Telephone Support for Breast Cancer Treatment Adherence

No longer recruiting at 4 trial locations

Overseen By Ohio 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

Disqualifiers: Premenopausal, No smartphone, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a phone-based program can help women with breast cancer adhere to their hormone therapy medications (also known as adjuvant hormonal therapy). By enhancing communication between patients and doctors through daily text reminders and weekly interactive surveys, the trial seeks to determine if this support improves adherence to the treatment plan. Women who are post-menopausal, diagnosed with stages I-III breast cancer, and starting hormone therapy for the first time may qualify if they own a smartphone. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance treatment adherence and patient support.

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.

What prior data suggests that this telephone-based intervention is safe for increasing treatment adherence?

Research has shown that adjuvant hormonal therapy is generally safe for treating breast cancer, though it can cause side effects. Some studies have found that many women stop this therapy early due to these side effects, which can increase the risk of cancer returning. However, the therapy effectively reduces the chance of breast cancer recurrence over time.

Common side effects include hot flashes, joint pain, and tiredness, which can vary in severity from person to person. Despite these issues, adjuvant hormonal therapy remains an important part of treatment for many, as it helps lower the risk of cancer returning.

Adjuvant hormonal therapy has been widely used and studied, providing a good understanding of its risks. While monitoring for side effects is important, many patients generally tolerate this therapy well. Patients should always discuss any concerns with a doctor to understand the benefits and risks for their specific health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the telephone support intervention for breast cancer treatment adherence because it offers a novel way to enhance patient engagement and medication compliance. Unlike traditional methods where patients receive occasional reminders from healthcare providers, this approach uses daily text messages and interactive surveys via a smartphone app to keep patients on track with their adjuvant hormonal therapy. This method not only provides consistent reminders but also encourages active participation, potentially leading to improved adherence and better treatment outcomes.

What evidence suggests that this telephone-based intervention is effective for increasing adherence to breast cancer treatment?

Research has shown that additional hormone therapy can reduce the chance of breast cancer returning by 40-50% in women with early-stage estrogen receptor-positive breast cancer. However, many patients struggle to continue the therapy. Studies reveal that 31-73% of women stop their medication before the recommended five years. In this trial, participants will receive daily text messages reminding them to take their medication and weekly interactive surveys via a smartphone app for three months. Previous studies have tested similar methods. One study found that text message reminders aimed to improve adherence, while another found that a remote monitoring app with text messages did not significantly help patients stay on track in the first year. These findings suggest that while the therapy is effective, new methods to support patient adherence are still under exploration. ^{6 7 8 9 10}

Who Is on the Research Team?

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

Provide consent and permission to review their medical records

Plan to stay in the study area for 3 months

Agree to receive text messages on their smartphone over a 3-month period

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?

Group I: Supportive (text messages and interactive exchanges) Experimental Treatment 3 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:

Approved in European Union as Hormone Therapy for:

• Breast cancer
• Prostate cancer
• Endometrial cancer

Approved in United States as Hormone Therapy for:

• Breast cancer
• Prostate cancer
• Endometrial cancer
• Uterine cancer

Approved in Canada as Hormone Therapy for:

• Breast cancer
• Prostate cancer
• Endometrial cancer

Approved in Japan as Hormone Therapy for:

• Breast cancer
• Prostate cancer

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

In a study of 118 patients with hormone receptor-positive breast cancer, the adherence rate to adjuvant hormone therapy was found to be 81% over two years, indicating a significant level of compliance despite the known benefits of treatment for overall survival.

Older patients (mean age 65) were more likely to adhere to hormone therapy compared to younger patients (mean age 60), suggesting that age may play a role in treatment adherence, which is crucial for maximizing the benefits of therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Adherence to Adjuvant Hormone Therapy in Breast Cancer Patients in Routine Clinical Practice. Camejo, N., Castillo, C., Tambasco, C., et al.[2023]

In a study of 634 primary breast cancer patients in Region Jönköping County, Sweden, 91.2% adhered to adjuvant endocrine therapy after 3 years, and 91.5% after 5 years, indicating high treatment compliance.

The study suggests that adherence rates are significantly higher than previously reported, potentially due to effective therapy information and follow-up routines, although further investigation is needed to confirm this.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Good adherence to adjuvant endocrine therapy in early breast cancer - a population-based study based on the Swedish Prescribed Drug Register. Lundgren, C., Lindman, H., Rolander, B., et al.[2018]

The STRIDE telehealth intervention was feasible and well-accepted by 100 breast cancer patients on adjuvant endocrine therapy, with 70.9% enrollment and 86% completing at least 4 out of 6 sessions.

Patients in the STRIDE group reported significantly less symptom distress and improved self-management, coping, quality of life, and mood compared to those in the medication monitoring control group, indicating STRIDE's potential to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A telehealth intervention for symptom management, distress, and adherence to adjuvant endocrine therapy: A randomized controlled trial. Jacobs, JM., Post, K., Massad, K., et al.[2023]

Adjuvant endocrine hormonal therapy (EHT) is crucial for nearly all breast cancer patients with hormone receptor-positive tumors, significantly reducing recurrence rates and the risk of death, yet about 33% of patients do not adhere to their prescribed medication.

This study aims to improve adherence to EHT through a bilingual, culturally tailored smartphone app and support from a patient navigator, with the goal of enhancing patient education, self-management, and ultimately improving survival and quality of life for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving adherence to endocrine hormonal therapy among breast cancer patients: Study protocol for a randomized controlled trial. Chalela, P., Munoz, E., Inupakutika, D., et al.[2020]

A significant 81% of breast cancer patients reported side effects from adjuvant endocrine therapy (AET), with tamoxifen users experiencing hot flashes (55.6%) and aromatase inhibitor users suffering from arthralgia (60.6%).

12% of patients discontinued AET due to these side effects, highlighting the need for better patient-physician communication and support systems to improve adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Adjuvant Endocrine Therapy in Breast Cancer Patients. Rosso, R., D'Alonzo, M., Bounous, VE., et al.[2023]

An optimized information leaflet intervention, designed using a factorial experiment with 1,604 healthy women, effectively improved beliefs about the necessity of adjuvant endocrine therapy (AET) by incorporating patient input and diagrams about AET mechanisms.

The study found that including enhanced information about AET benefits and addressing concerns was beneficial, while detailed side effect information was excluded from the final leaflet, suggesting that less emphasis on side effects may improve adherence to AET.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of an Information Leaflet to Influence Medication Beliefs in Women With Breast Cancer: A Randomized Factorial Experiment. Green, SMC., Hall, LH., French, DP., et al.[2023]

A 50-year-old breast cancer patient experienced significant adverse effects from tamoxifen, including hot flushes, hyperhidrosis, urinary frequency, and depression, which negatively impacted her quality of life.

After 25 days of treatment with traditional Korean herbal medicine and acupuncture, the patient's symptoms improved significantly, indicating that these interventions may help alleviate tamoxifen-induced side effects in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traditional Korean medicine treatment for tamoxifen associated adverse events of breast cancer patient: A CARE - Compliant case report. Seo, J., Lee, D., Jo, HG.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to improve endocrine therapy adherence in breast cancer survivors: what is the evidence? Ekinci, E., Nathoo, S., Korattyil, T., et al.[2019]

Compliance with adjuvant endocrine therapy for breast cancer is generally high in clinical trials, but real-world data shows a significant drop in persistence after 12 months, with declines of up to 50% in ongoing therapy.

Strategies to improve adherence include enhancing healthcare access, managing side effects, providing patient education, and fostering strong communication between patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving compliance and persistence to adjuvant tamoxifen and aromatase inhibitor therapy. Hadji, P.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10409554/

Assessing Adherence to Adjuvant Hormone Therapy in Breast ... A lack of adherence to adjuvant endocrine therapy is common, 31.0-73.0% of women discontinue endocrine treatment before 5 years.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02400060

Telephone-Based Intervention in Increasing Adherence to ... This pilot trial studies a telephone-based intervention to see if it increases adherence to adjuvant hormonal therapy in patients with breast cancer.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1462388925002509

Supporting women with adherence to adjuvant endocrine ... In women with early-stage ER+ve disease, adjuvant endocrine therapy (AET) reduces risk of breast cancer recurrence by 40-50% which, in turn, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6862779/

Increasing Adherence to Adjuvant Hormone Therapy ... This study tested the feasibility and efficacy of using a text-based intervention to increase initiation, decrease discontinuation, and improve adherence

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820436

Remote Monitoring App for Endocrine Therapy Adherence ... In this randomized clinical trial of 304 women, a remote monitoring app combined with text messages did not improve AET adherence in the first year.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11880597/

Side-effects in women treated with adjuvant endocrine ... Many women with breast cancer prematurely discontinue adjuvant endocrine therapy, leading to increased mortality.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0960977625005387

The effects of adjuvant endocrine therapy on long-term ... In summary, the use of adjuvant ET reduced the risk of recurrence in patients with DCIS. However, further research is needed to identify specific DCIS subgroups ...

8. esmoopen.com esmoopen.com/article/S2059-7029(25)00926-3/fulltext

Extended adjuvant endocrine therapy in early breast cancer 10 years of adjuvant ET is superior to 5 years in reducing recurrences. Seven to eight years of ET improves outcomes compared with 5 years.

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2839036

Adjuvant Radiation and Endocrine Therapy in Early-Stage ... Our results show that a variety of adjuvant therapy options are associated with acceptably low LRR, and younger patients with low genomic risk ...

10. nejm.org nejm.org/doi/full/10.1056/NEJMoa1701830

20-Year Risks of Breast-Cancer Recurrence after Stopping ... After 5 years of adjuvant endocrine therapy, breast-cancer recurrences continued to occur steadily throughout the study period from 5 to 20 years.