39 Participants Needed

Telephone Support for Breast Cancer Treatment Adherence

Recruiting at 4 trial locations
OS
Overseen ByOhio State University Comprehensive Cancer Center
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Ohio State University Comprehensive Cancer Center
Must be taking: Adjuvant hormonal therapy
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on helping you stick to your prescribed adjuvant hormonal therapy for breast cancer.

Is telephone support for breast cancer treatment adherence safe?

The research indicates that while adjuvant hormone therapy (a type of treatment for breast cancer) can have side effects, these are generally related to adherence issues rather than safety concerns. No specific safety issues related to telephone support interventions were identified in the studies.12345

How is adjuvant hormonal therapy for breast cancer different from other treatments?

Adjuvant hormonal therapy for breast cancer is unique because it specifically targets hormone receptor-positive tumors, which are common in breast cancer, by blocking or lowering estrogen levels to prevent cancer growth. Unlike chemotherapy, which attacks all rapidly dividing cells, this therapy is more targeted and is taken orally over a long period to reduce recurrence and improve survival rates.46789

What data supports the effectiveness of the treatment Telephone Support for Breast Cancer Treatment Adherence?

Research shows that adherence to adjuvant endocrine therapy (AET) is crucial for reducing breast cancer recurrence and mortality, but many patients struggle to stick with the treatment. Strategies like improving patient-provider communication and providing frequent feedback have been suggested to enhance adherence, which could be supported by telephone-based interventions.4691011

Who Is on the Research Team?

MN

Michelle Naughton, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for post-menopausal women with stages I-III breast cancer who've finished primary treatment and are starting adjuvant hormonal therapy (AHT) like tamoxifen or aromatase inhibitors. Participants must own a smartphone, agree to text communication, consent to medical record review, and plan to stay in the study area for at least 3 months.

Inclusion Criteria

Plan to stay in the study area for 3 months
Provide consent and permission to review their medical records
Agree to receive text messages on their smartphone over a 3-month period
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily text messages reminding them to take AHT and weekly interactive surveys delivered by a smartphone app

3 months
Remote interactions via text and app

Follow-up

Participants are monitored for adherence and feedback on the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Adjuvant Hormonal Therapy
  • Telephone-Based Intervention
Trial Overview The study tests if regular phone calls can help patients stick to their hormone therapy schedule after breast cancer treatment. It involves surveys, lab biomarker analysis, and a telephone-based program designed to improve doctor-patient communication about medication adherence.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Supportive (text messages and interactive exchanges)Experimental Treatment3 Interventions
Patients receive daily text messages reminding them to take AHT and weekly interactive surveys delivered by a smart phone app for 3 months.

Adjuvant Hormonal Therapy is already approved in European Union, United States, Canada, Japan for the following indications:

πŸ‡ͺπŸ‡Ί
Approved in European Union as Hormone Therapy for:
  • Breast cancer
  • Prostate cancer
  • Endometrial cancer
πŸ‡ΊπŸ‡Έ
Approved in United States as Hormone Therapy for:
  • Breast cancer
  • Prostate cancer
  • Endometrial cancer
  • Uterine cancer
πŸ‡¨πŸ‡¦
Approved in Canada as Hormone Therapy for:
  • Breast cancer
  • Prostate cancer
  • Endometrial cancer
πŸ‡―πŸ‡΅
Approved in Japan as Hormone Therapy for:
  • Breast cancer
  • Prostate cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

Alliance for Clinical Trials in Oncology

Collaborator

Trials
521
Recruited
224,000+

Published Research Related to This Trial

A review of 363 studies identified only five that met the criteria for improving adherence to adjuvant endocrine therapy (AET) in hormone receptor-positive breast cancer survivors, indicating a significant gap in effective interventions.
Despite various interventions, including educational materials, none of the studies showed a significant improvement in adherence, highlighting the urgent need for tailored strategies led by clinicians to enhance treatment compliance and ultimately improve long-term survival.
Interventions to improve endocrine therapy adherence in breast cancer survivors: what is the evidence?Ekinci, E., Nathoo, S., Korattyil, T., et al.[2019]
The STRIDE intervention, a patient-centered videoconference program, aims to improve adherence to adjuvant endocrine therapy (AET) in breast cancer patients by addressing symptom management and reducing distress, with a feasibility trial involving 75 participants.
This study will objectively monitor medication adherence using electronic pill bottles and assess the intervention's impact on patient satisfaction and symptom distress over 24 weeks, providing valuable insights into effective support strategies for AET adherence.
Study protocol for a randomised controlled feasibility trial of a virtual intervention (STRIDE) for symptom management, distress and adherence to adjuvant endocrine therapy after breast cancer.Jacobs, JM., Rapoport, CS., Horenstein, A., et al.[2021]
In a survey of 939 breast cancer patients in Italy, 18.6% were found to be nonadherent to their adjuvant endocrine therapy, highlighting a significant issue that could affect survival outcomes.
Factors such as age, working status, and switching from tamoxifen to an aromatase inhibitor were identified as predictors of nonadherence, allowing for targeted interventions to improve adherence among high-risk subgroups.
Identification of subgroups of early breast cancer patients at high risk of nonadherence to adjuvant hormone therapy: results of an Italian survey.Tinari, N., Fanizza, C., Romero, M., et al.[2015]

Citations

Interventions to improve endocrine therapy adherence in breast cancer survivors: what is the evidence? [2019]
Study protocol for a randomised controlled feasibility trial of a virtual intervention (STRIDE) for symptom management, distress and adherence to adjuvant endocrine therapy after breast cancer. [2021]
Identification of subgroups of early breast cancer patients at high risk of nonadherence to adjuvant hormone therapy: results of an Italian survey. [2015]
Optimization of an Information Leaflet to Influence Medication Beliefs in Women With Breast Cancer: A Randomized Factorial Experiment. [2023]
Improving compliance and persistence to adjuvant tamoxifen and aromatase inhibitor therapy. [2022]
Assessing Adherence to Adjuvant Hormone Therapy in Breast Cancer Patients in Routine Clinical Practice. [2023]
Good adherence to adjuvant endocrine therapy in early breast cancer - a population-based study based on the Swedish Prescribed Drug Register. [2018]
Adherence to Adjuvant Endocrine Therapy in Breast Cancer Patients. [2023]
Traditional Korean medicine treatment for tamoxifen associated adverse events of breast cancer patient: A CARE - Compliant case report. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
A telehealth intervention for symptom management, distress, and adherence to adjuvant endocrine therapy: A randomized controlled trial. [2023]
Improving adherence to endocrine hormonal therapy among breast cancer patients: Study protocol for a randomized controlled trial. [2020]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceΒ·Privacy PolicyΒ·CookiesΒ·Security