Breast CancerNCT05700396
Breast Cancer Survivor Educational Intervention
A study testing Breast Cancer Survivor Education Program in people with Breast Cancer and Breast Neoplasms, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this study is to test a 6-week virtual education program among Black breast cancer survivors. The virtual program includes sessions on physical activity, goal setting, nutrition, sleep, stress, and social connections. Read more about this study
- Who is it for?
- Ages 22 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Breast Carcinoma
- What is being tested?
- Breast Cancer Survivor Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2023to 31 Dec 2023
- 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 22 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Self-identified Black or African American race
- Age 22-79
- Diagnosis of Stage I, II, or III invasive breast cancer
- Completed active treatment at least 6 months ago, but within the past five years
- Speaks English
Who cannot join
- Undergoing active treatment (i.e., surgery, chemotherapy, radiation)
- Undergoing evaluation for suspected recurrence
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215
About this study
Official title: Increasing Receipt of Guideline Concordant Survivorship Care Among Black Breast Cancer Survivors Through Patient Education
The goal of this study is to test a 6-week virtual education program among Black breast cancer survivors. The virtual program includes sessions on physical activity, goal setting, nutrition, sleep, stress, and social connections.
Read the detailed description
This six-week feasibility study will evaluate a virtual support and education program among up to 15 Black female breast cancer survivors. Participants will be asked to attend a 90 minute group session once a week for 6 weeks and complete surveys pre and post intervention surveys to ascertain study endpoints. This study is supported by funding from Pfizer and in-kind support from the American Cancer Society, Inc.
- Being tested
- Breast Cancer Survivor Education Program
- Keywords
- Breast Cancer, Breast Neoplasms, Breast Carcinoma, Breast Cancer Female, Breast cancer survivor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Cancer Survivor Education ProgramBehavioural
Weekly sessions via Zoom platform with study staff.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Survivor Education Program | Experimental | Participants will complete study procedures as outlined:
- 6 weekly sessions of a modified version of the PAVING the Path to Wellness education program. Receives: Behavioral: Breast Cancer Survivor Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Retention Rate
Defined as the number of recruited participants who initiate intervention program.
Measured: 6 weeks
Time Required to Recruit to Target
Defined as the amount of time to target accrual goal.
Measured: 6 weeks
Proportion of Eligible Participants
Defined as the number of eligible participants required to recruit required sample size.
Measured: 6 weeks
Rate of Intervention Completion
Defined as the number of participants who attend at least 5 of 6 sessions.
Measured: 6 weeks
Success Rate of Educational Intervention
Proportion of participants "very satisfied" or "completely satisfied" with intervention. Defined successful if true of 80% of participants.
Measured: 6 weeks
Data collection feasibility
Proportion of participants completing evaluation surveys each at baseline and week 6.
Measured: 6 weeks
Secondary outcomes (5)
Self-Efficacy for symptom self-management
Self-Efficacy for symptom self-management will be assessed using Symptom-Management Self-Efficacy Scale-Breast Cancer
Measured: 6 weeks
Intention to Receive post-treatment Surveillance Mammography
Intention to Receive post-treatment Surveillance Mammography will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey
Measured: 6 weeks
Physical Activity Goal Change
Physical Activity Goal Change will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey
Measured: 6 weeks
Dietary Behavior Goal Change
Dietary Behavior Goal Change will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey
Measured: 6 weeks
Unmet information Needs
Unmet information Needs will be assessed using Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS) Survey
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start28 Feb 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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 Massachusetts General HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., Pfizer
- Responsible party
- Principal investigator, Erica T. Warner, ScD MPH, Massachusetts General Hospital
- Investigators
- Erica Warner, MPH, ScD, Principal investigator, Massachusetts General HospitalAmy Comander, MD, Study director, Massachusetts General HospitalNaomi Ko, MD, Study director, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700396
- Sponsor's protocol ID
- 22-509
- Status last verified
- Mar 2025
- First submitted
- 17 Jan 2023
- Last updated
- 1 Apr 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Receipt of Guideline Concordant Survivorship Care Among Black Breast Cancer Survivors Through Patient Education
- ClinicalTrials.gov ID
- NCT05700396
- Acronym / sponsor ID
- 22-509
- Keywords
- Breast Cancer, Breast Neoplasms, Breast Carcinoma, Breast Cancer Female, Breast cancer survivor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., Pfizer
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Jan 2023 (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 goal of this study is to test a 6-week virtual education program among Black breast cancer survivors. The virtual program includes sessions on physical activity, goal setting, nutrition, sleep, stress, and social connections.
Detailed description
This six-week feasibility study will evaluate a virtual support and education program among up to 15 Black female breast cancer survivors. Participants will be asked to attend a 90 minute group session once a week for 6 weeks and complete surveys pre and post intervention surveys to ascertain study endpoints. This study is supported by funding from Pfizer and in-kind support from the American Cancer Society, Inc.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Survivor Education Program | Experimental | Behavioral: Breast Cancer Survivor Education ProgramParticipants will complete study procedures as outlined: - 6 weekly sessions of a modified version of the PAVING the Path to Wellness education program. |
Who may qualify
- Ages
- 22 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female
- Self-identified Black or African American race
- Age 22-79
- Diagnosis of Stage I, II, or III invasive breast cancer
- Completed active treatment at least 6 months ago, but within the past five years
Key exclusion criteria (2 listed)
- Undergoing active treatment (i.e., surgery, chemotherapy, radiation)
- Undergoing evaluation for suspected recurrence
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 |
|---|---|---|
| Breast Cancer Survivor Education ProgramWeekly sessions via Zoom platform with study staff. | Behavioural | Breast Cancer Survivor Education Program |
Primary outcome
Recruitment Retention Rate
Time frame: 6 weeks
Defined as the number of recruited participants who initiate intervention program.
Time Required to Recruit to Target
Time frame: 6 weeks
Defined as the amount of time to target accrual goal.
Proportion of Eligible Participants
Time frame: 6 weeks
Defined as the number of eligible participants required to recruit required sample size.
Rate of Intervention Completion
Time frame: 6 weeks
Defined as the number of participants who attend at least 5 of 6 sessions.
Success Rate of Educational Intervention
Time frame: 6 weeks
Proportion of participants "very satisfied" or "completely satisfied" with intervention. Defined successful if true of 80% of participants.
Data collection feasibility
Time frame: 6 weeks
Proportion of participants completing evaluation surveys each at baseline and week 6.
5 secondary outcomes
Self-Efficacy for symptom self-management
Time frame: 6 weeks
Intention to Receive post-treatment Surveillance Mammography
Time frame: 6 weeks
Physical Activity Goal Change
Time frame: 6 weeks
Dietary Behavior Goal Change
Time frame: 6 weeks
Unmet information Needs
Time frame: 6 weeks
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 1 Apr 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.
Erica Warner, MPH, ScD principal investigator
Massachusetts General Hospital
Amy Comander, MD study director
Massachusetts General Hospital
Naomi Ko, MD study director
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Cancer Survivor Education Program in people with Breast Cancer and Breast Neoplasms, run by Massachusetts General Hospital 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 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 1 Apr 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?
Recruitment Retention Rate (time frame: 6 weeks). The study lists 6 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 1 Apr 2025.