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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

Primary Purpose

Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Focus Group
Text Message
Best Practice
Questionnaire Administration
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anatomic Stage I Breast Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Jefferson Health - South JerseyRecruiting
  • Jefferson Health - AbingtonRecruiting
  • Doylestown HospitalRecruiting
  • Sidney Kimmel Cancer Center at Thomas Jefferson UniversityRecruiting
  • Fox Chase Cancer CenterRecruiting
  • Jefferson Health - Northeast (Aria Torresdale)
  • Thomas Jefferson University - Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Phase 1 (focus groups)

Phase II Group 1 (text messages)

Phase II Group II (usual care)

Arm Description

Participants attend focus groups on adherence to hormone therapy.

Participants receive text messages twice weekly for 6 months to remind and motivate participants about AHT adherence.

Participants receive usual care.

Outcomes

Primary Outcome Measures

Adjuvant hormone therapy (AHT) adherence
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
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

Cognitive-affective barriers for AHT adherence
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
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

Full Information

First Posted
September 4, 2019
Last Updated
September 14, 2022
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT04086875
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1 (focus groups)
Arm Type
Experimental
Arm Description
Participants attend focus groups on adherence to hormone therapy.
Arm Title
Phase II Group 1 (text messages)
Arm Type
Experimental
Arm Description
Participants receive text messages twice weekly for 6 months to remind and motivate participants about AHT adherence.
Arm Title
Phase II Group II (usual care)
Arm Type
Active Comparator
Arm Description
Participants receive usual care.
Intervention Type
Behavioral
Intervention Name(s)
Focus Group
Intervention Description
Participate in focus group
Intervention Type
Other
Intervention Name(s)
Text Message
Other Intervention Name(s)
SMS Text, SMS Text Message, Text
Intervention Description
Receive text messages
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive usual care
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Adjuvant hormone therapy (AHT) adherence
Description
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.
Time Frame
Up to 12 months
Title
Symptom distress
Description
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.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Cognitive-affective barriers for AHT adherence
Description
Will be developed and will test the mediating effect of cognitive affective barriers on proportion of days adherent (average over 12 months)
Time Frame
Up to 12 months
Title
Cognitive-affective barriers for symptom distress
Description
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
Time Frame
Up to 12 months
Other Pre-specified Outcome Measures:
Title
Perceived benefits
Description
Measured by the Health Beliefs and Medication Adherence in Breast Cancer.
Time Frame
Up to 12 months
Title
Perceived susceptibility
Description
Measured by the Health Beliefs and Medication Adherence in Breast Cancer.
Time Frame
Up to 12 months
Title
Knowledge and self-efficacy for taking AHT
Description
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.
Time Frame
Up to 12 months
Title
Self-efficacy for managing symptoms: modified version of Lorig's Chronic Disease Self-Efficacy Scale
Description
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.
Time Frame
Up to 12 months
Title
Affective distress about AHT
Description
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.
Time Frame
Up to 12 months
Title
Social support
Description
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.
Time Frame
Up to 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuang-Yi Wen, MD
Phone
215-503-4623
Email
Kuang-Yi.Wen@Jefferson.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuang-Yi Wen, MD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jefferson Health - South Jersey
City
Sewell
State/Province
New Jersey
ZIP/Postal Code
08080
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Maria Lopez, MD
Email
AnaMaria.Lopez@jefferson.edu
Facility Name
Jefferson Health - Abington
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pooja Suresh, MD
Email
Pooja.Suresh@jefferson.edu
Facility Name
Doylestown Hospital
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Heacock
Email
LXH086@jefferson.edu
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuang-Yi Wen, MD
Phone
215-503-4623
Email
Kuang-Yi.Wen@Jefferson.edu
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Miller, MD
Phone
215-728-4069
Email
Suzanne.Miller@fccc.edu
Facility Name
Jefferson Health - Northeast (Aria Torresdale)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Zibelli, MD
Email
Allison.Zibelli@jefferson.edu
Facility Name
Thomas Jefferson University - Methodist Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Zibelli, MD
Email
Allison.Zibelli@jefferson.edu

12. IPD Sharing Statement

Learn more about this trial

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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