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

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

Study Overview

• Status: Completed
• Conditions: Environmental Exposure to Ultraviolet Light
• Intervention / Treatment: Other: Sleep hygiene video; Other: Information SunSmart video; Other: THE INFORMATION + APPEARANCE VIDEO

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.

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sleep hygiene video; Participants will watch a sleep hygiene video	Other: Sleep hygiene video; Contain information on better sleep hygiene
Experimental: Information 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	Other: 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
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived appearance vulnerability	2 items assessing perceived likelihood that UV exposure will lead to negative appearance changes	one month
Perceived health and appearance benefit	8 self-report items assessing expected benefits to SP	one month
Perceived health vulnerability	2 items assessing perceived likelihood that UV exposure will lead to future skin cancers.	one month
SP Intentions	13 items measuring intentions to practice SP	one month
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
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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI); Prevent Cancer Foundation
• Investigators: Principal Investigator: Christopher Recklitis, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2018
• Primary Completion (Actual): September 28, 2020
• Study Completion (Actual): September 27, 2021

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: November 9, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 17-515; R03CA230818-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No