NCT03949270

Brief Summary

  1. 1.The primary objective is to compare rates of persistence (continuation) of any endocrine therapy (ET) between patients assigned to standard of care follow-up (control arm) versus standard of care plus a bi-directional text messaging intervention (intervention arm)
  2. 2.The secondary objectives are:

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 22, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

3.8 years

First QC Date

May 10, 2019

Last Update Submit

November 27, 2023

Conditions

Breast CancerAdherence, MedicationSide Effect

Outcome Measures

Primary Outcomes (1)

  • Persistence to endocrine therapy at one year

    1 year

Secondary Outcomes (11)

  • Time to discontinuation of endocrine therapy

    1 year

  • Patient-reported Quality of life

    1 year

  • Pain (worst, least, current, average, and interference of pain)

    1 year

  • Treatment Burden

    1 year

  • Self-Reported Adherence

    1 year

  • +6 more secondary outcomes

Study Arms (2)

Usual Care

NO INTERVENTION

Patients in the usual care arm will not receive any text messages.

BETA-Text Intervention

EXPERIMENTAL

Patients in the text messaging arm will receive daily, weekly, and monthly text messages.

Behavioral: BETA-Text text messaging intervention

Interventions

BETA-Text text messaging interventionBEHAVIORAL

Patients in the text messaging arm will receive daily, weekly, and monthly text messages. The daily message asks whether or not the patient has taken their breast cancer medication. The weekly message asks about any side effects and their severity. The monthly text message asks about any barriers that the patient might be experiencing. Concerning responses to any of the text messages will prompt contact from the office of the treating physician.

BETA-Text Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically confirmed stage I-III, estrogen and/or progesterone receptor positive, as defined by ASCO-CAP guidelines, invasive breast cancer for whom adjuvant hormonal therapy is indicated following standard NCCN practice guidelines.42
  • Patients must initiate an aromatase inhibitor (AI), with the choice of AI (letrozole, anastrozole, or exemestane) left to the discretion of the treating provider (have just started or plan to start within 4 weeks)
  • Patients with synchronous bilateral breast cancers are eligible if both tumors are hormone receptor positive.
  • Patient must be able to provide informed consent and agree to:
  • Complete questionnaires according to the pre-specified study design
  • Own or have access to a personal cell phone, agree to send and receive text messages (including any costs), and share their personal cell phone number to receive text messages.
  • Be able to read/speak English
  • To allow research staff to contact their pharmacies to determine prescription refill dates.

You may not qualify if:

  • Patients with history of prior stage I-III breast cancer in the same or contralateral breast are not eligible (because exposure to prior endocrine therapy may confound results)
  • Patients with metastatic breast cancer.
  • Patients with ductal carcinoma in situ (DCIS) or other pre-malignant lesions of the breast receiving endocrine therapy as chemoprevention.
  • Prior treatment with an aromatase inhibitor, regardless of indication.
  • Prior tamoxifen for the current cancer (prior tamoxifen for DCIS or a different cancer is permitted).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Cancer Center

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • Mougalian SS, Epstein LN, Jhaveri AP, Han G, Abu-Khalaf M, Hofstatter EW, DiGiovanna MP, Silber ALM, Adelson K, Pusztai L, Gross CP. Bidirectional Text Messaging to Monitor Endocrine Therapy Adherence and Patient-Reported Outcomes in Breast Cancer. JCO Clin Cancer Inform. 2017 Nov;1:1-10. doi: 10.1200/CCI.17.00015.

    PMID: 30657377BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsMedication Adherence

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Sarah Mougalian, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2019

First Posted

May 14, 2019

Study Start

July 22, 2019

Primary Completion

April 21, 2023

Study Completion

November 1, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)