Recruiting

Hormone Therapy

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT07454499

Conditions

Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Digital Endocrine therapy Symptom Monitoring and Education Intervention

Study Details

Brief summary:

The purpose of the study is to learn more about ways to help patients understand and manage side-effects from hormone therapy. The investigators will use the information from this study to design future studies to better understand how our well our tools work to help patients monitor and manage symptoms from hormone therapy and to stay on their hormone therapy for the recommended period of time.

Conditions

Cancer

Study ID

NCT07454499

Start date

May 13, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must identify as a woman
  • Participants must be age 18 or older
  • Participants must have a diagnosis of Stage 0, I, II, or III HR+ breast cancer
  • Participants must have started initial treatment with standard of care oral endocrine therapy (ET) (i.e., tamoxifen, anastrozole, exemestane, or letrozole) within 16 weeks of study registration.
  • Participants must have completed surgery for treatment of breast cancer at least 14 days prior to randomization.
  • Participants who received chemotherapy must have finished it at least 14 days prior to randomization.
  • Speak and read in English
  • Own an internet-enabled cell phone
  • Capable of using the electronic pill bottle
  • Concomitant radiotherapy is allowed. Concomitant maintenance targeted or biologic therapy (e.g., anti-HER2 therapy, osteoclast inhibitor therapy, CDK 4/6 inhibitor, ovarian function suppression medications) is allowed.

Exclusion Criteria:

  • Metastatic (Stage IV) breast cancer
  • Male gender
  • Prior treatment with endocrine therapy for breast cancer
  • Communication difficulties such as: Uncorrected or uncompensated hearing and/or vision impairment, uncorrected or uncompensated speech defects, uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: ARM A Intervention

Patients assigned to symptom monitoring web-based intervention.

no intervention: ARM B Usual care

Participants will be provided with an educational handout describing endocrine therapy.

Interventions

Digital Endocrine therapy Symptom Monitoring and Education Intervention

Patients will receive text messages with links to symptom monitoring surveys and educational materials on possible symptoms from endocrine therapy.

Primary outcome measure

  • System Usability Scale (SUS) [ Time Frame: Once during study exit survey at 6 months ]
  • Feasibility- recruitment rates and intervention completion rates [ Time Frame: Consent to study exit survey at 6 months ]

Central Contacts and Locations

Central contacts

Kimberley Lee

215-615-1736kimberley.lee@pennmedicine.upenn.edu

Kelsey Karpink

215-662-3531kelsey.karpink@pennmedicine.upenn.edu

Locations

Abramson Cancer Center at the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Kimberley Lee, MD

kimberley.lee@pennmedicine.upenn.edu

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-06-12.