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出境医 / 临床实验 / Text Messaging in Patients on Adjuvant Endocrine Therapy for Breast Cancer

Text Messaging in Patients on Adjuvant Endocrine Therapy for Breast Cancer

Study Description
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.


Condition or disease Intervention/treatment Phase
Breast Cancer Adherence, Medication Side Effect Behavioral: BETA-Text text messaging intervention Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022
Arms and Interventions
Arm Intervention/treatment
No Intervention: Usual Care
Patients in the usual care arm will not receive any text messages.
Experimental: BETA-Text Intervention
Patients in the text messaging arm will receive daily, weekly, and monthly text messages.
Behavioral: 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.

Outcome Measures
Primary Outcome Measures :
  1. Persistence to endocrine therapy at one year [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Time to discontinuation of endocrine therapy [ Time Frame: 1 year ]
  2. Patient-reported Quality of life [ Time Frame: 1 year ]
    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).

  3. Pain (worst, least, current, average, and interference of pain) [ Time Frame: 1 year ]
    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.

  4. Treatment Burden [ Time Frame: 1 year ]
    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.

  5. Self-Reported Adherence [ Time Frame: 1 year ]
    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"

  6. Reasons for Non-Adherence [ Time Frame: 1 year ]
    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.

  7. Adherence self-efficacy [ Time Frame: 1 year ]
    SEAMS Questionnaire (13 items); items are scored 1-3 (range 13-39); the higher the score, the higher the self-efficacy of taking medication

  8. Financial burden [ Time Frame: 1 year ]
    COST tool (11 items); items are scored 0-4, some items are reverse scored; the lower the score, the worse the financial toxicity.

  9. Beliefs about medication [ Time Frame: 1 year ]
    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.

  10. Communication with one's physician [ Time Frame: 1 year ]
    PEPPI instrument (5 items); range of scores 5-25, where high scores indicate patient-reported better patient-physician communication and interaction

  11. Time to onset and trend of severity of side effects [ Time Frame: 1 year ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
Contacts and Locations

Locations
Layout table for location information
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06511
Contact: Sarah Mougalian    203-785-2876    sarah.mougalian@yale.edu   
Contact       sarah.mougalian@yale.edu   
Principal Investigator: Sarah S Mougalian, MD         
Sponsors and Collaborators
Yale University
Tracking Information
First Submitted Date  ICMJE May 10, 2019
First Posted Date  ICMJE May 14, 2019
Last Update Posted Date May 5, 2020
Actual Study Start Date  ICMJE July 22, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
Persistence to endocrine therapy at one year [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
  • Time to discontinuation of endocrine therapy [ Time Frame: 1 year ]
  • Patient-reported Quality of life [ Time Frame: 1 year ]
    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) [ Time Frame: 1 year ]
    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 [ Time Frame: 1 year ]
    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 [ Time Frame: 1 year ]
    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 [ Time Frame: 1 year ]
    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 [ Time Frame: 1 year ]
    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 [ Time Frame: 1 year ]
    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 [ Time Frame: 1 year ]
    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 [ Time Frame: 1 year ]
    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 [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Text Messaging in Patients on Adjuvant Endocrine Therapy for Breast Cancer
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Cancer
  • Adherence, Medication
  • Side Effect
Intervention  ICMJE Behavioral: 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.
Study Arms  ICMJE
  • No Intervention: Usual Care
    Patients in the usual care arm will not receive any text messages.
  • Experimental: BETA-Text Intervention
    Patients in the text messaging arm will receive daily, weekly, and monthly text messages.
    Intervention: Behavioral: BETA-Text text messaging intervention
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2019)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03949270
Other Study ID Numbers  ICMJE 2000024495
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yale University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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