NCT03340532

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 30, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2021

Completed
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

2.7 years

First QC Date

November 9, 2017

Last Update Submit

May 2, 2022

Conditions

Environmental Exposure to Ultraviolet Light

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Perceived appearance vulnerability

    one month

  • Perceived health and appearance benefit

    one month

  • Perceived health vulnerability

    one month

  • SP Intentions

    one month

  • Insomnia symptoms

    one month

  • +1 more secondary outcomes

Study Arms (3)

Sleep hygiene video

PLACEBO COMPARATOR

Participants will watch a sleep hygiene video

Other: Sleep hygiene video

Information video

EXPERIMENTAL

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

Information + Appearance video

EXPERIMENTAL

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

Interventions

THE INFORMATION + APPEARANCE VIDEOOTHER

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 + Appearance video
Information SunSmart videoOTHER

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 video
Sleep hygiene videoOTHER

Contain information on better sleep hygiene

Sleep hygiene video

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Study Officials

  • Christopher Recklitis, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2017

First Posted

November 13, 2017

Study Start

January 30, 2018

Primary Completion

September 28, 2020

Study Completion

September 27, 2021

Last Updated

May 6, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)