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



Status:Completed
Conditions:Breast Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/27/2018
Start Date:March 2014
End Date:June 2016

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Increasing Adherence to Adjuvant Hormonal Therapy Among Breast Cancer Patients: Phase 2 - Pilot Test of Intervention for Feasibility

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.

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.

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
We found this trial at
4
sites
Burlington, Vermont 05401
Principal Investigator: Marie E. Wood
Phone: 802-847-3827
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Columbus, Ohio 43210
Principal Investigator: Douglas M. Post, PhD
Phone: 614-293-8007
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Columbus, OH
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Goldsboro, North Carolina 27534
Principal Investigator: James N. Atkins
Phone: 919-580-0000
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Goldsboro, NC
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Medical Center Boulevard
Winston-Salem, North Carolina 27157
336-716-2255
Principal Investigator: Susan A. Melin
Phone: 336-716-2839
Comprehensive Cancer Center of Wake Forest University Our newly expanded Comprehensive Cancer Center is the...
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Winston-Salem, NC
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