Final Research Plan

Skin Cancer Prevention: Behavioral Counseling

June 30, 2016

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

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The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

The draft Research Plan was available for comment from March 17 until April 13, 2016 at 8:00 p.m., ET.

The analytic framework depicts the five Key Questions (KQs) described in the research plan. Specifically, it illustrates the following questions: whether counseling patients in skin cancer prevention improves intermediate outcomes (sunburn or precursor lesions) or skin cancer outcomes (melanoma, squamous or basal cell carcinoma incidence, morbidity, or mortality) (KQ1); whether primary care–relevant counseling interventions improve skin cancer prevention behaviors (reduced sun exposure, sunscreen use, protective clothing use, and skin self-examination) and avoidance of indoor tanning (KQ2); the harms of counseling interventions for skin cancer prevention (increased time in the sun, reduced physical activity, vitamin D deficiency, and anxiety) (KQ3); the association between skin self-examination and skin cancer outcomes (melanoma, squamous or basal cell carcinoma incidence, morbidity, or mortality) (KQ4); and the harms of skin self-examination (KQ5).

Text Description.

The analytic framework depicts the five Key Questions (KQs) described in the research plan. Specifically, it illustrates the following questions: whether counseling patients in skin cancer prevention improves intermediate outcomes (sunburn or precursor lesions) or skin cancer outcomes (melanoma, squamous or basal cell carcinoma incidence, morbidity, or mortality) (KQ1); whether primary care–relevant counseling interventions improve skin cancer prevention behaviors (reduced sun exposure, sunscreen use, protective clothing use, and skin self-examination) and avoidance of indoor tanning (KQ2); the harms of counseling interventions for skin cancer prevention (increased time in the sun, reduced physical activity, vitamin D deficiency, and anxiety) (KQ3); the association between skin self-examination and skin cancer outcomes (melanoma, squamous or basal cell carcinoma incidence, morbidity, or mortality) (KQ4); and the harms of skin self-examination (KQ5).

  1. Does counseling patients in skin cancer prevention improve a) intermediate outcomes (sunburn or precursor lesions) or b) skin cancer outcomes (melanoma, squamous cell, or basal cell carcinoma incidence, morbidity, or mortality)?
  2. Do primary care–relevant counseling interventions improve skin cancer prevention behaviors (e.g., reduced sun exposure, sunscreen use, protective clothing use, avoidance of indoor tanning, and skin self-examination)?
  3. What are the harms of counseling interventions for skin cancer prevention (e.g., increased time in the sun, reduced physical activity, vitamin D deficiency, and anxiety)?
  4. What is the association between skin self-examination and skin cancer outcomes (melanoma, squamous cell, or basal cell carcinoma incidence, morbidity, or mortality)?
  5. What are the harms of skin self-examination?

*Key questions (KQs) 4 and 5 will only be addressed systematically if there is sufficient evidence from KQs 1–3 that behavioral counseling increases skin self-examination behavior.

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. What is the association between sun exposure, sun protection behaviors, indoor tanning, skin self-examination, and a) skin cancer incidence, morbidity, or mortality or b) other health outcomes?

The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the KQs.

  Include Exclude
Population
  • Persons of any age
  • Parents/caregivers of children
 Persons with prior history of skin cancer or who are otherwise under surveillance for skin cancer because of known increased risk
Setting
  • Any setting linked with primary care health care delivery (e.g., home, clinic)
  • Studies conducted in countries categorized as “Very High” on the Human Development Index (as defined by the United Nations Development Programme)
 Settings not affiliated with primary care, such as community, worksite, child care, school, or recreational/tourism settings
Intervention
  • Stand-alone or multicomponent/multidimensional interventions aimed at improving sun protection behaviors or teaching skin self-examination
  • Intervention must be initiated in, conducted in, or referable from primary care
  • Interventions may include, but are not limited to: individual or group counseling, peer counseling, home visits, structured education, technology- or computer-based support, and distribution of written materials
  • Interventions may be conducted by, but are not limited to: nurses/nurse practitioners, lay health workers, and physicians
  • Health care system interventions (e.g., staff training)
  • Interventions not referable from primary care (occupational, recreational/ tourism, policy-level interventions)
  • Mass media campaigns
  • Community interventions not affiliated with primary care
  • Multicomponent interventions for which the effects of the primary care–relevant counseling component cannot be isolated
Comparison Usual care, no intervention, waitlist, or minimal intervention Another skin cancer counseling intervention
Outcomes KQs 1, 4: Skin cancer outcomes: melanoma, basal cell, or squamous cell carcinoma incidence, morbidity, or mortality; intermediate outcomes: sunburn, nevi, and actinic keratosis

KQ 2: Behavioral outcomes: sunscreen use; time spent in the sun; shade-seeking; avoiding midday sun; avoiding indoor tanning; use of protective clothing, hats, or sunglasses; composite measures of sun protection behavior; skin self-examination behavior

KQ 3: Any harm of behavioral counseling interventions, such as anxiety, increased time spent in the sun, reduced physical activity, or vitamin D deficiency

KQ 5: Any harm of skin self-examination, including overdiagnosis and cosmetic or psychosocial harms

 All KQs: Skin cancer metastasis or progression

KQs 1, 2, 4: Outcomes with less than 3 months followup after baseline assessment
Study design KQs 1, 2: Randomized and controlled clinical trials

KQs 3–5: Randomized and controlled clinical trials; prospective cohort studies

 Case-control studies, cross-sectional designs, case series, case reports, narrative reviews, commentaries, editorials, and theses; qualitative studies; ecologic studies
Language English  
Timing 2009 to present*  
Quality Fair or good (according to design-specific USPSTF criteria) Poor (according to design-specific USPSTF criteria)

* The USPSTF will continue to consider and use evidence that was included in its prior systematic reviews. For skin self-examination, the search period will begin with August 2005, the search date of the last USPSTF review on this topic.

The draft Research Plan was posted for public comment on the USPSTF Web site from March 17 to April 13, 2016. In response to public comment, the USPSTF made a few minor changes. In the analytic framework, the USPSTF added “avoidance of indoor tanning” to the behavioral outcomes to emphasize the inclusion of this sun protection behavior. In the contextual question, the USPSTF replaced “sunscreen use” with “sun protection behaviors.”  The USPSTF changed the included study designs from observational studies to case-control studies and cross-sectional designs. Finally, the USPSTF removed hospitals from the included settings.