Pilot for The Breast Cancer Endocrine Therapy Adherence (BETA) Trial

NCT02256670 | Completed

• 1 other identifier: 1409014658
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot study to assess feasibility and patient acceptance of a text message cell phone application for patients with stage I-III, hormone receptor positive breast cancer who start adjuvant endocrine therapy.

Conditions

Breast Cancer

Keywords

Hormone Receptor Positive

Outcome Measures

Primary Outcomes (2)

• Patient Acceptance of Text Message Program

  Using self-report surveys to assess feasibility and patient acceptance of text message program

  3 months

• Adherence to Endocrine Therapy

  Adherence rates after 3 months on study, compared with historical controls. Adherence is defined as taking \> 80% of prescribed pills based on self reported adherence questionnaire. This threshold was adopted from the literature. Adherence will also be assessed by checking electronic pharmacy dispensation records when feasible.

  3 months

Secondary Outcomes (1)

• Quality of Life

  3 months

Study Arms (1)

Text Message Application Intervention

EXPERIMENTAL

The study intervention will include a mobile phone two-way text message application. Each prompt described below will generate either a yes (Y)/no (N) or ABCDE(F) response from patients. Each response will generate further prompts resulting in either notification for providers to call patients or relevant phone numbers for patients to call for assistance.

Behavioral: Text Message Application

Interventions

Text Message Application BEHAVIORAL

Two-way text messaging application addressing adherence with adjuvant endocrine therapy

Also known as: MedAdherence

Text Message Application Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• Patients may enter the study before or within one month of starting endocrine treatment
• 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 a personal cell phone, agree to receive text messages on a monthly basis (including any costs), and share their personal cell phone number to receive text message reminder
• sign consent to allow research staff to contact their pharmacies to determine prescription refill dates

You may not qualify if:

• Patients with ductal carcinoma in situ

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sarah Mougalian, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 6, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 6, 2017

Record last verified: 2017-02

Locations

US (1)