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Telephone-Based Intervention in Increasing Adherence to Adjuvant Hormonal Therapy in Patients With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02400060
Recruitment Status : Recruiting
First Posted : March 26, 2015
Last Update Posted : October 31, 2022
Sponsor:
Collaborator:
Alliance for Clinical Trials in Oncology
Information provided by (Responsible Party):
Michelle Naughton, Ohio State University Comprehensive Cancer Center

Study Description
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Brief Summary:
This pilot trial studies a telephone-based intervention to see if it increases adherence to adjuvant hormonal therapy in patients with breast cancer. Increasing communication between doctors and patients with breast cancer may help patients to better follow recommendations on taking adjuvant hormonal treatment medication. A telephone-based intervention may help to increase doctor-patient communication and patients' adherence to their prescribed medication.

Condition or disease Intervention/treatment Phase
Stage IA Breast Cancer Stage IB Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage 0 Breast Cancer Behavioral: Telephone-Based Intervention Other: Survey Administration Other: Laboratory Biomarker Analysis Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Pilot test intervention effects on adherence to adjuvant hormonal therapy (AHT) and explore trends in the adherence outcomes by demographic and psychosocial factors defined as acceptance, continuation, and adherence.

SECONDARY OBJECTIVES:

I. Feasibility of study design defined as recruitment rate, rate of using intervention as instructed, rate of protocol completion, and completion of psycho-social questionnaires which have been associated with adherence to AHT in the existing literature (i.e., depression, social support, pain, stress, fatigue, quality of life, pill taking attitude and behavior, perceived risk of breast cancer recurrence).

TERTIARY OBJECTIVES:

I. Surveying patients and physicians regarding their comments on the intervention components (i.e., video, text messaging, and app [application]) and overall study participation.

OUTLINE:

Patients receive daily text messages reminding them to take AHT and weekly interactive surveys delivered by a smart phone app for 3 months.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 314 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Increasing Adherence to Adjuvant Hormonal Therapy Among Breast Cancer Patients: Phase 2 - Pilot Test of Intervention for Feasibility
Actual Study Start Date : March 26, 2014
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Supportive (text messages and interactive exchanges)
Patients receive daily text messages reminding them to take AHT and weekly interactive surveys delivered by a smart phone app for 3 months.
 Behavioral: Telephone-Based Intervention
Receive text messaging

Other: Survey Administration
Ancillary studies

Other: Laboratory Biomarker Analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. Optimal usage of AHT (includes initiation, continuation and adherence) [ Time Frame: Up to 3 months ]
    Descriptive statistics will be generated. Confidence intervals (95%) for the outcomes will be generated using the Clopper-Pearson method. Logistic regression will be used to explore whether any trends are observed in the outcomes by demographic or psychosocial factors. Mediation analyses will be conducted to determine if any of the psychosocial measures are mediators of compliance.

  2. Acceptance assessed via medical records of receiving a prescription for AHT and filling it [ Time Frame: Up to 3 months ]
    Descriptive statistics will be generated. Confidence intervals (95%) for the outcomes will be generated using the Clopper-Pearson method. Logistic regression will be used to explore whether any trends are observed in the outcomes by demographic or psychosocial factors. Mediation analyses will be conducted to determine if any of the psychosocial measures are mediators of compliance.

  3. Continuation assessed via self-report of taking at least one dose per week [ Time Frame: Up to 3 months ]
    Descriptive statistics will be generated. Confidence intervals (95%) for the outcomes will be generated using the Clopper-Pearson method. Logistic regression will be used to explore whether any trends are observed in the outcomes by demographic or psychosocial factors. Mediation analyses will be conducted to determine if any of the psychosocial measures are mediators of compliance.

  4. Adherence assessed via self-report of taking the prescribed dose at least 6 of 7 days per week [ Time Frame: Up to 3 months ]
    Descriptive statistics will be generated. Confidence intervals (95%) for the outcomes will be generated using the Clopper-Pearson method. Logistic regression will be used to explore whether any trends are observed in the outcomes by demographic or psychosocial factors. Mediation analyses will be conducted to determine if any of the psychosocial measures are mediators of compliance. Weekly compliance (number of days reported taking medication) via the text messaging system will be examined longitudinally to assess whether a change over time was observed.


Secondary Outcome Measures :
  1. Change in biomarkers [ Time Frame: Baseline to 3 months ]
    Comparisons (correlations, bivariate plots) will be made between the biomarkers and self-reported rates of usage to explore the feasibility of using a biomarker to measure optimal usage in future studies.

  2. Patient and physician responses to the intervention and study participation [ Time Frame: 3 months ]
    Descriptive statistics will be generated.


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • Eligible women are those who:

    • Are post-menopausal, verified by:

      • Post bilateral surgical oophorectomy; or
      • No spontaneous menses >= 1 year; or
      • No menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
  • Are diagnosed with primary breast cancer (BC) (stages I-III)
  • Eligible to receive AHT (tamoxifen or an aromatase inhibitors [AI]) for the first time
  • Completed all primary treatment
  • Own a smartphone (in order to receive text messages and utilize the phone app)
  • Agree to receive text messages on their smartphone over a 3-month period
  • Provide consent and permission to review their medical records
  • Plan to stay in the study area for 3 months
Contacts and Locations
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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): NCT02400060


Contacts
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Contact: Ohio State University Comprehensive Cancer Center 800-293-5066 OSUCCCClinicaltrials@osumc.edu

Locations
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United States, North Carolina
Southeastern Medical Oncology Center-Goldsboro Active, not recruiting
Goldsboro, North Carolina, United States, 27534
Comprehensive Cancer Center of Wake Forest University Active, not recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Michelle Naughton, PhD, MPH    614-293-8007    Naugh04@osu.edu   
Principal Investigator: Michelle Naughton, PhD, MPH         
United States, Vermont
Fletcher Allen Health Care-Medical Center Active, not recruiting
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Alliance for Clinical Trials in Oncology
Investigators
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Principal Investigator: Michelle Naughton, PhD, MPH Ohio State University Comprehensive Cancer Center
More Information
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Additional Information:

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Responsible Party: Michelle Naughton, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02400060    
Other Study ID Numbers: OSU-13252
NCI-2014-00809 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: October 31, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Breast Carcinoma In Situ
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type