Breast CancerNCT03949270
Text Messaging in Patients on Adjuvant Endocrine Therapy for Breast Cancer
A study testing BETA-Text text messaging intervention in people with Breast Cancer and Adherence, Medication, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Adherence, Medication, Side Effect
- What is being tested?
- BETA-Text text messaging intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2019to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
- 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)
- 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
- Being tested
- BETA-Text text messaging intervention
- Medical subject headings
- Breast Neoplasms, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BETA-Text text messaging interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: BETA-Text text messaging intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence to endocrine therapy at one year
Measured: 1 year
Secondary outcomes (11)
Time to discontinuation of endocrine therapy
Measured: 1 year
Patient-reported Quality of life
FACT-ES (45 items). The survey assesses items on a 0-4 scale, where 0 is lack of a symptom and 4 is high degree of a symptom. There are 5 domains: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional concerns/symptoms (14 items).
Measured: 1 year
Pain (worst, least, current, average, and interference of pain)
Brief Pain Inventory (15 items), which measures worst pain, average pain, least pain, current pain, and pain interference on a 0-10 scale, where higher numbers indicate higher levels of pain.
Measured: 1 year
Treatment Burden
Overall Treatment Burden (1 item), which assess the overall burden of treatment on a 0-100 visual analog scale. Higher numbers are indicative of higher treatment burden.
Measured: 1 year
Self-Reported Adherence
Voils Extent of Non-Adherence Tool (3 items); items are scored 1-5; however, responses are dichotomized into either "adherent" (1) or "non-adherent" (2-5). A respondent must answer "1" for all three questions in order to be classified as "adherent"
Measured: 1 year
Reasons for Non-Adherence
Voils Reasons for Non-Adherence Tool (24 items). Each item is measured on a scale of 1-5, with higher scores indicating more agreement with the particular item.
Measured: 1 year
Adherence self-efficacy
SEAMS Questionnaire (13 items); items are scored 1-3 (range 13-39); the higher the score, the higher the self-efficacy of taking medication
Measured: 1 year
Financial burden
COST tool (11 items); items are scored 0-4, some items are reverse scored; the lower the score, the worse the financial toxicity.
Measured: 1 year
Beliefs about medication
BMQ tool (18 items); assessing patients' beliefs about the necessity of prescribed medication for controlling their illness and their concerns about the potential adverse consequences of taking it; higher scores indicate stronger beliefs in the concepts represented by the scale. There are an additional 8 questions which similarly address Overuse and Harm.
Measured: 1 year
Communication with one's physician
PEPPI instrument (5 items); range of scores 5-25, where high scores indicate patient-reported better patient-physician communication and interaction
Measured: 1 year
Time to onset and trend of severity of side effects
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start22 Jul 2019
- Primary completion21 Apr 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Mougalian, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949270
- Sponsor's protocol ID
- 2000024495
- Status last verified
- Nov 2023
- First submitted
- 10 May 2019
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30657377
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03949270
- Acronym / sponsor ID
- 2000024495
- Conditions
- Breast Cancer, Adherence, Medication, Side Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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)
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients in the usual care arm will not receive any text messages. |
| BETA-Text Intervention | Experimental | Behavioral: BETA-Text text messaging interventionPatients in the text messaging arm will receive daily, weekly, and monthly text messages. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BETA-Text text messaging interventionPatients 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. | Behavioural | BETA-Text Intervention |
Primary outcome
Persistence to endocrine therapy at one year
Time frame: 1 year
11 secondary outcomes
Time to discontinuation of endocrine therapy
Time frame: 1 year
Patient-reported Quality of life
Time frame: 1 year
Pain (worst, least, current, average, and interference of pain)
Time frame: 1 year
Treatment Burden
Time frame: 1 year
Self-Reported Adherence
Time frame: 1 year
Reasons for Non-Adherence
Time frame: 1 year
Adherence self-efficacy
Time frame: 1 year
Financial burden
Time frame: 1 year
Beliefs about medication
Time frame: 1 year
Communication with one's physician
Time frame: 1 year
Time to onset and trend of severity of side effects
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 30657377Mougalian 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Mougalian, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BETA-Text text messaging intervention in people with Breast Cancer and Adherence, Medication, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistence to endocrine therapy at one year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03949270, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.