CancerNCT07454499
Engaging M-health for Symptom Monitoring and Health Promotion for Women on Endocrine Therapy for Breast Cancer (EmSHAPE)
A study testing Digital Endocrine therapy Symptom Monitoring and Education Intervention in people with Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer
- What is being tested?
- Digital Endocrine therapy Symptom Monitoring and Education Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Kimberley Lee, MD, kimberley.lee@pennmedicine.upenn.edu
About this study
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.
Read the detailed description
Despite robust available data supporting the efficacy of oral endocrine therapy (ET) for the treatment of breast cancer and the low adherence to this life-saving treatment, only 6 randomized controlled trials have assessed interventions to improve adherence to ET; only 1 showed modest short-term benefit. ET adherence is critical, as 10-year survival decreases from 81% when adherent to 74% when non-adherent to ET. The investigators propose a first of its kind, randomized, culturally tailored mHealth intervention trial called "EmSHAPE"- Engaging mobile health for symptom monitoring and health promotion for endocrine therapy - among newly diagnosed women with early hormone receptor positive breast cancer. Prior intervention studies have not been effective.
- Conditions
- Cancer
- Being tested
- Digital Endocrine therapy Symptom Monitoring and Education Intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Endocrine therapy Symptom Monitoring and Education InterventionBehavioural
Patients will receive text messages with links to symptom monitoring surveys and educational materials on possible symptoms from endocrine therapy.
| Study group | Role | What they receive |
|---|---|---|
| ARM A Intervention | Experimental | Patients assigned to symptom monitoring web-based intervention. Receives: Behavioral: Digital Endocrine therapy Symptom Monitoring and Education Intervention |
| ARM B Usual care | No intervention | Participants will be provided with an educational handout describing endocrine therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale (SUS)
Determined via patient reported satisfaction with the intervention; final score from 0-100 (higher score represents better usability)
Measured: Once during study exit survey at 6 months
Feasibility- recruitment rates and intervention completion rates
Evaluated via rates of recruitment and intervention completion
Measured: Consent to study exit survey at 6 months
Secondary outcomes (2)
Endocrine therapy adherence
Proportion of days participant takes medication
Measured: Day 1 though study completion, an average of 48 weeks
FACTS-ES likert variables
Side effects of endocrine therapy
Measured: Assessed at baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start13 May 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Fox Chase Cancer Center, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kimberley Lee, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454499
- Sponsor's protocol ID
- UPCC 24124
- Other IDs
- IRB# 856525, K08CA279076
- Status last verified
- Jun 2026
- First submitted
- 21 Jan 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging M-health for Symptom Monitoring and Health Promotion for Women on Endocrine Therapy for Breast Cancer (EmSHAPE)
- ClinicalTrials.gov ID
- NCT07454499
- Acronym / sponsor ID
- UPCC 24124
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Fox Chase Cancer Center, National Cancer Institute (NCI)
- Study start
- 13 May 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite robust available data supporting the efficacy of oral endocrine therapy (ET) for the treatment of breast cancer and the low adherence to this life-saving treatment, only 6 randomized controlled trials have assessed interventions to improve adherence to ET; only 1 showed modest short-term benefit. ET adherence is critical, as 10-year survival decreases from 81% when adherent to 74% when non-adherent to ET. The investigators propose a first of its kind, randomized, culturally tailored mHealth intervention trial called "EmSHAPE"- Engaging mobile health for symptom monitoring and health promotion for endocrine therapy - among newly diagnosed women with early hormone receptor positive breast cancer. Prior intervention studies have not been effective.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A Intervention | Experimental | Behavioral: Digital Endocrine therapy Symptom Monitoring and Education InterventionPatients assigned to symptom monitoring web-based intervention. |
| ARM B Usual care | No intervention | –Participants will be provided with an educational handout describing endocrine therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Endocrine therapy Symptom Monitoring and Education InterventionPatients will receive text messages with links to symptom monitoring surveys and educational materials on possible symptoms from endocrine therapy. | Behavioural | ARM A Intervention |
Primary outcome
System Usability Scale (SUS)
Time frame: Once during study exit survey at 6 months
Determined via patient reported satisfaction with the intervention; final score from 0-100 (higher score represents better usability)
Feasibility- recruitment rates and intervention completion rates
Time frame: Consent to study exit survey at 6 months
Evaluated via rates of recruitment and intervention completion
2 secondary outcomes
Endocrine therapy adherence
Time frame: Day 1 though study completion, an average of 48 weeks
FACTS-ES likert variables
Time frame: Assessed at baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kimberley Lee, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Endocrine therapy Symptom Monitoring and Education Intervention in people with Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberley Lee (215-615-1736, kimberley.lee@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (SUS) (time frame: Once during study exit survey at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.