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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

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.

Condition or disease Intervention/treatment Phase
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 Behavioral: Focus Group Other: Text Message Other: Best Practice Other: Questionnaire Administration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Mobile TXT-Based Intervention to Improve Adherence to Adjuvant Hormone Therapy and Symptom Management for BCa Survivors
Actual Study Start Date : November 7, 2018
Estimated Primary Completion Date : September 9, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 1 (focus groups)
Participants attend focus groups on adherence to hormone therapy.
Behavioral: Focus Group
Participate in focus group

Other: Questionnaire Administration
Ancillary studies

Experimental: Phase II Group 1 (text messages)
Participants receive text messages twice weekly for 6 months to remind and motivate participants about AHT adherence.
Other: Text Message
Receive text messages
Other Names:
  • SMS Text
  • SMS Text Message
  • Text

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Phase II Group II (usual care)
Participants receive usual care.
Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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


Other Outcome Measures:
  1. Perceived benefits [ Time Frame: Up to 12 months ]
    Measured by the Health Beliefs and Medication Adherence in Breast Cancer.

  2. Perceived susceptibility [ Time Frame: Up to 12 months ]
    Measured by the Health Beliefs and Medication Adherence in Breast Cancer.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086875


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

Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Kuang-Yi Wen, MD    215-503-4623    Kuang-Yi.Wen@Jefferson.edu   
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Suzanne Miller, MD    215-728-4069    Suzanne.Miller@fccc.edu   
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Kuang-Yi Wen, MD Sidney Kimmel Cancer Center at Thomas Jefferson University

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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT04086875     History of Changes
Other Study ID Numbers: 19F.265
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs