MelanomaSSENCT03512457
Skin Self-Examination Education During Mammography
A study testing Minimal Intervention and Intensive Intervention in people with Melanoma, run by Northwestern University at 1 site in United States.
Trial summary
The skin self-examination for melanoma (SSE) educational materials were developed with the input provided by women undergoing screening mammograms. The investigators seek to evaluate the performance of SSE by women and find out if women seek care with a dermatologist for a concerning mole or for a melanoma screening… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- What is being tested?
- Minimal Intervention and Intensive Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2018to 24 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women 18 years of age or older
- Waiting to have a mammogram
Who cannot join
- Male
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: Effect of Skin Self-examination Education Delivered During the Mammography Experience.
The skin self-examination for melanoma (SSE) educational materials were developed with the input provided by women undergoing screening mammograms. The investigators seek to evaluate the performance of SSE by women and find out if women seek care with a dermatologist for a concerning mole or for a melanoma screening examination by a dermatologist after reviewing the materials received during the mammogram visit. The purpose of this study is to enhance the early detection of melanoma among women who are engaging in health promotion by having mammograms. The investigators specifically aim to evaluate the performance of SSE by women, who receive information during their mammogram appointment, and then follow-up with dermatology for a melanoma screening examination.
Read the detailed description
The proposed study is the second phase of a project assessing the feasibility and effectiveness of enhancing the early detection of melanomas among women, who are engaging in health promotion by having mammograms. The initial phase of the project framed risk messages, developed posters and brochures with the input provided by women undergoing screening mammograms, and assessed the feasibility of delivering the program during the mammogram visit at the Lynn Sage Comprehensive Breast Center of Northwestern Medicine/ Prentice Women's Hospital. The investigators seek to evaluate performance of skin self-examination (SSE) by women, who receive information during their mammogram appointment, and follow-up with dermatology for a melanoma screening examination. In the second phase, a more intensive intervention in which women will not only receive information about SSE, but will also receive a reminder to perform SSE one week after the screening mammogram and information on how to schedule an appointment with dermatology will be provided. The number of women who perform SSE at home and find a concerning mole (lesion), number who see a dermatologist, and number who have a concerning lesion biopsied will be compared in two arms of the study 1) women who receive the intensive intervention 2) women who receive the informational brochure about SSE alone. The hypothesis is that women who receive more the intensive educational intervention will be more likely to perform SSE at home and schedule a follow-up dermatologist appointment as compared to those who receive the information brochure alone. This project builds upon Robinson's successful SSE training program for melanoma patients that resulted in patients' accurate evaluations of suspicious lesions relative to dermatologists' skin examinations.
- Conditions
- Melanoma
- Being tested
- Minimal Intervention, Intensive Intervention
- Keywords
- Melanoma, Skin self-examination, mammogram
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal InterventionBehavioural
Women view an educational poster in changing room, and they receive a brochure.
Intensive InterventionBehavioural
Women view an educational poster in changing room, and they receive a brochure.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Intervention | Experimental | Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE. Receives: Behavioral: Intensive Intervention |
| Minimal Intervention | Active comparator | Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE. Receives: Behavioral: Minimal Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Performed a Skin Self-Examination at 3-months
The percentage of participants that performed skin self-examination at the 3-month time interval.
Measured: 3-months
Secondary outcomes (1)
Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion
The total number of melanomas identified by a dermatologist in women who found a concerning mole
Measured: 7-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start30 May 2018
- Primary completion24 Oct 2018
- Study completion24 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Sarah M. Friedewald, MD, Jennifer N. Choi, MD
- Responsible party
- Principal investigator, June Robinson, Northwestern University
- Investigators
- June K. Robinson, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512457
- Sponsor's protocol ID
- STU00207179
- Acronym
- SSE
- Status last verified
- Mar 2021
- First submitted
- 11 Apr 2018
- Last updated
- 13 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rzepecki AK, Jain N, Ali Y, Chavez L, Choi J, Schlosser B, Liko-Hazizi E, Friedewald SM, Robinson JK. Promoting early detection of melanoma during the mammography experience. Int J Womens Dermatol. 2017 Jul 5;3(4):195-200. doi: 10.1016/j.ijwd.2017.06.002. eCollection 2017 Dec.
PubMed 29234713Robinson JK, Perez M, Abou-El-Seoud D, Kim K, Brown Z, Liko-Hazizi E, Friedewald SM, Kwasny M, Spring B. Targeted Melanoma Screening: Risk Self-Assessment and Skin Self-Examination Education Delivered During Mammography of Women. JNCI Cancer Spectr. 2019 Jun 28;3(3):pkz047. doi: 10.1093/jncics/pkz047. eCollection 2019 Sep.
PubMed 32328556Robinson JK, Brown Z, Spring B. Melanoma Skin Self-Examination Education During Mammography: Health Burden of Women Impairs Implementation. J Cancer Educ. 2021 Aug;36(4):858-864. doi: 10.1007/s13187-020-01714-4.
PubMed 32090289
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Skin Self-examination Education Delivered During the Mammography Experience.
- ClinicalTrials.gov ID
- NCT03512457
- Acronym / sponsor ID
- SSE / STU00207179
- Conditions
- Melanoma
- Keywords
- Melanoma, Skin self-examination, mammogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Sarah M. Friedewald, MD, Jennifer N. Choi, MD
- Study start
- 30 May 2018 (actual)
- Primary completion
- 24 Oct 2018 (actual)
- Study completion
- 24 Oct 2018 (actual)
- First posted
- 30 Apr 2018 (actual)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The skin self-examination for melanoma (SSE) educational materials were developed with the input provided by women undergoing screening mammograms. The investigators seek to evaluate the performance of SSE by women and find out if women seek care with a dermatologist for a concerning mole or for a melanoma screening examination by a dermatologist after reviewing the materials received during the mammogram visit. The purpose of this study is to enhance the early detection of melanoma among women who are engaging in health promotion by having mammograms. The investigators specifically aim to evaluate the performance of SSE by women, who receive information during their mammogram appointment, and then follow-up with dermatology for a melanoma screening examination.
Detailed description
The proposed study is the second phase of a project assessing the feasibility and effectiveness of enhancing the early detection of melanomas among women, who are engaging in health promotion by having mammograms. The initial phase of the project framed risk messages, developed posters and brochures with the input provided by women undergoing screening mammograms, and assessed the feasibility of delivering the program during the mammogram visit at the Lynn Sage Comprehensive Breast Center of Northwestern Medicine/ Prentice Women's Hospital. The investigators seek to evaluate performance of skin self-examination (SSE) by women, who receive information during their mammogram appointment, and follow-up with dermatology for a melanoma screening examination. In the second phase, a more intensive intervention in which women will not only receive information about SSE, but will also receive a reminder to perform SSE one week after the screening mammogram and information on how to schedule an appointment with dermatology will be provided. The number of women who perform SSE at home and find a concerning mole (lesion), number who see a dermatologist, and number who have a concerning lesion biopsied will be compared in two arms of the study 1) women who receive the intensive intervention 2) women who receive the informational brochure about SSE alone. The hypothesis is that women who receive more the intensive educational intervention will be more likely to perform SSE at home and schedule a follow-up dermatologist appointment as compared to those who receive the information brochure alone. This project builds upon Robinson's successful SSE training program for melanoma patients that resulted in patients' accurate evaluations of suspicious lesions relative to dermatologists' skin examinations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Intervention | Experimental | Behavioral: Intensive InterventionParticipants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE. |
| Minimal Intervention | Active comparator | Behavioral: Minimal InterventionParticipants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women 18 years of age or older
- Waiting to have a mammogram
Key exclusion criteria (1 listed)
- Male
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimal InterventionWomen view an educational poster in changing room, and they receive a brochure. | Behavioural | Minimal Intervention |
| Intensive InterventionWomen view an educational poster in changing room, and they receive a brochure. | Behavioural | Intensive Intervention |
Primary outcome
Number of Participants That Performed a Skin Self-Examination at 3-months
Time frame: 3-months
The percentage of participants that performed skin self-examination at the 3-month time interval.
1 secondary outcome
Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion
Time frame: 7-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29234713Rzepecki AK, Jain N, Ali Y, Chavez L, Choi J, Schlosser B, Liko-Hazizi E, Friedewald SM, Robinson JK. Promoting early detection of melanoma during the mammography experience. Int J Womens Dermatol. 2017 Jul 5;3(4):195-200. doi: 10.1016/j.ijwd.2017.06.002. eCollection 2017 Dec.
- Results publication: PubMed 32328556Robinson JK, Perez M, Abou-El-Seoud D, Kim K, Brown Z, Liko-Hazizi E, Friedewald SM, Kwasny M, Spring B. Targeted Melanoma Screening: Risk Self-Assessment and Skin Self-Examination Education Delivered During Mammography of Women. JNCI Cancer Spectr. 2019 Jun 28;3(3):pkz047. doi: 10.1093/jncics/pkz047. eCollection 2019 Sep.
- Derived from this study: PubMed 32090289Robinson JK, Brown Z, Spring B. Melanoma Skin Self-Examination Education During Mammography: Health Burden of Women Impairs Implementation. J Cancer Educ. 2021 Aug;36(4):858-864. doi: 10.1007/s13187-020-01714-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
June K. Robinson, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal Intervention and Intensive Intervention in people with Melanoma, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Performed a Skin Self-Examination at 3-months (time frame: 3-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03512457, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.