Breast CancerNCT02366806
Impact of Individualized Radiotherapy Plan Review in Patients Receiving Adjuvant Radiotherapy for Breast Cancer
An observational study of Breast Cancer, run by University of California, Davis at 1 site in United States.
Trial summary
This study is being conducted to investigate the effect of a more in-depth education plan for patients with breast cancer. Patients will be randomized to receive either the standard education plan during their breast cancer treatment or they will receive in-depth education about their breast cancer treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 7 Apr 2017
- 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study is for women with breast cancer. All patients will be staged according to the American Joint Committee on Cancer Seventh edition. Primary disease treatment information including surgical approach and utilization of adjuvant chemotherapy will be evaluated.
Who may be able to join
- Diagnosis of invasive breast cancer
- AJCC stage 1, 2, 3 breast carcinoma
- Patient deemed clinically appropriate for adjuvant breast or chest wall radiation following surgery
- Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
- Patient must provide study specific informed consent prior to study entry
- Breast implants allowed
Who cannot join
- Stage 4 breast cancer
- Ductal carcinoma in situ
- Patients treated with radiation for palliative intent
- Prior treatment with radiation therapy to the ipsilateral breast or chest wall
- Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry
- Prior invasive or in-situ carcinoma of the breast (-prior LCIS is eligible)
- Diagnosis of DCIS
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
This study is being conducted to investigate the effect of a more in-depth education plan for patients with breast cancer. Patients will be randomized to receive either the standard education plan during their breast cancer treatment or they will receive in-depth education about their breast cancer treatment. In order to see what kind of effect the different education plans have, patients will fill out three identical questionnaires during the course of treatment.
Read the detailed description
This study will be a prospective study of women receiving adjuvant radiation therapy for management of breast cancer at the University of California Davis. All patients will be staged according to the American Joint Committee on Cancer Seventh edition. Primary disease treatment information including surgical approach and utilization of adjuvant chemotherapy will be evaluated.
All patients will have a validated quality of life assessment (FACIT-TS-PS) completed at three time points during their radiation therapy process. The patients will be randomized at the time of completion of radiation plan approval by the treating radiation oncologist in a one to one fashion to either proceed with standard education or more extensive plan review. The radiation oncology quality assurance (QA) process will be blinded to the randomization of the patient.
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, AJCC Stage 1, 2, 3, Educational Design, Radiation Therapy Treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| In-Depth Education | A. Standard radiotherapy discussion including rationale, number of fractions, side effects, +/- beam arrangements, potential and likely short and long-term toxicity, status checks, skin care, nursing and physician accessibility B. Radiotherapy plan review to include, but not limited to: beam arrangement, total dose, dose per fraction, target area(s), description of isodose lines, DVH review and discussion of prescription constraints for OARs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction measure
Questions on the survey will be analyzed to see if patients are more satisfied with the in-depth education compared to the standard education.
Measured: 3 months
Secondary outcomes (2)
Time measure
The amount of time in the clinic office will be analyzed for the in-depth education plan as compared to the standard education plan.
Measured: 3 Months
Change in satisfaction over time
Questions on the survey will be analyzed from baseline to the end of treatment to see if there are differences over time between the in-depth education group and the standard education group.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startApr 2014
- Primary completion7 Apr 2017
- Study completion7 Apr 2017
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 University of California, DavisThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Daly, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366806
- Sponsor's protocol ID
- 587842
- Other IDs
- CCRO035
- Status last verified
- Oct 2020
- First submitted
- 6 Feb 2015
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Individualized Radiotherapy Plan Review in Patients Receiving Adjuvant Radiotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT02366806
- Acronym / sponsor ID
- 587842
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, AJCC Stage 1, 2, 3, Educational Design, Radiation Therapy Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- 7 Apr 2017 (actual)
- Study completion
- 7 Apr 2017 (actual)
- First posted
- 19 Feb 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 is being conducted to investigate the effect of a more in-depth education plan for patients with breast cancer. Patients will be randomized to receive either the standard education plan during their breast cancer treatment or they will receive in-depth education about their breast cancer treatment. In order to see what kind of effect the different education plans have, patients will fill out three identical questionnaires during the course of treatment.
Detailed description
This study will be a prospective study of women receiving adjuvant radiation therapy for management of breast cancer at the University of California Davis. All patients will be staged according to the American Joint Committee on Cancer Seventh edition. Primary disease treatment information including surgical approach and utilization of adjuvant chemotherapy will be evaluated.
All patients will have a validated quality of life assessment (FACIT-TS-PS) completed at three time points during their radiation therapy process. The patients will be randomized at the time of completion of radiation plan approval by the treating radiation oncologist in a one to one fashion to either proceed with standard education or more extensive plan review. The radiation oncology quality assurance (QA) process will be blinded to the randomization of the patient.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In-Depth Education | – | –A. Standard radiotherapy discussion including rationale, number of fractions, side effects, +/- beam arrangements, potential and likely short and long-term toxicity, status checks, skin care, nursing and physician accessibility B. Radiotherapy plan review to include, but not limited to: beam arrangement, total dose, dose per fraction, target area(s), description of isodose lines, DVH review and discussion of prescription constraints for OARs |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is for women with breast cancer. All patients will be staged according to the American Joint Committee on Cancer Seventh edition. Primary disease treatment information including surgical approach and utilization of adjuvant chemotherapy will be evaluated.
Key inclusion criteria (6 listed)
- Diagnosis of invasive breast cancer
- AJCC stage 1, 2, 3 breast carcinoma
- Patient deemed clinically appropriate for adjuvant breast or chest wall radiation following surgery
- Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
- Patient must provide study specific informed consent prior to study entry
Key exclusion criteria (7 listed)
- Stage 4 breast cancer
- Ductal carcinoma in situ
- Patients treated with radiation for palliative intent
- Prior treatment with radiation therapy to the ipsilateral breast or chest wall
- Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Satisfaction measure
Time frame: 3 months
Questions on the survey will be analyzed to see if patients are more satisfied with the in-depth education compared to the standard education.
2 secondary outcomes
Time measure
Time frame: 3 Months
Change in satisfaction over time
Time frame: 3 months
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 28 Oct 2020.
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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.
Megan Daly, MD principal investigator
UC Davis
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, run by University of California, Davis 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 6 inclusion and 7 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 28 Oct 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?
Satisfaction measure (time frame: 3 months). 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 28 Oct 2020.