Clinical trial NCT04086875: A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer
Official title: A Mobile TXT-Based Intervention to Improve Adherence to Adjuvant Hormone Therapy and Symptom Management for BCa Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
Anatomic Stage IIIC Breast Cancer AJCC v8
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
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-09-12
Enrollment: 332
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Adjuvant hormone therapy (AHT) adherence
timeFrame: Up to 12 months
measure: Symptom distress
timeFrame: Up to 12 months
Secondary outcomes:
measure: Cognitive-affective barriers for AHT adherence
timeFrame: Up to 12 months
measure: Cognitive-affective barriers for symptom distress
timeFrame: Up to 12 months
Other outcomes:
measure: Perceived benefits
timeFrame: Up to 12 months
measure: Perceived susceptibility
timeFrame: Up to 12 months
measure: Knowledge and self-efficacy for taking AHT
timeFrame: Up to 12 months
measure: Self-efficacy for managing symptoms: modified version of Lorig's Chronic Disease Self-Efficacy Scale
timeFrame: Up to 12 months
measure: Affective distress about AHT
timeFrame: Up to 12 months
measure: Social support
timeFrame: Up to 12 months
Locations:
city: Sewell
country: United States
facility: Jefferson Health - South Jersey
state: New Jersey
city: Abington
country: United States
facility: Jefferson Health - Abington
state: Pennsylvania
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Health - Northeast (Aria Torresdale)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University - Methodist Hospital
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Kuang-Yi Wen, MD
role: PRINCIPAL_INVESTIGATOR
References: