A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer
A Mobile TXT-Based Intervention to Improve Adherence to Adjuvant Hormone Therapy and Symptom Management for BCa Survivors
2 other identifiers
interventional
332
1 country
7
Brief Summary
This trial studies how well a text-based intervention works in improving adherence to hormone therapy in patients with stage I-III hormone receptor positive breast cancer. Women often require long term therapy with adjuvant hormone therapy to prevent the cancer from returning and to improve overall survival. Side effects from hormone therapy may prevent some women from staying adherent to their medication therapy. A text-based intervention may provide educational information to breast cancer patients who are undergoing adjuvant hormone therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2018
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 7, 2018
CompletedFirst Submitted
Initial submission to the registry
September 4, 2019
CompletedFirst Posted
Study publicly available on registry
September 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2024
CompletedJune 10, 2024
June 1, 2024
5.9 years
September 4, 2019
June 6, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Adjuvant hormone therapy (AHT) adherence
Assessed by wireless smart pill bottles for all participants. Daily adherence will be defined as accessing the pill bottle once per 24 hour period. Proportion adherence will be summarized by week and study arm, and presented graphically.
Up to 12 months
Symptom distress
Measured by the Breast Cancer Prevention Trial Symptom Scale, which has sound psychometric properties in breast cancer (BCa) patients. There are a total of 43 items in the scale across eight domains. Each item is a five-point Likert scale, ranging from 0 (not at all) to 4 (extremely), used to rate symptoms. Items accounting for side effects specifically related to AHT (e.g., bone pain) and other general symptoms (e.g., constipation) are added. Participants are asked whether they are bothered by each symptom and whether they think it related to their AHT or not. The two resulting scales consist of the sum of the endorsed symptom total each woman does or does not attribute to AHT.
Up to 12 months
Secondary Outcomes (2)
Cognitive-affective barriers for AHT adherence
Up to 12 months
Cognitive-affective barriers for symptom distress
Up to 12 months
Other Outcomes (6)
Perceived benefits
Up to 12 months
Perceived susceptibility
Up to 12 months
Knowledge and self-efficacy for taking AHT
Up to 12 months
- +3 more other outcomes
Study Arms (3)
Phase 1 (focus groups)
EXPERIMENTALParticipants attend focus groups on adherence to hormone therapy.
Phase II Group 1 (text messages)
EXPERIMENTALParticipants receive text messages twice weekly for 6 months to remind and motivate participants about AHT adherence.
Phase II Group II (usual care)
ACTIVE COMPARATORParticipants receive usual care.
Interventions
Receive text messages
Receive usual care
Ancillary studies
Eligibility Criteria
You may qualify if:
- Woman diagnosed with stage I-III breast cancer (BCa).
- 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.
You may not qualify if:
- Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thomas Jefferson Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (7)
Jefferson Health - South Jersey
Sewell, New Jersey, 08080, United States
Jefferson Health - Abington
Abington, Pennsylvania, 19001, United States
Doylestown Hospital
Doylestown, Pennsylvania, 18901, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Jefferson Health - Northeast (Aria Torresdale)
Philadelphia, Pennsylvania, 19114, United States
Thomas Jefferson University - Methodist Hospital
Philadelphia, Pennsylvania, 19148, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kuang-Yi Wen, MD
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor - Medical Oncology
Study Record Dates
First Submitted
September 4, 2019
First Posted
September 12, 2019
Study Start
November 7, 2018
Primary Completion
September 24, 2024
Study Completion
September 24, 2024
Last Updated
June 10, 2024
Record last verified: 2024-06