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

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

Tracking Information

• First Submitted Date: September 4, 2019
• First Posted Date: September 12, 2019
• Last Update Posted Date: September 12, 2019
• Actual Study Start Date: November 7, 2018
• Estimated Primary Completion Date: September 9, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: 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: A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• 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

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 10, 2019): 340
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: September 9, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Kuang-Yi Wen, MD; 215-503-4623; Kuang-Yi.Wen@Jefferson.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04086875
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Thomas Jefferson University
• Study Sponsor: Thomas Jefferson University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Kuang-Yi Wen, MD; Sidney Kimmel Cancer Center at Thomas Jefferson University

• PRS Account: Thomas Jefferson University
• Verification Date: September 2019