A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer
Study Details
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:
- Examine the efficacy of messaging for adjuvant hormone therapy compliance promotion (mAHT-CaP) in a randomized control trial (RCT) design.
SECONDARY OBJECTIVES:
- Conduct mediator analyses of intervention efficacy..
EXPLORATORY OBJECTIVES:
- 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 Design
Arms and Interventions
| 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:
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:
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Adjuvant hormone therapy (AHT) adherence [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 [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
- Cognitive-affective barriers for AHT adherence [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 [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
- Perceived benefits [Up to 12 months]
Measured by the Health Beliefs and Medication Adherence in Breast Cancer.
- Perceived susceptibility [Up to 12 months]
Measured by the Health Beliefs and Medication Adherence in Breast Cancer.
- Knowledge and self-efficacy for taking AHT [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 [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 [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 [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.
Eligibility Criteria
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.
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At least 12 months of AHT recommended.
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Able to read and understand English.
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Able to provide informed consent.
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Have a mobile device with text (TXT) capability.
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Know or willing to learn how to use TXT.
Exclusion Criteria:
• Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jefferson Health - South Jersey | Sewell | New Jersey | United States | 08080 |
| 2 | Jefferson Health - Abington | Abington | Pennsylvania | United States | 19001 |
| 3 | Doylestown Hospital | Doylestown | Pennsylvania | United States | 18901 |
| 4 | Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
| 5 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 6 | Jefferson Health - Northeast (Aria Torresdale) | Philadelphia | Pennsylvania | United States | 19114 |
| 7 | Thomas Jefferson University - Methodist Hospital | Philadelphia | Pennsylvania | United States | 19148 |
Sponsors and Collaborators
- Thomas Jefferson University
Investigators
- Principal Investigator: Kuang-Yi Wen, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19F.265