Breast CancerNCT06246084
INTENT Pilot Study - Enhancing Adherence Intentions to Endocrine Therapy
A study testing Endocrine Therapy Education Program in people with Breast Cancer and Breast Cancer Female, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research is being done to pilot an intervention which aims to improve participants' experiences on Endocrine Therapy. The name of the intervention used in this research study is: Endocrine Therapy Education Program (a brief, video-based intervention) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Female, Breast Carcinoma
- What is being tested?
- Endocrine Therapy Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to 23 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Biologically female
- About to begin or just started (within four weeks of starting) an oral form of ET (either tamoxifen or AI)
- 18 years of age or older
- English fluency for reading and writing.
- Computer literacy (ability to watch videos and fill out questionnaires online)
Who cannot join
- Adults unable to consent
- Individuals with metastatic cancer
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
This research is being done to pilot an intervention which aims to improve participants' experiences on Endocrine Therapy.
The name of the intervention used in this research study is:
Endocrine Therapy Education Program (a brief, video-based intervention)
Read the detailed description
This research study is a randomized pilot study to determine whether a brief-video based intervention program can improve experiences of Endocrine Therapy (ET). Participants will be randomized into one of two groups: Group A: Endocrine Therapy Education Intervention vs. Group B Wait-list Control Group. Randomization means a participant is placed into a study group by chance.
The research study procedures include screening for eligibility, in-clinic visits, and survey questionnaires.
Participation in this research study is expected to last 3 months.
It is expected that about 60 people will take part in this research study.
- Conditions
- Breast Cancer, Breast Cancer Female, Breast Carcinoma
- Being tested
- Endocrine Therapy Education Program
- Keywords
- Breast Cancer, Breast Cancer Female, Breast Carcinoma
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocrine Therapy Education ProgramBehavioural
Brief, video-based intervention program to improve endocrine therapy adherence and experiences and to provide detailed education to participants. The intervention is distributed and assessed via the MyEmma platform, a HIPAA-compliant, online communications platform.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Endocrine Therapy Education Intervention | Experimental | Participants will complete:
* Baseline visit.
* Educational video once a week for 6 weeks.
* 6-week survey.
* 3-month survey. Receives: Behavioral: Endocrine Therapy Education Program |
| Group B: Wait-List Control Group | No intervention | Participants will complete: * Baseline visit. * 6-week survey. * 3-month survey. * Access to intervention educational videos. * 2-week post video survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement Rate of Intervention
Adequate engagement of the intervention is defined as a click-to-open rate of 60% or over for the intervention group.
Measured: 6 weeks
Intervention Satisfaction Questionnaire Mean Score Group A
Responses will be analyzed to determine a mean score for each item for the intervention group. The Intervention Satisfaction Questionnaire includes 9 items rated on a 1 to 10 scale.
Measured: At 6 weeks
Intervention Satisfaction Questionnaire Mean Score Group B
Responses will be analyzed to determine a mean score for each item for the control group (following the release of the intervention educational videos). The Intervention Satisfaction Questionnaire includes 9 items rated on a 1 to 10 scale.
Measured: At 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start15 Feb 2024
- Primary completion31 Jul 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Ann Partridge, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246084
- Sponsor's protocol ID
- 23-607
- Status last verified
- Sep 2024
- First submitted
- 30 Jan 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTENT Pilot Study - Enhancing Adherence Intentions to Endocrine Therapy
- ClinicalTrials.gov ID
- NCT06246084
- Acronym / sponsor ID
- 23-607
- Conditions
- Breast Cancer, Breast Cancer Female, Breast Carcinoma
- Keywords
- Breast Cancer, Breast Cancer Female, Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 7 Feb 2024 (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.
This research is being done to pilot an intervention which aims to improve participants' experiences on Endocrine Therapy.
The name of the intervention used in this research study is:
Endocrine Therapy Education Program (a brief, video-based intervention)
Detailed description
This research study is a randomized pilot study to determine whether a brief-video based intervention program can improve experiences of Endocrine Therapy (ET). Participants will be randomized into one of two groups: Group A: Endocrine Therapy Education Intervention vs. Group B Wait-list Control Group. Randomization means a participant is placed into a study group by chance.
The research study procedures include screening for eligibility, in-clinic visits, and survey questionnaires.
Participation in this research study is expected to last 3 months.
It is expected that about 60 people will take part in this research study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Endocrine Therapy Education Intervention | Experimental | Behavioral: Endocrine Therapy Education ProgramParticipants will complete: * Baseline visit. * Educational video once a week for 6 weeks. * 6-week survey. * 3-month survey. |
| Group B: Wait-List Control Group | No intervention | –Participants will complete: * Baseline visit. * 6-week survey. * 3-month survey. * Access to intervention educational videos. * 2-week post video survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Biologically female
- About to begin or just started (within four weeks of starting) an oral form of ET (either tamoxifen or AI)
- 18 years of age or older
- English fluency for reading and writing.
- Computer literacy (ability to watch videos and fill out questionnaires online)
Key exclusion criteria (5 listed)
- Adults unable to consent
- Individuals with metastatic cancer
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
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 |
|---|---|---|
| Endocrine Therapy Education ProgramBrief, video-based intervention program to improve endocrine therapy adherence and experiences and to provide detailed education to participants. The intervention is distributed and assessed via the MyEmma platform, a HIPAA-compliant, online communications platform. | Behavioural | Group A: Endocrine Therapy Education Intervention |
Primary outcome
Engagement Rate of Intervention
Time frame: 6 weeks
Adequate engagement of the intervention is defined as a click-to-open rate of 60% or over for the intervention group.
Intervention Satisfaction Questionnaire Mean Score Group A
Time frame: At 6 weeks
Responses will be analyzed to determine a mean score for each item for the intervention group. The Intervention Satisfaction Questionnaire includes 9 items rated on a 1 to 10 scale.
Intervention Satisfaction Questionnaire Mean Score Group B
Time frame: At 14 weeks
Responses will be analyzed to determine a mean score for each item for the control group (following the release of the intervention educational videos). The Intervention Satisfaction Questionnaire includes 9 items rated on a 1 to 10 scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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. This study is not recruiting at the moment.
Ann Partridge, MD, MPH principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endocrine Therapy Education Program in people with Breast Cancer and Breast Cancer Female, run by Dana-Farber Cancer Institute 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 22 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement Rate of Intervention (time frame: 6 weeks). The study lists 3 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 22 Jan 2025.