HealthSmart: Promoting Healthy Lifestyles for Young Adult Cancer Survivors Using Educational Videos

Environmental Exposure to Ultraviolet Light Clinical Trial

Official title:

HealthSmart: Promoting Healthy Lifestyles for Young Adult Cancer Survivors Using Educational Videos

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03340532
• Other study ID #: 17-515
• Secondary ID: R03CA230818-02
• Status: Completed
• Phase: N/A
• Start date: January 30, 2018
• Est. completion date: September 27, 2021

Study information

• Verified date: May 2022
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: September 27, 2021
• Est. primary completion date: September 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Environmental Exposure to Ultraviolet Light

Intervention

Other:
• THE INFORMATION + APPEARANCE VIDEO
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.
• Information SunSmart video
The INFORMATION SunSmart video providing basic information about UV risks, including secondary skin cancer and the benefits of SP, as well as specific SP recommendations and steps to integrate SP as part of routine self-care for the healthy cancer survivor
• Sleep hygiene video
Contain information on better sleep hygiene

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI), Prevent Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in SP Index scores from baseline to post-summer assessment	SP index is comprised of 15 self-report items assessing SP Behaviors	3 months
Secondary	Perceived appearance vulnerability	2 items assessing perceived likelihood that UV exposure will lead to negative appearance changes	one month
Secondary	Perceived health and appearance benefit	8 self-report items assessing expected benefits to SP	one month
Secondary	Perceived health vulnerability	2 items assessing perceived likelihood that UV exposure will lead to future skin cancers.	one month
Secondary	SP Intentions	13 items measuring intentions to practice SP	one month
Secondary	Insomnia symptoms	7 -item Insomnia Severity Scale (ISS). Total ISS scale scores range from a low of 0 (least insomnia) to a high of 28 (worst insomnia)	one month
Secondary	Change in SP Index scores from post-summer assessment to one year later	SP index is comprised of 15 self-report items assessing SP Behaviors	12-months