NCT02457065

Brief Summary

A patient's sun-related behavior greatly influences the likelihood of that patient developing melanoma, the most dangerous form of skin cancer. Prior research shows current educational strategies on inducing preventative behaviors such as wearing sun-protection clothing and wearing sunscreen are inadequate at effectively changing behavior when used in isolation -- patients are aware of the dangers of not engaging in these preventative measures but forgo them nonetheless. The investigators are researching methods to positively influence skin cancer prevention behaviors among melanoma survivors and their families. The first objective of this study is to compare patient and familial sun exposure and cancer screening activity before and after a patient's diagnosis with primary melanoma. The second objective of this study is to note if hanging a "Melanoma Survivor" plaque in a melanoma survivor's bathroom will significantly affect the survivor's and broader family's sun exposure and cancer screening activity. The investigators' sample of patients consists of survivors of primary cutaneous melanoma less than 4.0 mm in depth who came through the Dermatology Clinic at Dartmouth-Hitchcock Medical Center and voluntarily chose to participate in the study after being informed of the nature of the research. These patients completed a confidential survey assessing sun exposure related activities immediately before and after their diagnosis. After the participants filled out the survey, the investigators asked the participants if they could nominate a family member to whom the investigators could explain the purpose of this research study to and confidentially ask an additional set of questions to evaluate the broader impact of a melanoma diagnosis. From the investigators' original sample, the investigators randomly chose a few families who would display the survivor plaque in their primary bathroom. After six-to-twelve months, during the each patient's follow up visit, the investigators asked the patient and the patient's nominated family member to fill out another survey to assess sun exposure related activity. On the surveys, no names were recorded. Everything was anonymous.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 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

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
3 years until next milestone

Results Posted

Study results publicly available

December 19, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

10 months

First QC Date

May 27, 2015

Results QC Date

May 21, 2018

Last Update Submit

December 17, 2018

Conditions

Keywords

survivorsfamily

Outcome Measures

Primary Outcomes (2)

  • Influence of a Patient's Melanoma Diagnosis on the Survivor's and Broader Family's Skin Cancer Prevention Activity.

    Subjects filled out a survey when they enrolled in the study assessing their skin cancer prevention behaviors. Survey questions asked the patient and a family member of theirs to comment on patient and familial sun exposure and cancer screening activity before and after the patient's diagnosis with primary melanoma. Subjects self-reported if the diagnosis changed their behavior.

    Collected via a survey administered immediately after a subject enrolled in the study.

  • Influence of a "Melanoma Survivor" Plaque on the Survivor's and Broader Family's Skin Cancer Prevention Activity.

    Subjects filled out a survey when they enrolled in the study assessing their skin cancer prevention behaviors. The investigators randomly gave some subjects a "Melanoma Survivor" plaque. After 6-12 months, the subjects again filled out a survey assessing their skin cancer prevention behaviors. The investigators analyzed the difference in each subject's responses to the same survey questions over time. The investigators then analyzed the difference between the responses of the subjects who saw the plaque and the subjects who did not see the plaque to discern the influence of the plaque on skin cancer prevention behaviors. Survey questions asked the patient and a family member of theirs to comment on patient and familial sun exposure and cancer screening activity. Subjects self-reported if the their behavior changed over time.

    6-12 months between time of completion of first survey and second survey.

Study Arms (2)

Receive Plaque

EXPERIMENTAL

Treatment "Melanoma Survivor" plaque: After the patients enrolled in the study and completed the initial survey, the investigators gave the patients a small 3.5 by 2 inch wooden plaque that celebrates their survival of melanoma and reminds them to engage in skin cancer prevention behaviors.

Behavioral: "Melanoma Survivor" plaque

Do Not Receive Plaque

NO INTERVENTION

Control No "Melanoma Survivor" plaque: After the patients enrolled in the study and completed the initial survey, the investigators did not give the patients a small 3.5 by 2 inch wooden plaque that celebrates their survival of melanoma and reminds them to engage in skin cancer prevention behaviors or any other intervention.

Interventions

The investigators give the patients a small 3.5 by 2 inch wooden plaque that celebrates their survival of melanoma and reminds them to engage in skin cancer prevention behaviors.

Also known as: Receive Plaque
Receive Plaque

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patient has melanoma diagnosis within past 10 years less than 4mm in depth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center (Heater Road)

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Limitations and Caveats

Did not reach anticipated sample size due to difficulties related to enrollment and patient/family-member follow up, which led to the small number of subjects analyzed.

Results Point of Contact

Title
Michael S Chapman, MD
Organization
Dartmouth-Hitchcock Medical Center

Study Officials

  • Michael S Chapman, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician, Dermatology

Study Record Dates

First Submitted

May 27, 2015

First Posted

May 29, 2015

Study Start

March 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

December 19, 2018

Results First Posted

December 19, 2018

Record last verified: 2018-12

Locations