Clinical trial NCT03949270: Text Messaging in Patients on Adjuvant Endocrine Therapy for Breast Cancer
Official title: BETA-Text: Evaluating the Efficacy of a Novel, Interactive, Bidirectional Text-messaging Application to Increase Persistence to Adjuvant Endocrine Therapy for Stage I-III Hormone Receptor Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Adherence, Medication
Side Effect
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 400
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: 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.


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).

Primary outcomes:
measure: Persistence to endocrine therapy at one year
timeFrame: 1 year
Secondary outcomes:
measure: Time to discontinuation of endocrine therapy
timeFrame: 1 year
measure: Patient-reported Quality of life
timeFrame: 1 year
measure: Pain (worst, least, current, average, and interference of pain)
timeFrame: 1 year
measure: Treatment Burden
timeFrame: 1 year
measure: Self-Reported Adherence
timeFrame: 1 year
measure: Reasons for Non-Adherence
timeFrame: 1 year
measure: Adherence self-efficacy
timeFrame: 1 year
measure: Financial burden
timeFrame: 1 year
measure: Beliefs about medication
timeFrame: 1 year
measure: Communication with one's physician
timeFrame: 1 year
measure: Time to onset and trend of severity of side effects
timeFrame: 1 year
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Sarah Mougalian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.