TMD: Targeted Melanoma Detection With Skin Self-Examination During COVID-19 Restricted Physician Access

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04420273
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Arms: 2
• Actual Duration (Months): 8
• Patients Per Site Per Month: 125.8

Study Details

Study Description

Brief Summary

The purpose of this study is to reduce melanoma mortality by improving early detection of melanoma with skin self-examination (SSE) among people who self-identify as being at risk and seek care for a concerning mole. Because women are more likely than men to perform SSE, women who are engaged in health promotion by having a recent screening mammogram are the focus of this research. Self-management of melanoma detection with SSE depends on ready access to dermatologists when a concerning mole is detected. In March 2020, the Illinois stay at home order (COVID-19) prohibited non-essential health care, including screening mammography and dermatology office-based care, and both are expected to remain limited until fall 2020. This submission explores a) the effectiveness of targeted melanoma detection (TMD) among women, who identify their risk of having a melanoma, learn to perform SSE, and perform SSE, and b) the effectiveness of adhesive patch-based home sample collection for genomic analysis to rule out melanoma in moles identified by women (who received the intervention) as concerning will be explored.

Condition or Disease	Intervention/Treatment	Phase
Melanoma	Behavioral: SSE educational intervention; Behavioral: Active control:Healthy Living	N/A

Detailed Description

The proposed work will assess the effectiveness of targeted melanoma detection (TMD) with SSE education delivered remotely to women who had a screening mammogram. The effect of TMD with SSE education will be assessed with a randomized control trial among women served by Northwestern Medicine in rural, suburban and metropolitan communities. Women who identify concerning moles will choose among three options: a) watch the mole to see if the border, color or diameter of the mole changes b) send a picture of the mole to the PI for consideration of mole self-sampling, or c) make an appointment with my healthcare provider to check the mole. As required a physician will supervise women, who will perform non-invasive mole self-sampling with non-invasive adhesive patches for genomic analysis of the concerning pigmented lesion (mole). If the genomic analysis suggests that the concerning mole may be a melanoma, then the recommendation will be to have the mole biopsied.The effectiveness of acquired samples suggestive of melanoma will be examined by the obtaining the pathology reports of biopsied moles. Health care providers' (HCPs) clinical/pathologic assessment of concerning moles will be identified in the Northwestern Medicine electronic health record (EHR) system.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Control Clinical Trial Arm 1: SSE educational intervention with optional physician supervised non-invasive adhesive patch-based home sample collection of a concerning mole for genomic analysis Arm 2: Active controlRandomized Control Clinical Trial Arm 1: SSE educational intervention with optional physician supervised non-invasive adhesive patch-based home sample collection of a concerning mole for genomic analysis Arm 2: Active control
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Targeted Melanoma Detection With Skin Self-examination: Leveraging the Mammogram Encounter
• Actual Study Start Date: Jul 2, 2020
• Actual Primary Completion Date: Mar 1, 2021
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SSE educational intervention Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.	Behavioral: SSE educational intervention; Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
Active Comparator: Active control: Healthy Living Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.	Behavioral: Active control:Healthy Living; Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Completed SSE at Specified Time Points [90 days]

   Self-reported performance of SSE, a custom scale with the frequency and extent of SSE is completed in an online monthly survey

2. Number of Participants Who Identified Concerning Moles at Specified Time Points [90 days]

   Self-reported identification of concerning mole identified by user assigning scores to the border,color and diameter of the mole. A validated scoring system is used to categorize the border, color and diameter as 1 if normal, 2 if not sure, and 3 if abnormal.The sum of the scores indicates if the mole is concerning (sum of 3= benign, stop checking the mole; sum of 4- 7 monitor the mole for change in the next month; sum of 8-9 = concerning mole make an appointment to see a physician.

Secondary Outcome Measures

1. Participants' Reported Skin Self-examination Anxiety [90 days]

   Self-reported responses to 6 items, each with a 5-point Likert scale (range 6-30) higher score= more anxiety, a worse outcome

2. Participants' Confidence Performing Mole Checks [90 days]

   Self-reported responses to 7 items, each with a 5-point Likert scale (range 7-35) higher score = greater confidence (better outcome).

3. Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles [5 months]

   Electronic medical record review of physician's clinical diagnosis of concerning mole during the 3 months of the study and for 2 subsequent months

4. Pathologic Diagnosis of Concerning Moles [5 months]

   Electronic medical record review of pathologic diagnosis of biopsied moles that participants identified as concerning

5. Biopsy Performed [5 months]

   EMR review of physician performing a biopsy on a concerning mole identified by the participant, percentage of biopsies performed

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult women (aged 18 and older) with no upper age limit, who had a screening mammogram from January 1, 2019 to February 28, 2020.

• Able to read English

• Vision enough to read a newspaper

• Self-perception of their potential melanoma risk

• Willing to perform SSE either alone or with a skin check partner

• Willing to complete monthly surveys for 3 months and receive monthly text messages to personal mobile phone

• Have home Internet access and phone with ability to take a picture of a mole

• Have access to Federal Express or US Postal Service Express Mail to send mole self-sampling kits

• Willing to allow the research team access to their electronic health record to abstract physician assessment of concerning moles, biopsy results and treatment

• Willing to provide up-to-date email address, mailing address and telephone number

Inclusion criteria of skin check partner, who may be a man or a woman, to have mole self-sampled

• Male or female over the age of 18 years

• Able to read English

• Vision enough to read a newspaper

Exclusion Criteria:

• Male

• Female under the age of 18

• Unable to read English

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Feinberg School of Medicine Department of Dermatology	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: June K Robinson, MD, Northwestern University Feinberg School of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 2, 2020
• Informed Consent Form - May 31, 2020

More Information

Publications

• Robinson JK, Reavy R, Mallett KA, Turrisi R. Remote partner assisted skin self-examination skills training of melanoma survivors and their partners. Australas J Dermatol. 2019 Feb;60(1):e80-e82. doi: 10.1111/ajd.12877. Epub 2018 Jul 10.
• Robinson JK, Wayne JD, Martini MC, Hultgren BA, Mallett KA, Turrisi R. Early Detection of New Melanomas by Patients With Melanoma and Their Partners Using a Structured Skin Self-examination Skills Training Intervention: A Randomized Clinical Trial. JAMA Dermatol. 2016 Sep 1;152(9):979-85. doi: 10.1001/jamadermatol.2016.1985.

• Responsible Party: June Robinson, Research Professor of Dermatology, Northwestern University
• ClinicalTrials.gov Identifier: NCT04420273
• Other Study ID Numbers: STU00212165
• First Posted: Jun 9, 2020
• Last Update Posted: Nov 23, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Melanoma

Study Results

Participant Flow

Arm/Group Title	SSE Educational Intervention	Active Control: Healthy Living
Arm/Group Description	Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE. SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.	Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living. Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Period Title: Overall Study
STARTED	501	499
COMPLETED	390	414
NOT COMPLETED	111	85

Baseline Characteristics

Arm/Group Title	SSE Educational Intervention	Active Control: Healthy Living	Total
Arm/Group Description	Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE. SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.	Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living. Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.	Total of all reporting groups
Overall Participants	494	495	989
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	494 100%	495 100%	989 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	47.0	47.0	47.0
Sex: Female, Male (Count of Participants)
Female	494 100%	495 100%	989 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	37 7.5%	36 7.3%	73 7.4%
Not Hispanic or Latino	457 92.5%	459 92.7%	916 92.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 0.6%	3 0.6%	6 0.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 0.2%	1 0.2%	2 0.2%
White	485 98.2%	480 97%	965 97.6%
More than one race	2 0.4%	5 1%	7 0.7%
Unknown or Not Reported	3 0.6%	6 1.2%	9 0.9%
skin type (Count of Participants)
I (always sunburn, never tan)	29 5.9%	22 4.4%	51 5.2%
II (usually sunburn, tan minimally)	213 43.1%	230 46.5%	443 44.8%
III (sometimes sunburn, tan moderately)	216 43.7%	200 40.4%	416 42.1%
IV(rarely sunburn, tan deeply)	36 7.3%	43 8.7%	79 8%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Completed SSE at Specified Time Points
Description	Self-reported performance of SSE, a custom scale with the frequency and extent of SSE is completed in an online monthly survey
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

Home sample collection arm participants were randomized into arm 1 at baseline

Arm/Group Title	SSE Educational Intervention	Active Control: Healthy Living
Arm/Group Description	Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE. SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.	Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living. Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Measure Participants	494	495
baseline ever perform SSE	217 43.9%	242 48.9%
1-mo perform SSE	475 96.2%	238 48.1%
2-mo perform SSE	355 71.9%	228 46.1%
3-mo perform SSE	348 70.4%	211 42.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SSE Educational Intervention, Active Control: Healthy Living
	Comments	1-month survey
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	McNemar
	Comments	McNemar's chi-square with continuity correction

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SSE Educational Intervention, Active Control: Healthy Living
	Comments	2- months
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	McNemar
	Comments	McNemar's chi-square with continuity correction

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SSE Educational Intervention, Active Control: Healthy Living
	Comments	3-months
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	McNemar
	Comments	McNemar's chi-square with continuity correction

2. Primary Outcome

Title	Number of Participants Who Identified Concerning Moles at Specified Time Points
Description	Self-reported identification of concerning mole identified by user assigning scores to the border,color and diameter of the mole. A validated scoring system is used to categorize the border, color and diameter as 1 if normal, 2 if not sure, and 3 if abnormal.The sum of the scores indicates if the mole is concerning (sum of 3= benign, stop checking the mole; sum of 4- 7 monitor the mole for change in the next month; sum of 8-9 = concerning mole make an appointment to see a physician.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

While 494 participants were randomized to receive the intervention, only 278 participants found a concerning mole. Similarly 495 participants were randomized to the active control arm, but only 144 identified a concerning mole. Thus the number analyzed in each arm is limited to the number of participants identifying a concerning mole.

Arm/Group Title	SSE Educational Intervention	Active Control: Healthy Living
Arm/Group Description	Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE. SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.	Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living. Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Measure Participants	278	144
Made physician appointment	39 7.9%	107 21.6%
Followed mole for change	239 48.4%	7 1.4%
stopped SSE	0 0%	30 6.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SSE Educational Intervention, Active Control: Healthy Living
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

3. Secondary Outcome

Title	Participants' Reported Skin Self-examination Anxiety
Description	Self-reported responses to 6 items, each with a 5-point Likert scale (range 6-30) higher score= more anxiety, a worse outcome
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SSE Educational Intervention	Active Control: Healthy Living
Arm/Group Description	Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE. SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.	Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living. Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Measure Participants	390	414
Baseline	6.4 (0.05)	6.4 (0.05)
Follow-up month 3	6.6 (0.05)	6.6 (0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SSE Educational Intervention, Active Control: Healthy Living
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.1
	Comments
	Method	Chi-squared
	Comments

4. Secondary Outcome

Title	Participants' Confidence Performing Mole Checks
Description	Self-reported responses to 7 items, each with a 5-point Likert scale (range 7-35) higher score = greater confidence (better outcome).
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SSE Educational Intervention	Active Control: Healthy Living
Arm/Group Description	Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE. SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.	Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living. Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Measure Participants	390	414
Baseline	9.3 (0.05)	9.3 (0.05)
Follow-up-3 month	11.6 (0.05)	10.0 (0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SSE Educational Intervention, Active Control: Healthy Living
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

5. Secondary Outcome

Title	Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles
Description	Electronic medical record review of physician's clinical diagnosis of concerning mole during the 3 months of the study and for 2 subsequent months
Time Frame	5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SSE Educational Intervention	Active Control: Healthy Living
Arm/Group Description	Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE. SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.	Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living. Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Measure Participants	39	107
Clinical diagnosis benign	14 2.8%	93 18.8%
Clinical diagnosis atypical nevus	15 3%	9 1.8%
Clinical diagnosis melanoma	10 2%	5 1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SSE Educational Intervention, Active Control: Healthy Living
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

6. Secondary Outcome

Title	Pathologic Diagnosis of Concerning Moles
Description	Electronic medical record review of pathologic diagnosis of biopsied moles that participants identified as concerning
Time Frame	5 months

Outcome Measure Data

Analysis Population Description

all participants in arm 3 had benign moles on the home sample collected

Arm/Group Title	SSE Educational Intervention	Active Control: Healthy Living
Arm/Group Description	Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE. SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.	Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living. Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Measure Participants	22	14
benign nevus	0 0%	1 0.2%
atypical nevus	13 2.6%	6 1.2%
melanoma stage 0	5 1%	3 0.6%
melanoma stage 1A	4 0.8%	3 0.6%
melanoma stage 1B	0 0%	1 0.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SSE Educational Intervention, Active Control: Healthy Living
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.459
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SSE Educational Intervention, Active Control: Healthy Living
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

7. Secondary Outcome

Title	Biopsy Performed
Description	EMR review of physician performing a biopsy on a concerning mole identified by the participant, percentage of biopsies performed
Time Frame	5 months

Outcome Measure Data

Analysis Population Description

percentage of participants having a biopsy of a concerning mole

Arm/Group Title	SSE Educational Intervention	Active Control: Healthy Living
Arm/Group Description	Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE. SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.	Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living. Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Measure Participants	39	107
Number [percentage of participants having a biop]	56.4 11.4%	13.1 2.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SSE Educational Intervention, Active Control: Healthy Living
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	two months after completing final 3-month survey of study
Arm/Group Title	SSE Educational Intervention		Active Control: Healthy Living
Arm/Group Description	Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE. SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.		Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living. Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
All Cause Mortality
	SSE Educational Intervention		Active Control: Healthy Living
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/494 (0%)		0/495 (0%)
Serious Adverse Events
	SSE Educational Intervention		Active Control: Healthy Living
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/494 (0%)		0/495 (0%)
Other (Not Including Serious) Adverse Events
	SSE Educational Intervention		Active Control: Healthy Living
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/494 (0%)		0/495 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.