A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title:

A Mobile TXT-Based Intervention to Improve Adherence to Adjuvant Hormone Therapy and Symptom Management for BCa Survivors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04086875
• Other study ID #: 19F.265
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 7, 2018
• Est. completion date: May 31, 2024

Study information

• Verified date: November 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 332
• Est. completion date: May 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex).

Related Conditions & MeSH terms

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage IA Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage IIA Breast Cancer AJCC v8
• Anatomic Stage IIB Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IIIA Breast Cancer AJCC v8
• Anatomic Stage IIIB Breast Cancer AJCC v8
• Anatomic Stage IIIC Breast Cancer AJCC v8
• Breast Neoplasms
• Estrogen Receptor Positive Tumor
• Progesterone Receptor Positive Tumor
• Prognostic Stage I Breast Cancer AJCC v8
• Prognostic Stage IA Breast Cancer AJCC v8
• Prognostic Stage IB Breast Cancer AJCC v8
• Prognostic Stage II Breast Cancer AJCC v8
• Prognostic Stage IIA Breast Cancer AJCC v8
• Prognostic Stage IIB Breast Cancer AJCC v8
• Prognostic Stage III Breast Cancer AJCC v8
• Prognostic Stage IIIA Breast Cancer AJCC v8
• Prognostic Stage IIIB Breast Cancer AJCC v8
• Prognostic Stage IIIC Breast Cancer AJCC v8

Intervention

Behavioral:
• Focus Group
Participate in focus group

Other:
• Text Message
Receive text messages
• Best Practice
Receive usual care
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Jefferson Health - Abington	Abington	Pennsylvania
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Jefferson Health - Northeast (Aria Torresdale)	Philadelphia	Pennsylvania
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Thomas Jefferson University - Methodist Hospital	Philadelphia	Pennsylvania
United States	Jefferson Health - South Jersey	Sewell	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceived benefits	Measured by the Health Beliefs and Medication Adherence in Breast Cancer.	Up to 12 months
Other	Perceived susceptibility	Measured by the Health Beliefs and Medication Adherence in Breast Cancer.	Up to 12 months
Other	Knowledge and self-efficacy for taking AHT	Measured by the Medication Understanding and Use Self-Efficacy Scale. This scale is a total of 8 questions with a total score ranging from 0 to 24. It measures patients' self-efficacy in understanding and using medication.	Up to 12 months
Other	Self-efficacy for managing symptoms: modified version of Lorig's Chronic Disease Self-Efficacy Scale	Measured by a modified version of Lorig's Chronic Disease Self-Efficacy Scale for managing symptoms. The modified scale asks participants concerning their certainty of controlling symptoms caused by AHT in order to perform daily activities. The scale is a 6 item questionnaire on a 10-point Likert scale. Score is the mean of the six items, with higher scores indicating higher self-efficacy.	Up to 12 months
Other	Affective distress about AHT	Assessed by The Intrusion subscale of the Revised Impact of Events Scale, a well validated instrument that measures stress-related intrusive thoughts. The Intrusion subscale consists of 8 items with scores for each item ranging from 0 to 4.	Up to 12 months
Other	Social support	Measured using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS assesses perceptions of support received from family, friends, and significant others, which reflect distinct reliable and valid factors in BCa patient samples and medication adherence studies. This scale consists of 12 items on a 7-point Likert scale (1 very strongly disagree, 7 very strongly agree). Total score is calculated by adding the score across all items and dividing by 12. Scores of 5.1-7 are high social support.	Up to 12 months
Primary	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
Primary	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	Cognitive-affective barriers for AHT adherence	Will be developed and will test the mediating effect of cognitive affective barriers on proportion of days adherent (average over 12 months)	Up to 12 months
Secondary	Cognitive-affective barriers for symptom distress	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	Up to 12 months