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

NCT ID: NCT03340532

Last Updated: 2022-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-30

Study Completion Date

2021-09-27

Brief Summary

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

Detailed Description

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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.

Conditions

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Environmental Exposure to Ultraviolet Light

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Sleep hygiene video

Participants will watch a sleep hygiene video

Group Type PLACEBO_COMPARATOR

Sleep hygiene video

Intervention Type OTHER

Contain information on better sleep hygiene

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

Group Type EXPERIMENTAL

Information SunSmart video

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

THE INFORMATION + APPEARANCE VIDEO

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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

Intervention Type OTHER

Sleep hygiene video

Contain information on better sleep hygiene

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Prevent Cancer Foundation

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Christopher Recklitis, Ph.D

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Recklitis, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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R03CA230818-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-515

Identifier Type: -

Identifier Source: org_study_id

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