Back to resultsText Messaging in Patients on Adjuvant Endocrine Therapy for Breast Cancer
Primary Purpose
Breast Cancer, Adherence, Medication, Side Effect
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BETA-Text text messaging intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Yale Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care
BETA-Text Intervention
Arm Description
Patients in the usual care arm will not receive any text messages.
Patients in the text messaging arm will receive daily, weekly, and monthly text messages.
Outcomes
Primary Outcome Measures
Persistence to endocrine therapy at one year
Secondary Outcome Measures
Time to discontinuation of endocrine therapy
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).
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.
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.
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"
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.
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
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.
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.
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
Time to onset and trend of severity of side effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03949270
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Adherence, Medication, Side Effect
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients in the usual care arm will not receive any text messages.
Arm Title
BETA-Text Intervention
Arm Type
Experimental
Arm Description
Patients in the text messaging arm will receive daily, weekly, and monthly text messages.
Intervention Type
Behavioral
Intervention Name(s)
BETA-Text text messaging intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Persistence to endocrine therapy at one year
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time to discontinuation of endocrine therapy
Time Frame
1 year
Title
Patient-reported Quality of life
Description
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).
Time Frame
1 year
Title
Pain (worst, least, current, average, and interference of pain)
Description
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.
Time Frame
1 year
Title
Treatment Burden
Description
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.
Time Frame
1 year
Title
Self-Reported Adherence
Description
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"
Time Frame
1 year
Title
Reasons for Non-Adherence
Description
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.
Time Frame
1 year
Title
Adherence self-efficacy
Description
SEAMS Questionnaire (13 items); items are scored 1-3 (range 13-39); the higher the score, the higher the self-efficacy of taking medication
Time Frame
1 year
Title
Financial burden
Description
COST tool (11 items); items are scored 0-4, some items are reverse scored; the lower the score, the worse the financial toxicity.
Time Frame
1 year
Title
Beliefs about medication
Description
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.
Time Frame
1 year
Title
Communication with one's physician
Description
PEPPI instrument (5 items); range of scores 5-25, where high scores indicate patient-reported better patient-physician communication and interaction
Time Frame
1 year
Title
Time to onset and trend of severity of side effects
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Facility Information:
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30657377
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.
Results Reference
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Text Messaging in Patients on Adjuvant Endocrine Therapy for Breast Cancer
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