Text Messaging in Patients on Adjuvant Endocrine Therapy for Breast Cancer

NCT ID: NCT03949270

Last Updated: 2023-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-22
• Study Completion Date: 2023-11-01

Brief Summary

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. The secondary objectives are:

(i) To assess time to permanent discontinuation of ET (switching from an aromatase inhibitor to another ET is permitted). The investigators will also account for treatment breaks.

(ii) To assess QOL at baseline, and at 6 and 12 months after initiation of ET (FACT-ES1, Brief Pain Inventory2, Overall Treatment Burden3,4, individual symptom LASA scales4) and compare between arms (iii) To assess adherence self-efficacy (SEAMS5 tool, Voils Extent of Non-Adherence Scale6), financial burden (COST tool7,8), beliefs about medications (modified BMQ tool9,10), and perceived ability to communicate with one's physician (PEPPI11 tool) and compare between arms (iv) To compare the time to endocrine therapy discontinuation in both the intervention and control arms (v) To characterize factors (including clinicopathologic features, socioeconomic status, and comorbidities) associated with non-adherence in both the intervention arm and the control arm, which may enable us to identify women who are at particularly high risk of non-adherence.

(vi) To assess adherence to medication as reported through the BETA-Text intervention (vii) To collect the time to onset and trend of severity of side effects in women assigned to the text messaging intervention.

Conditions

Breast Cancer; Adherence, Medication; Side Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

BETA-Text Intervention

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

Group Type: EXPERIMENTAL

BETA-Text text messaging intervention

Intervention Type: BEHAVIORAL

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.

Interventions

BETA-Text text messaging intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 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

2. 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)

3. Patients with synchronous bilateral breast cancers are eligible if both tumors are hormone receptor positive.

4. Patient must be able to provide informed consent and agree to:

1. Complete questionnaires according to the pre-specified study design

2. 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.

3. Be able to read/speak English

4. To allow research staff to contact their pharmacies to determine prescription refill dates.

Exclusion Criteria

1. 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)

2. Patients with metastatic breast cancer.

3. Patients with ductal carcinoma in situ (DCIS) or other pre-malignant lesions of the breast receiving endocrine therapy as chemoprevention.

4. Prior treatment with an aromatase inhibitor, regardless of indication.

5. Prior tamoxifen for the current cancer (prior tamoxifen for DCIS or a different cancer is permitted).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Mougalian, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale Cancer Center

New Haven, Connecticut, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30657377 (View on PubMed)

Other Identifiers

2000024495

Identifier Type: -

Identifier Source: org_study_id