarding worry about melanoma recurrence
Time frame: At 8, 24 and 48 weeks
Mean rating of four questions regarding perceived risk of melanoma recurrence
Time frame: At 48 weeks
Number of biopsies conducted
Time frame: At 48 weeks
Number of times indoor tanned in the past year
Time frame: At 48 weeks
Whether a new or recurrent skin cancer was diagnosed
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.
Time frame: At 8, 24 and 48 weeks
Receipt of a physician skin examination and the reason for the visit
Time frame: 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.
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).
Time frame: 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.
Rutgers, The State University of New Jersey
Other
Internet Intervention for Sun Protection and Skin Self-check Behaviors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01886235
Melanoma, Neoplasms
Buffalo, New York, United States
View Trial DetailsNCT01460875
Melanoma, Neoplasms
Columbus, Ohio, United States
View Trial DetailsNCT01989559
Melanoma, Neoplasms
Portland, Oregon, United States
View Trial DetailsNCT02857374
Melanoma, Neoplasms
Buffalo, New York, United States
View Trial Details