A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer
NCT ID: NCT04086875
Last Updated: 2024-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
332 participants
INTERVENTIONAL
2018-11-07
2024-09-24
Brief Summary
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Detailed Description
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I. Examine the efficacy of messaging for adjuvant hormone therapy compliance promotion (mAHT-CaP) in a randomized control trial (RCT) design.
SECONDARY OBJECTIVES:
I. Conduct mediator analyses of intervention efficacy..
EXPLORATORY OBJECTIVES:
I. Explore whether age (=\< 45 versus \[vs.\] \> 45 at diagnosis) and race/ethnicity (white vs. non-white) moderate intervention effects on medication adherence and symptom distress.
OUTLINE:
PHASE I: Participants attend focus groups on adherence to hormone therapy.
PHASE II: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive text messages twice weekly for 6 months to remind and motivate participants about adjuvant hormonal therapy (AHT) adherence.
GROUP II: Participants receive usual care.
After completion of study, participants are followed up at 3, 6, and 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Phase 1 (focus groups)
Participants attend focus groups on adherence to hormone therapy.
Focus Group
Participate in focus group
Questionnaire Administration
Ancillary studies
Phase II Group 1 (text messages)
Participants receive text messages twice weekly for 6 months to remind and motivate participants about AHT adherence.
Text Message
Receive text messages
Questionnaire Administration
Ancillary studies
Phase II Group II (usual care)
Participants receive usual care.
Best Practice
Receive usual care
Questionnaire Administration
Ancillary studies
Interventions
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Focus Group
Participate in focus group
Text Message
Receive text messages
Best Practice
Receive usual care
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hormone receptor positive tumor.
* Completed local definitive treatment (i.e., surgery chemotherapy, radiation).
* Within 3 month of initiation of a new adjuvant hormonal therapy (AHT) regimen.
* At least 12 months of AHT recommended.
* Able to read and understand English.
* Able to provide informed consent.
* Have a mobile device with text (TXT) capability.
* Know or willing to learn how to use TXT.
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Thomas Jefferson University
OTHER
Responsible Party
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Kuang-Yi Wen
Associate Professor - Medical Oncology
Principal Investigators
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Kuang-Yi Wen, MD
Role: PRINCIPAL_INVESTIGATOR
Sidney Kimmel Cancer Center at Thomas Jefferson University
Locations
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Jefferson Health - South Jersey
Sewell, New Jersey, United States
Jefferson Health - Abington
Abington, Pennsylvania, United States
Doylestown Hospital
Doylestown, Pennsylvania, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Jefferson Health - Northeast (Aria Torresdale)
Philadelphia, Pennsylvania, United States
Thomas Jefferson University - Methodist Hospital
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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19F.265
Identifier Type: -
Identifier Source: org_study_id
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