← Back to Search

SM-AET for Self-Management Action and Education Therapy (SM-AET)

N/A

Waitlist Available

Led By Rebecca Shelby, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months, 12 months, 18 months

Awards & highlights

Study Summary

This trial will test a self-management intervention for improving adherence to adjuvant endocrine therapy (AET) for breast cancer patients. The intervention is designed to meet the needs of women who are at high risk for non-adherence to AET, and will be delivered by a nurse via the telephone. Adherence to AET will be assessed over the 18 month period following study enrollment.

Eligible Conditions

Self-Management Action and Education Therapy (SM-AET)
General Health Education

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months, 12 months, 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months, 12 months, 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 12 months, 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent daily adherence assessed over 18 months

Secondary outcome measures

Change in Fatigue

Change in Menopausal Symptoms and Symptom Interference

Change in Pain and Joint Stiffness/Aching and Symptom Interference

+11 more

Other outcome measures

Treatment Credibility and Satisfaction

Trial Design

2Treatment groups

Experimental Treatment

Group I: general health education InterventionExperimental Treatment1 Intervention

general health education Intervention (control group)

Group II: SM-AETExperimental Treatment1 Intervention

a self-management intervention for enhancing skills to improve adherence and reduce symptom interference (SM-AET) (active intervention group)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

general health education

2017

N/A

~370

SM-AET

2017

N/A

~320

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,360 Previous Clinical Trials

3,420,018 Total Patients Enrolled

Rebecca Shelby, PhDPrincipal InvestigatorDuke University

3 Previous Clinical Trials

335 Total Patients Enrolled

Media Library

SM-AET Clinical Trial Eligibility Overview. Trial Name: NCT02707471 — N/A

Self-Management Action and Education Therapy (SM-AET) Research Study Groups: SM-AET, general health education Intervention

Self-Management Action and Education Therapy (SM-AET) Clinical Trial 2023: SM-AET Highlights & Side Effects. Trial Name: NCT02707471 — N/A

SM-AET 2023 Treatment Timeline for Medical Study. Trial Name: NCT02707471 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers actively recruiting new participants for this trial?

"This clinical trial is no longer actively recruiting participants, according to the information on clinicaltrials.gov. The study was originally posted on 3/14/2017 and was most recently updated on 6/22/2022. Although this clinical trial is not recruiting candidates anymore, there are 2 other trials presently enrolling participants at this time."

Answered by AI