Breast Cancer(BC) SurvivorsNCT02514486
Assessment of Cancer Concerns at the End of Treatment (ACE)
An observational study of Breast Cancer(BC) Survivors, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
This study will describe patient-reported symptom burden and concerns, quality of life (QOL), and health behaviors of breast cancer(BC) survivors who have completed initial treatments (e.g., surgery, chemotherapy, and/or radiotherapy), assess the feasibility of using a web-based platform to collect patient-reported… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer(BC) Survivors
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 332 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 19 Jan 2018
- Phase
- Observational
- 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
Study population: Breast cancer survivors
Who may be able to join
- Diagnosed with invasive, non-metastatic BC (Stage I, II, or III) without hematogenous or distant metastases
- Have completed initial treatment (chemotherapy, radiotherapy, and/or surgery). May still be receiving hormonal or targeted therapy (e.g., tamoxifen, aromatase inhibitors).
- Within 1 year of completing primary treatment
- Scheduled for an EOT visit
- Age 18 years or older
- Can understand written English
- Have internet access and a working email address
Who cannot join
- Diagnosed with non-invasive (Stage 0/DCIS) or metastatic (Stage IV) cancer or hematogenous or distant metastatic disease
- No working email address -
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This study will describe patient-reported symptom burden and concerns, quality of life (QOL), and health behaviors of breast cancer(BC) survivors who have completed initial treatments (e.g., surgery, chemotherapy, and/or radiotherapy), assess the feasibility of using a web-based platform to collect patient-reported outcome (PRO) data, and evaluate provider satisfaction following delivery of an electronic health record (HER)/EPIC summary of these PROs. Secondary aims will estimate differences in referral to available services between those providers exposed to the PRO summary and historical controls. BC survivors who have completed initial treatment and present within the first year following treatment for an end of treatment (EOT)/survivorship focused visit will be the focus of this study.
- Conditions
- Breast Cancer(BC) Survivors
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of Questionnaire
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startJul 2014
- Primary completion19 Jan 2018
- Study completion19 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer(BC) SurvivorsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Jacobs, CRNP, PhD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514486
- Sponsor's protocol ID
- UPCC 13114
- Status last verified
- Dec 2019
- First submitted
- 31 Jul 2015
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cancer Concerns at the End of Treatment (ACE)
- ClinicalTrials.gov ID
- NCT02514486
- Acronym / sponsor ID
- UPCC 13114
- Conditions
- Breast Cancer(BC) Survivors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 19 Jan 2018 (actual)
- First posted
- 3 Aug 2015 (estimated)
- 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 study will describe patient-reported symptom burden and concerns, quality of life (QOL), and health behaviors of breast cancer(BC) survivors who have completed initial treatments (e.g., surgery, chemotherapy, and/or radiotherapy), assess the feasibility of using a web-based platform to collect patient-reported outcome (PRO) data, and evaluate provider satisfaction following delivery of an electronic health record (HER)/EPIC summary of these PROs. Secondary aims will estimate differences in referral to available services between those providers exposed to the PRO summary and historical controls. BC survivors who have completed initial treatment and present within the first year following treatment for an end of treatment (EOT)/survivorship focused visit will be the focus of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer survivors
Key inclusion criteria (7 listed)
- Diagnosed with invasive, non-metastatic BC (Stage I, II, or III) without hematogenous or distant metastases
- Have completed initial treatment (chemotherapy, radiotherapy, and/or surgery). May still be receiving hormonal or targeted therapy (e.g., tamoxifen, aromatase inhibitors).
- Within 1 year of completing primary treatment
- Scheduled for an EOT visit
- Age 18 years or older
Key exclusion criteria (2 listed)
- Diagnosed with non-invasive (Stage 0/DCIS) or metastatic (Stage IV) cancer or hematogenous or distant metastatic disease
- No working email address -
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 |
|---|---|---|
| Questionnaire | Behavioural | – |
Primary outcome
Completion of Questionnaire
Time frame: 2 years
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 3 Apr 2020.
Related trials for Breast Cancer(BC) Survivors
Recruiting
Personalized Exercise Program for Survivors of Breast Cancer, STEPS-BC Trial
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Not yet recruiting
AI-Based Symptom Management for Post-Treatment Breast Cancer Survivors
Breast Cancer, Cancer Survivorship
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.
Linda Jacobs, CRNP, PhD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer(BC) Survivors, 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 7 inclusion and 2 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 3 Apr 2020. 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?
Completion of Questionnaire (time frame: 2 years). 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 3 Apr 2020.