Melanoma
Conditions
Keywords
Skin, Sunscreen, UVR Protection, 09-137
Brief summary
The purpose of this study is to understand how people make decisions about sun protection. This study is important in helping to protect against sun exposure, since it is a main risk factor for melanoma. The investigators would like to understand the decisions people make about sun protection so that they can improve their ability to help individuals who may be at risk for melanoma.
Interventions
BEHAVIORALscreening questionnaire
Phase I involves in-home interviews of 25 participants to understand the factors that affect participants' decision-making about UVR protection (sunscreen use, shade-seeking, hat use, use of protective clothing). In Phase II, we plan to recruit a sample of 60 melanoma first degree relatives (FDRs) and use an electronic narrative diary to record their daily behaviors about UVR protection. They will be asked to carry a interactive voice response (IVR) system for 14 days and they should be in the continental United States.
Sponsors
University of British Columbia
San Diego State University
Stony Brook University
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A first-degree biological relative (a child, sibling or parent) as per self report of an MSKCC follow-up surgical patient diagnosed with melanoma as per pathology report or clinician's judgment; * English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys. * 18 years of age or older; * For Phase I only: FDRs who live within a 50 mile radius of MSKCC to make it feasible for Ms. Shuk to be able to arrive at each person's home for the in-home interview without the cost being prohibitive; * For Phase I only: Can recall a period when s/he was out in the sun for at least one hour on a sunny day this past summer 2009. * For Phase I only: Can recall a separate period when s/he was out in the sun for at least one hour on a sunny day this past summer 2009, but s/he was in a different location from the period referenced above. * For Phase II only: FDRs who self-report at least 1 consecutive hour in the morning (dawn to 12:30pm) and 1 consecutive hour in the afternoon (12:30-5pm) of daily (weekend and weekday) outdoor activities on the screening questionnaire
Exclusion criteria
* First-degree relatives of melanoma patients who report never using UVR protection; * Patient's who provide consent for Phase I will not be eligible for Phase II. * Any first-degree relative of a melanoma patient who already has a first-degree relative who consented to the study; * Unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Interviewed on UVR Protection Behaviors. | 1 year | To generate models explaining decision-making about four UVR protection behaviors (sunscreen use, shade-seeking, hat use, use of protective clothing) in melanoma FDRs. This was an inductive, qualitative study using an open-ended interview to accomplish the Aim. Cohort 1 was used for this Aim. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Examine Theory-driven Affective and Cognitive Predictors of UVR Protection Maintenance (Sunscreen Use, Shade-seeking, Hat Use, and Use of UVR Protective Clothing)Assessed in Real Time. | 1 year | To examine theory-driven affective and cognitive predictors of UVR protection maintenance (sunscreen use, shade-seeking, hat use, and use of UVR protective clothing) assessed in real time. Phase 1 was not assessed for this Outcome Measure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Phase I: 25 Melanoma FDRs This study will involve two phases. Guided by EDTM, we will first build models of decision-making about UVR protection (sunscreen use, shade-seeking, hat use, use of protective clothing)using in-home ethnographic interviews with 25 melanoma FDRs (Phase I). In Phase II, we will test the validity of each composite model. This will be completed using EMA data collection with 60 different melanoma FDRs from Phase I who will report on their sunscreen use, shade-seeking, use of hat, and use of UVR protective clothing and decision-making regarding these outcomes via interactive voice response (IVR) system and audio narrative diaries (using a digital voice recorder). We will examine the validity of each model and examine the influence of theory-driven affective and cognitive predictors of UVR protection maintenance across time.
screening questionnaire: Phase I involves in-home interviews of 25 participants to understand the factors that affect participants' decision-making about UVR protection (sunscreen use, shade-seeking, hat use, use of protective clothing). In Phase II, we plan to recruit a sample of 60 melanoma first degree relatives (FDRs) and use an electronic narrative diary to record their daily behaviors about UVR protection. They will be asked to carry a interactive voice response (IVR) system for 14 days and they should be in the continental United States. | 25 |
| Phase II: 60 Melanoma FDRs This study will involve two phases. Guided by EDTM, we will first build models of decision-making about UVR protection (sunscreen use, shade-seeking, hat use, use of protective clothing)using in-home ethnographic interviews with 25 melanoma FDRs (Phase I). In Phase II, we will test the validity of each composite model. This will be completed using EMA data collection with 60 different melanoma FDRs from Phase I who will report on their sunscreen use, shade-seeking, use of hat, and use of UVR protective clothing and decision-making regarding these outcomes via interactive voice response (IVR) system and audio narrative diaries (using a digital voice recorder). We will examine the validity of each model and examine the influence of theory-driven affective and cognitive predictors of UVR protection maintenance across time.
screening questionnaire: Phase I involves in-home interviews of 25 participants to understand the factors that affect participants' decision-making about UVR protection (sunscreen use, shade-seeking, hat use, use of protective clothing). In Phase II, we plan to recruit a sample of 60 melanoma first degree relatives (FDRs) and use an electronic narrative diary to record their daily behaviors about UVR protection. They will be asked to carry a interactive voice response (IVR) system for 14 days and they should be in the continental United States. | 59 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 11 |
| Overall Study | Withdrawal by Subject | 0 | 5 |
Baseline characteristics
| Characteristic | Cohort 1: Phase I: 25 Melanoma FDRs | Total | Phase II: 60 Melanoma FDRs |
|---|---|---|---|
| Age, Continuous | 39 years | 45 years | 48 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 81 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 25 Participants | 83 Participants | 58 Participants |
| Region of Enrollment United States | 25 Participants | 84 Participants | 59 Participants |
| Sex: Female, Male Female | 12 Participants | 50 Participants | 38 Participants |
| Sex: Female, Male Male | 13 Participants | 34 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 59 |
| other Total, other adverse events | 0 / 25 | 0 / 59 |
| serious Total, serious adverse events | 0 / 25 | 0 / 59 |
Outcome results
Primary
Number of Participants Interviewed on UVR Protection Behaviors.
To generate models explaining decision-making about four UVR protection behaviors (sunscreen use, shade-seeking, hat use, use of protective clothing) in melanoma FDRs. This was an inductive, qualitative study using an open-ended interview to accomplish the Aim. Cohort 1 was used for this Aim.
Time frame: 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Phase I: 25 Melanoma FDRs | Number of Participants Interviewed on UVR Protection Behaviors. | Number of participants interviewed | 25 Participants |
| Cohort 1: Phase I: 25 Melanoma FDRs | Number of Participants Interviewed on UVR Protection Behaviors. | Number of participants not interviewed | 0 Participants |
| Phase II: 60 Melanoma FDRs | Number of Participants Interviewed on UVR Protection Behaviors. | Number of participants interviewed | 0 Participants |
| Phase II: 60 Melanoma FDRs | Number of Participants Interviewed on UVR Protection Behaviors. | Number of participants not interviewed | 59 Participants |
Secondary
To Examine Theory-driven Affective and Cognitive Predictors of UVR Protection Maintenance (Sunscreen Use, Shade-seeking, Hat Use, and Use of UVR Protective Clothing)Assessed in Real Time.
To examine theory-driven affective and cognitive predictors of UVR protection maintenance (sunscreen use, shade-seeking, hat use, and use of UVR protective clothing) assessed in real time. Phase 1 was not assessed for this Outcome Measure.
Time frame: 1 year
Population: Phase 1 was not assessed for this Outcome Measure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Phase I: 25 Melanoma FDRs | To Examine Theory-driven Affective and Cognitive Predictors of UVR Protection Maintenance (Sunscreen Use, Shade-seeking, Hat Use, and Use of UVR Protective Clothing)Assessed in Real Time. | Women who use sunscreen in cooler weather | 0 Participants |
| Cohort 1: Phase I: 25 Melanoma FDRs | To Examine Theory-driven Affective and Cognitive Predictors of UVR Protection Maintenance (Sunscreen Use, Shade-seeking, Hat Use, and Use of UVR Protective Clothing)Assessed in Real Time. | Men who skip sunscreen in cooler weather and in shade while wearing a hat | 0 Participants |
| Cohort 1: Phase I: 25 Melanoma FDRs | To Examine Theory-driven Affective and Cognitive Predictors of UVR Protection Maintenance (Sunscreen Use, Shade-seeking, Hat Use, and Use of UVR Protective Clothing)Assessed in Real Time. | Women who skip sunscreen in cooler weather and in shade while wearing a hat | 0 Participants |
| Cohort 1: Phase I: 25 Melanoma FDRs | To Examine Theory-driven Affective and Cognitive Predictors of UVR Protection Maintenance (Sunscreen Use, Shade-seeking, Hat Use, and Use of UVR Protective Clothing)Assessed in Real Time. | Men who skip sunscreen on sunny days and in shade while wearing a hat | 0 Participants |
| Phase II: 60 Melanoma FDRs | To Examine Theory-driven Affective and Cognitive Predictors of UVR Protection Maintenance (Sunscreen Use, Shade-seeking, Hat Use, and Use of UVR Protective Clothing)Assessed in Real Time. | Men who skip sunscreen on sunny days and in shade while wearing a hat | 10 Participants |
| Phase II: 60 Melanoma FDRs | To Examine Theory-driven Affective and Cognitive Predictors of UVR Protection Maintenance (Sunscreen Use, Shade-seeking, Hat Use, and Use of UVR Protective Clothing)Assessed in Real Time. | Women who use sunscreen in cooler weather | 9 Participants |
| Phase II: 60 Melanoma FDRs | To Examine Theory-driven Affective and Cognitive Predictors of UVR Protection Maintenance (Sunscreen Use, Shade-seeking, Hat Use, and Use of UVR Protective Clothing)Assessed in Real Time. | Women who skip sunscreen in cooler weather and in shade while wearing a hat | 23 Participants |
| Phase II: 60 Melanoma FDRs | To Examine Theory-driven Affective and Cognitive Predictors of UVR Protection Maintenance (Sunscreen Use, Shade-seeking, Hat Use, and Use of UVR Protective Clothing)Assessed in Real Time. | Men who skip sunscreen in cooler weather and in shade while wearing a hat | 21 Participants |