Clinical trial NCT03340532: HealthSmart: Promoting Healthy Lifestyles for Young Adult Cancer Survivors Using Educational Videos
Official title: HealthSmart: Promoting Healthy Lifestyles for Young Adult Cancer Survivors Using Educational Videos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Environmental Exposure to Ultraviolet Light
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Prevent Cancer Foundation
First posted: 2017-11-13
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to view one of two SunSmart educational videos or a control video on sleep hygiene. In the three months following the video intervention, participants' sun protection attitudes and behaviors are assessed. An additional measure of sun protection behaviors 12-months later will be provided by participants who participate in the optional 1-year follow-up.
Primary purpose: OTHER

Brief summary: To assess the efficacy of the two SunSmart intervention videos to change sun protection attitudes and behaviors

Detailed description: SunSmart is a novel video intervention designed to prevent secondary skin cancer in young adult cancer survivors by increasing their adherence to recommended sun protection.

This study will assess two versions of the SunSmart video intervention. These are: 1) The INFORMATION VIDEO providing basic information about UV risks, including secondary skin cancer and the benefits of sun protection (SP), as well as specific SP recommendations and steps to integrate SP as part of routine self-care for the healthy cancer survivor; and 2) THE INFORMATION + APPEARANCE VIDEO which will include the full information video, along with an additional embedded video segment emphasizing negative appearance consequences of UV exposure. Primary aim of the study is to assess the impact of the video intervention on sun protection intentions and behavior in young adult cancer survivors compared to a control intervention. Secondary aims are to describe the impact of the appearance information when included in the SunSmart intervention, to investigate the extent to which the intervention changes sun protection through hypothesized mediating variables, and to describe the consistency of sleep behaviors over time in cancer survivors.

Eligibility criteria: Inclusion Criteria:

* History of cancer diagnosis at least one year prior
* Current age 18-35
* No cancer therapy in the prior 3 months (excluding chemoprevention agents)
* No future cancer therapy planned
* Able to read and write in English
* Not compliant with recommended sun protection, as determined by at least one of the following criteria:

  1. Any intentional sunbathing, artificial tanning or a sunburn in the past 5 years; OR
  2. Having a moderate to light complexion (Fitzpatrick skin types I-IV), and not using sunscreen ≥ 90% of the time during incidental sun exposure.

Exclusion Criteria:

* History of skin cancer diagnosis
* Enrolled on DFCI protocol 17-385 or any other sun protection intervention in the past 5 years.
* Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all measures independently

Primary outcomes:
measure: Change in SP Index scores from baseline to post-summer assessment
timeFrame: 3 months
Secondary outcomes:
measure: Perceived appearance vulnerability
timeFrame: one month
measure: Perceived health and appearance benefit
timeFrame: one month
measure: Perceived health vulnerability
timeFrame: one month
measure: SP Intentions
timeFrame: one month
measure: Insomnia symptoms
timeFrame: one month
measure: Change in SP Index scores from post-summer assessment to one year later
timeFrame: 12-months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christopher Recklitis, MD
role: PRINCIPAL_INVESTIGATOR
References: