Breast CancerNCT00929084
Survivor Stories: Impact on Cancer Patients' Quality of Life and Follow-up
A study testing The Survivor Stories Tablet in people with Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to evaluate in a randomized controlled trail, an innovative cancer communication strategy to help African American breast cancer patients cope with a variety of challenges during and after treatment and to better adhere to recommended treatment guidelines and follow-up care. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- The Survivor Stories Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2016
- 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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American women
- First primary ductal carcinoma in situ (DCIS) or stages I, II, or III invasive breast cancer.
Who cannot join
- Prior DCIS or breast cancer diagnosis
- Stage IV or metastatic breast cancer
- Planned to receive a double mastectomy
- non-English speaking,
- Having known psychiatric or neurologic disorders
- Being cognitively impaired according to weighted error scores on the Orientation-Memory-Concentration Test
- Being unwilling or unable to give consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The purpose of this study is to evaluate in a randomized controlled trail, an innovative cancer communication strategy to help African American breast cancer patients cope with a variety of challenges during and after treatment and to better adhere to recommended treatment guidelines and follow-up care.
Read the detailed description
Disparities in incidence and mortality between African Americans and Caucasians for a number of cancers have been well documented. This study builds on previous work in St. Louis to overcome barriers to access to breast screening, identifying and addressing factors associated with access to care once diagnosed, and factors contributing to delay in diagnosis and completion of therapy. African American breast cancer patients randomly assigned to the intervention arm of the trial will have access to the Survivor Stories Tablet, a tablet computer, on which they will browse an archive of 1-3 minute videotaped survivor stories about five topics: coping, relationships, experiences with the health care system, follow-up care, and quality of life (QOL) living with breast cancer. Patients will have the tablet for two weeks after enrollment in the study, and again at 6 and 12 months. Patients in the control arm will receive usual care.
- Conditions
- Breast Cancer
- Being tested
- The Survivor Stories Tablet
- Keywords
- Race Disparities, Breast Cancer, Quality of Life, Treatment Adherence
- Medical subject headings
- Breast Neoplasms, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Survivor Stories TabletOther
The Survivor Stories Tablet is a tablet computer where participants can browse an archive of 1-3 minute videotaped survivor stories told by African American Breast Cancer Survivors. Stories contain five main topics: coping, relationships, experiences with the health care system, follow-up care, and quality of life (QOL) living with breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| Survivor Stories Arm | Other | Women in the Survivor Stories intervention arm will be given the Survivor Stories Tablet to take home for two weeks at three different time points over a two year period. Receives: Other: The Survivor Stories Tablet |
| Control Arm | Other | Women in the Control Arm will receive standard care. Receives: Other: The Survivor Stories Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine to what extent African American breast cancer survivor stories affect various aspects of QOL, including depressed mood and concern about recurrence, among African American breast cancer patients following primary treatment.
Measured: Outcome measures are assessed at five time points: baseline, one month following primary treatment surgery, 6 months, one year, and two years post surgery.
Secondary outcomes (1)
Determine whether and to what extent African American breast cancer survivor stories affect African American breast cancer patients' adherence to recommended surveillance mammography and prescribed hormone therapy
Measured: Outcome measures are assessed at five time points: baseline, one month following primary treatment surgery, 6 months, one year, and two years post surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startNov 2009
- Primary completionJan 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donna Jeffe, Washington University School of Medicine
- Investigators
- Donna B Jeffe, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929084
- Sponsor's protocol ID
- 000799
- Status last verified
- Feb 2025
- First submitted
- 24 Jun 2009
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thompson T, Perez M, Kreuter M, Margenthaler J, Colditz G, Jeffe DB. Perceived social support in African American breast cancer patients: Predictors and effects. Soc Sci Med. 2017 Nov;192:134-142. doi: 10.1016/j.socscimed.2017.09.035. Epub 2017 Sep 22.
PubMed 28965004Thompson T, Perez M, Yan Y, Kreuter MW, Margenthaler JA, Colditz GA, Jeffe DB. Randomized controlled trial of a breast cancer Survivor Stories intervention for African American women. Soc Sci Med. 2021 Feb;270:113663. doi: 10.1016/j.socscimed.2020.113663. Epub 2020 Dec 29.
PubMed 33454539Perez M, Kreuter MW, Yan Y, Thompson T, Sefko J, Golla B, Margenthaler JA, Colditz G, Jeffe DB. Feasibility and Acceptability of an Interactive Cancer-Communication Video Program Using African American Breast Cancer Survivor Stories. J Health Commun. 2020 Jul 2;25(7):566-575. doi: 10.1080/10810730.2020.1821132. Epub 2020 Oct 13.
PubMed 33048635Jarvandi S, Perez M, Margenthaler J, Colditz GA, Kreuter MW, Jeffe DB. Improving Lifestyle Behaviors After Breast Cancer Treatment Among African American Women With and Without Diabetes: Role of Health Care Professionals. Ann Behav Med. 2021 Feb 12;55(1):1-13. doi: 10.1093/abm/kaaa020.
PubMed 32298407Schootman M, Perez M, Schootman JC, Fu Q, McVay A, Margenthaler J, Colditz GA, Kreuter MW, Jeffe DB. Influence of built environment on quality of life changes in African-American patients with non-metastatic breast cancer. Health Place. 2020 May;63:102333. doi: 10.1016/j.healthplace.2020.102333. Epub 2020 May 11.
PubMed 32543424Cho B, Perez M, Jeffe DB, Kreuter MW, Margenthaler JA, Colditz GA, Liu Y. Factors associated with initiation and continuation of endocrine therapy in women with hormone receptor-positive breast cancer. BMC Cancer. 2022 Aug 1;22(1):837. doi: 10.1186/s12885-022-09946-x.
PubMed 35915419
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivor Stories: Impact on Cancer Patients' Quality of Life and Follow-up
- ClinicalTrials.gov ID
- NCT00929084
- Acronym / sponsor ID
- 000799
- Conditions
- Breast Cancer
- Keywords
- Race Disparities, Breast Cancer, Quality of Life, Treatment Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jan 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Jun 2009 (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.
The purpose of this study is to evaluate in a randomized controlled trail, an innovative cancer communication strategy to help African American breast cancer patients cope with a variety of challenges during and after treatment and to better adhere to recommended treatment guidelines and follow-up care.
Detailed description
Disparities in incidence and mortality between African Americans and Caucasians for a number of cancers have been well documented. This study builds on previous work in St. Louis to overcome barriers to access to breast screening, identifying and addressing factors associated with access to care once diagnosed, and factors contributing to delay in diagnosis and completion of therapy. African American breast cancer patients randomly assigned to the intervention arm of the trial will have access to the Survivor Stories Tablet, a tablet computer, on which they will browse an archive of 1-3 minute videotaped survivor stories about five topics: coping, relationships, experiences with the health care system, follow-up care, and quality of life (QOL) living with breast cancer. Patients will have the tablet for two weeks after enrollment in the study, and again at 6 and 12 months. Patients in the control arm will receive usual care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivor Stories Arm | Other | Other: The Survivor Stories TabletWomen in the Survivor Stories intervention arm will be given the Survivor Stories Tablet to take home for two weeks at three different time points over a two year period. |
| Control Arm | Other | Other: The Survivor Stories TabletWomen in the Control Arm will receive standard care. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- African American women
- First primary ductal carcinoma in situ (DCIS) or stages I, II, or III invasive breast cancer.
Key exclusion criteria (7 listed)
- Prior DCIS or breast cancer diagnosis
- Stage IV or metastatic breast cancer
- Planned to receive a double mastectomy
- non-English speaking,
- Having known psychiatric or neurologic disorders
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 |
|---|---|---|
| The Survivor Stories TabletThe Survivor Stories Tablet is a tablet computer where participants can browse an archive of 1-3 minute videotaped survivor stories told by African American Breast Cancer Survivors. Stories contain five main topics: coping, relationships, experiences with the health care system, follow-up care, and quality of life (QOL) living with breast cancer. | Other | Control Arm, Survivor Stories Arm |
Primary outcome
Determine to what extent African American breast cancer survivor stories affect various aspects of QOL, including depressed mood and concern about recurrence, among African American breast cancer patients following primary treatment.
Time frame: Outcome measures are assessed at five time points: baseline, one month following primary treatment surgery, 6 months, one year, and two years post surgery.
1 secondary outcome
Determine whether and to what extent African American breast cancer survivor stories affect African American breast cancer patients' adherence to recommended surveillance mammography and prescribed hormone therapy
Time frame: Outcome measures are assessed at five time points: baseline, one month following primary treatment surgery, 6 months, one year, and two years post surgery.
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 6 Feb 2025.
- Results publication: PubMed 28965004Thompson T, Perez M, Kreuter M, Margenthaler J, Colditz G, Jeffe DB. Perceived social support in African American breast cancer patients: Predictors and effects. Soc Sci Med. 2017 Nov;192:134-142. doi: 10.1016/j.socscimed.2017.09.035. Epub 2017 Sep 22.
- Results publication: PubMed 33454539Thompson T, Perez M, Yan Y, Kreuter MW, Margenthaler JA, Colditz GA, Jeffe DB. Randomized controlled trial of a breast cancer Survivor Stories intervention for African American women. Soc Sci Med. 2021 Feb;270:113663. doi: 10.1016/j.socscimed.2020.113663. Epub 2020 Dec 29.
- Results publication: PubMed 33048635Perez M, Kreuter MW, Yan Y, Thompson T, Sefko J, Golla B, Margenthaler JA, Colditz G, Jeffe DB. Feasibility and Acceptability of an Interactive Cancer-Communication Video Program Using African American Breast Cancer Survivor Stories. J Health Commun. 2020 Jul 2;25(7):566-575. doi: 10.1080/10810730.2020.1821132. Epub 2020 Oct 13.
- Results publication: PubMed 32298407Jarvandi S, Perez M, Margenthaler J, Colditz GA, Kreuter MW, Jeffe DB. Improving Lifestyle Behaviors After Breast Cancer Treatment Among African American Women With and Without Diabetes: Role of Health Care Professionals. Ann Behav Med. 2021 Feb 12;55(1):1-13. doi: 10.1093/abm/kaaa020.
- Results publication: PubMed 32543424Schootman M, Perez M, Schootman JC, Fu Q, McVay A, Margenthaler J, Colditz GA, Kreuter MW, Jeffe DB. Influence of built environment on quality of life changes in African-American patients with non-metastatic breast cancer. Health Place. 2020 May;63:102333. doi: 10.1016/j.healthplace.2020.102333. Epub 2020 May 11.
- Derived from this study: PubMed 35915419Cho B, Perez M, Jeffe DB, Kreuter MW, Margenthaler JA, Colditz GA, Liu Y. Factors associated with initiation and continuation of endocrine therapy in women with hormone receptor-positive breast cancer. BMC Cancer. 2022 Aug 1;22(1):837. doi: 10.1186/s12885-022-09946-x.
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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.
Donna B Jeffe, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Survivor Stories Tablet in people with Breast Cancer, run by Washington University School of 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 2 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 6 Feb 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?
Determine to what extent African American breast cancer survivor stories affect various aspects of QOL, including depressed mood and concern about recurrence, among African American breast cancer patients following primary treatment. (time frame: Outcome measures are assessed at five time points: baseline, one month following primary treatment surgery, 6 months, one year, and two years post surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00929084, which also lists 6 linked publications.
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 6 Feb 2025.