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A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer

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ClinicalTrials.gov Identifier: NCT04086875
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Tracking Information
First Submitted Date  ICMJE September 4, 2019
First Posted Date  ICMJE September 12, 2019
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE November 7, 2018
Estimated Primary Completion Date September 9, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2019)
  • Adjuvant hormone therapy (AHT) adherence [ Time Frame: Up to 12 months ]
    Assessed by wireless smart pill bottles for all participants. Daily adherence will be defined as accessing the pill bottle once per 24 hour period. Proportion adherence will be summarized by week and study arm, and presented graphically.
  • Symptom distress [ Time Frame: Up to 12 months ]
    Measured by the Breast Cancer Prevention Trial Symptom Scale, which has sound psychometric properties in breast cancer (BCa) patients. There are a total of 43 items in the scale across eight domains. Each item is a five-point Likert scale, ranging from 0 (not at all) to 4 (extremely), used to rate symptoms. Items accounting for side effects specifically related to AHT (e.g., bone pain) and other general symptoms (e.g., constipation) are added. Participants are asked whether they are bothered by each symptom and whether they think it related to their AHT or not. The two resulting scales consist of the sum of the endorsed symptom total each woman does or does not attribute to AHT.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2019)
  • Cognitive-affective barriers for AHT adherence [ Time Frame: Up to 12 months ]
    Will be developed and will test the mediating effect of cognitive affective barriers on proportion of days adherent (average over 12 months)
  • Cognitive-affective barriers for symptom distress [ Time Frame: Up to 12 months ]
    Will be developed and will test the mediating effect of cognitive affective barriers on the difference between baseline and 12-month symptom distress. Symptom distress is measured by the Breast Cancer Prevention Trial Symptom Scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 10, 2019)
  • Perceived benefits [ Time Frame: Up to 12 months ]
    Measured by the Health Beliefs and Medication Adherence in Breast Cancer.
  • Perceived susceptibility [ Time Frame: Up to 12 months ]
    Measured by the Health Beliefs and Medication Adherence in Breast Cancer.
  • Knowledge and self-efficacy for taking AHT [ Time Frame: Up to 12 months ]
    Measured by the Medication Understanding and Use Self-Efficacy Scale. This scale is a total of 8 questions with a total score ranging from 0 to 24. It measures patients' self-efficacy in understanding and using medication.
  • Self-efficacy for managing symptoms: modified version of Lorig's Chronic Disease Self-Efficacy Scale [ Time Frame: Up to 12 months ]
    Measured by a modified version of Lorig's Chronic Disease Self-Efficacy Scale for managing symptoms. The modified scale asks participants concerning their certainty of controlling symptoms caused by AHT in order to perform daily activities. The scale is a 6 item questionnaire on a 10-point Likert scale. Score is the mean of the six items, with higher scores indicating higher self-efficacy.
  • Affective distress about AHT [ Time Frame: Up to 12 months ]
    Assessed by The Intrusion subscale of the Revised Impact of Events Scale, a well validated instrument that measures stress-related intrusive thoughts. The Intrusion subscale consists of 8 items with scores for each item ranging from 0 to 4.
  • Social support [ Time Frame: Up to 12 months ]
    Measured using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS assesses perceptions of support received from family, friends, and significant others, which reflect distinct reliable and valid factors in BCa patient samples and medication adherence studies. This scale consists of 12 items on a 7-point Likert scale (1 very strongly disagree, 7 very strongly agree). Total score is calculated by adding the score across all items and dividing by 12. Scores of 5.1-7 are high social support.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer
Official Title  ICMJE A Mobile TXT-Based Intervention to Improve Adherence to Adjuvant Hormone Therapy and Symptom Management for BCa Survivors
Brief Summary This trial studies how well a text-based intervention works in improving adherence to hormone therapy in patients with stage I-III hormone receptor positive breast cancer. Women often require long term therapy with adjuvant hormone therapy to prevent the cancer from returning and to improve overall survival. Side effects from hormone therapy may prevent some women from staying adherent to their medication therapy. A text-based intervention may provide educational information to breast cancer patients who are undergoing adjuvant hormone therapy.
Detailed Description

PRIMARY OBJECTIVES:

I. Examine the efficacy of messaging for adjuvant hormone therapy compliance promotion (mAHT-CaP) in a randomized control trial (RCT) design.

SECONDARY OBJECTIVES:

I. Conduct mediator analyses of intervention efficacy..

EXPLORATORY OBJECTIVES:

I. Explore whether age (=< 45 versus [vs.] > 45 at diagnosis) and race/ethnicity (white vs. non-white) moderate intervention effects on medication adherence and symptom distress.

OUTLINE:

PHASE I: Participants attend focus groups on adherence to hormone therapy.

PHASE II: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive text messages twice weekly for 6 months to remind and motivate participants about adjuvant hormonal therapy (AHT) adherence.

GROUP II: Participants receive usual care.

After completion of study, participants are followed up at 3, 6, and 12 months.

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
  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage IIA Breast Cancer AJCC v8
  • Anatomic Stage IA Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Anatomic Stage IIB Breast Cancer AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Estrogen Receptor Positive Tumor
  • Progesterone Receptor Positive Tumor
  • Prognostic Stage I Breast Cancer AJCC v8
  • Prognostic Stage IA Breast Cancer AJCC v8
  • Prognostic Stage IB Breast Cancer AJCC v8
  • Prognostic Stage II Breast Cancer AJCC v8
  • Prognostic Stage IIA Breast Cancer AJCC v8
  • Prognostic Stage IIB Breast Cancer AJCC v8
  • Prognostic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Prognostic Stage IIIC Breast Cancer AJCC v8
Intervention  ICMJE
  • Behavioral: Focus Group
    Participate in focus group
  • Other: Text Message
    Receive text messages
    Other Names:
    • SMS Text
    • SMS Text Message
    • Text
  • Other: Best Practice
    Receive usual care
    Other Names:
    • standard of care
    • standard therapy
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE
  • Experimental: Phase 1 (focus groups)
    Participants attend focus groups on adherence to hormone therapy.
    Interventions:
    • Behavioral: Focus Group
    • Other: Questionnaire Administration
  • Experimental: Phase II Group 1 (text messages)
    Participants receive text messages twice weekly for 6 months to remind and motivate participants about AHT adherence.
    Interventions:
    • Other: Text Message
    • Other: Questionnaire Administration
  • Active Comparator: Phase II Group II (usual care)
    Participants receive usual care.
    Interventions:
    • Other: Best Practice
    • Other: Questionnaire Administration
Publications * Not Provided

*   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: September 10, 2019)
340
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date September 9, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Woman diagnosed with stage I-III breast cancer (BCa).
  • Hormone receptor positive tumor.
  • Completed local definitive treatment (i.e., surgery chemotherapy, radiation).
  • Within 3 month of initiation of a new adjuvant hormonal therapy (AHT) regimen.
  • At least 12 months of AHT recommended.
  • Able to read and understand English.
  • Able to provide informed consent.
  • Have a mobile device with text (TXT) capability.
  • Know or willing to learn how to use TXT.

Exclusion Criteria:

• Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex).

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kuang-Yi Wen, MD 215-503-4623 Kuang-Yi.Wen@Jefferson.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04086875
Other Study ID Numbers  ICMJE 19F.265
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 Not Provided
Responsible Party Thomas Jefferson University
Study Sponsor  ICMJE Thomas Jefferson University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kuang-Yi Wen, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
PRS Account Thomas Jefferson University
Verification Date September 2019

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