A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer
- Conditions
- Anatomic Stage IIIB Breast Cancer AJCC v8Estrogen Receptor Positive TumorPrognostic Stage IIIA Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8Progesterone Receptor Positive TumorAnatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8
- Interventions
- Other: Best PracticeBehavioral: Focus GroupOther: Text MessageOther: Questionnaire Administration
- Registration Number
- NCT04086875
- Lead Sponsor
- Thomas Jefferson University
- 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.
- Detailed Description
PRIMARY OBJECTIVES:
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 332
- 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.
• Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase 1 (focus groups) Questionnaire Administration Participants attend focus groups on adherence to hormone therapy. Phase II Group II (usual care) Best Practice Participants receive usual care. Phase II Group II (usual care) Questionnaire Administration Participants receive usual care. Phase 1 (focus groups) Focus Group Participants attend focus groups on adherence to hormone therapy. Phase II Group 1 (text messages) Text Message Participants receive text messages twice weekly for 6 months to remind and motivate participants about AHT adherence. Phase II Group 1 (text messages) Questionnaire Administration Participants receive text messages twice weekly for 6 months to remind and motivate participants about AHT adherence.
- Primary Outcome Measures
Name Time Method Adjuvant hormone therapy (AHT) adherence Up to 12 months 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.
Symptom distress Up to 12 months 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.
- Secondary Outcome Measures
Name Time Method Cognitive-affective barriers for AHT adherence Up to 12 months Will be developed and will test the mediating effect of cognitive affective barriers on proportion of days adherent (average over 12 months)
Cognitive-affective barriers for symptom distress Up to 12 months Will be developed and will test the mediating effect of cognitive affective barriers on the difference between baseline and 12-month symptom distress. Symptom distress is measured by the Breast Cancer Prevention Trial Symptom Scale
Trial Locations
- Locations (7)
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Jefferson Health - Northeast (Aria Torresdale)
🇺🇸Philadelphia, Pennsylvania, United States
Doylestown Hospital
🇺🇸Doylestown, Pennsylvania, United States
Jefferson Health - Abington
🇺🇸Abington, Pennsylvania, United States
Jefferson Health - South Jersey
🇺🇸Sewell, New Jersey, United States
Thomas Jefferson University - Methodist Hospital
🇺🇸Philadelphia, Pennsylvania, United States