Breast CancerNCT00932997
Survivorship Booklets With or Without Individual Telephone Sessions in Increasing Knowledge About the Impact of Breast Cancer in African American and Latina Breast Cancer Survivors
A study testing telephone-based intervention, counseling intervention and educational intervention in people with Breast Cancer and Cancer Survivor, run by City of Hope Medical Center at 1 site in United States.
Trial summary
RATIONALE: Telephone sessions and survivorship booklets may increase knowledge about the psychological and physical impact of breast cancer and increase awareness of available resources. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer, Cancer Survivor, Psychosocial Effects of Cancer and Its Treatment
- What is being tested?
- telephone-based intervention, counseling intervention and educational intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2004to 1 Jun 2010
- 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 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosed with breast cancer within the past 1-5 years
- Stage I-IIIA disease
- No metastatic disease
PATIENT CHARACTERISTICS:
- No other major disabling medical (e.g., another cancer, stroke, heart disease) or psychiatric conditions
- Self-identified ethnically as African-American or Latina
- Able to read and/or speak English or Spanish
- No severe depression or anxiety
- History of mild to moderate depression or anxiety allowed
- Not pregnant
- Not incarcerated
PRIOR CONCURRENT THERAPY:
- Any type of prior anticancer therapy allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
About this study
Official title: Reducing the Burden of Breast Cancer Among African American and Latina Survivors
RATIONALE: Telephone sessions and survivorship booklets may increase knowledge about the psychological and physical impact of breast cancer and increase awareness of available resources. It is not yet known whether survivorship booklets are more effective when given alone or together with individual telephone sessions in informing breast cancer survivors.
PURPOSE: This randomized clinical trial is studying individual telephone sessions given together with survivorship booklets compared with survivorship booklets alone to see how well they work in increasing knowledge about the impact of breast cancer in African American and Latina breast cancer survivors.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the utility of individual telephone sessions plus survivorship booklets versus the survivorship booklets alone in increasing knowledge about the psychological and physical impact of breast cancer and increasing awareness of appropriate psychological and medical resources among African American and Latina breast cancer survivors.
- Evaluate the utility of these interventions in improving psychological functioning (depression and anxiety) among breast cancer survivors.
- Evaluate the utility of these interventions in improving family and social functioning (changes in family and partner communications) among breast cancer survivors.
Secondary
- Evaluate predictors of health-related quality of life (demographic, medical care factors, psychological, socio-ecological, and socio-cultural factors) within and across breast cancer survivors ethnic groups to identify both general and ethnic-specific correlates.
OUTLINE: Patients are stratified according to ethnicity (African American vs Latina). Patients are randomized to 1 of 2 groups.
- Group 1: Patients receive a survivorship kit of booklets in English or Spanish. Patients then receive a follow-up telephone call at approximately 2 months to clarify any issues relevant to the survivorship kit of booklets.
- Group 2: Patients participate in 8 weekly telephone sessions addressing basic breast cancer information; education about psychological and medical effects of cancer and its treatments; resources including psychosocial, medical care facilities, and clinical trials information; stress management and relaxation; cognitive reframing of concerns and behavioral strategies; family communication; relational communication and intimacy; and social support. Patients also receive a survivorship kit of booklets as in group 1.
After completion of study intervention, patients complete follow-up questionnaires at 4 to 6 months.
- Being tested
- telephone-based intervention, counseling intervention, educational intervention, questionnaire administration, psychosocial assessment and care
- Keywords
- psychosocial effects of cancer and its treatment, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, 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.
telephone-based interventionBehavioural
Participants receive a "Survivorship Kit" and telephone sessions based upon responses to initial survey
counseling interventionOther
Participants receive a "Survivorship Kit" and telephone sessions based upon responses to initial survey
educational interventionOther
Participants receive a "Survivorship Kit" alone or in combination with telephone sessions based upon responses to initial survey
questionnaire administrationOther
Baseline and 9 months after enrollment and intervention
psychosocial assessment and careProcedure or surgery
Participants receive a "Survivorship Kit" alone or in combination with telephone sessions based upon responses to initial survey
quality-of-life assessmentProcedure or surgery
Baseline and 9 months after enrollment and intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased knowledge about the psychological and physical impact of breast cancer
Measured: 9 months post study enrollment
Improved psychological functioning (depression and anxiety)
Measured: 9 months post study enrollment
Improved family and social functioning (changes in family and partner communications)
Measured: 9 months post study enrollment
Secondary outcomes (1)
Predictors of health-related quality of life (demographic, medical care factors, psychological, socio-ecological, and socio-cultural factors)
Measured: 9 months post study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study start8 May 2004
- Primary completion1 Jun 2010
- Study completion1 Jun 2010
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 City of Hope Medical CenterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kimlin Ashing-Giwa, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932997
- Sponsor's protocol ID
- 06102
- Other IDs
- P30CA033572, CHNMC-06102, CDR0000642414
- Status last verified
- Sep 2026
- First submitted
- 3 Jul 2009
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Burden of Breast Cancer Among African American and Latina Survivors
- ClinicalTrials.gov ID
- NCT00932997
- Acronym / sponsor ID
- 06102
- Keywords
- psychosocial effects of cancer and its treatment, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, cancer survivor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 May 2004 (actual)
- Primary completion
- 1 Jun 2010 (actual)
- Study completion
- 1 Jun 2010 (actual)
- First posted
- 7 Jul 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.
RATIONALE: Telephone sessions and survivorship booklets may increase knowledge about the psychological and physical impact of breast cancer and increase awareness of available resources. It is not yet known whether survivorship booklets are more effective when given alone or together with individual telephone sessions in informing breast cancer survivors.
PURPOSE: This randomized clinical trial is studying individual telephone sessions given together with survivorship booklets compared with survivorship booklets alone to see how well they work in increasing knowledge about the impact of breast cancer in African American and Latina breast cancer survivors.
Detailed description
OBJECTIVES:
Primary
- Evaluate the utility of individual telephone sessions plus survivorship booklets versus the survivorship booklets alone in increasing knowledge about the psychological and physical impact of breast cancer and increasing awareness of appropriate psychological and medical resources among African American and Latina breast cancer survivors.
- Evaluate the utility of these interventions in improving psychological functioning (depression and anxiety) among breast cancer survivors.
- Evaluate the utility of these interventions in improving family and social functioning (changes in family and partner communications) among breast cancer survivors.
Secondary
- Evaluate predictors of health-related quality of life (demographic, medical care factors, psychological, socio-ecological, and socio-cultural factors) within and across breast cancer survivors ethnic groups to identify both general and ethnic-specific correlates.
OUTLINE: Patients are stratified according to ethnicity (African American vs Latina). Patients are randomized to 1 of 2 groups.
- Group 1: Patients receive a survivorship kit of booklets in English or Spanish. Patients then receive a follow-up telephone call at approximately 2 months to clarify any issues relevant to the survivorship kit of booklets.
- Group 2: Patients participate in 8 weekly telephone sessions addressing basic breast cancer information; education about psychological and medical effects of cancer and its treatments; resources including psychosocial, medical care facilities, and clinical trials information; stress management and relaxation; cognitive reframing of concerns and behavioral strategies; family communication; relational communication and intimacy; and social support. Patients also receive a survivorship kit of booklets as in group 1.
After completion of study intervention, patients complete follow-up questionnaires at 4 to 6 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| telephone-based interventionParticipants receive a "Survivorship Kit" and telephone sessions based upon responses to initial survey | Behavioural | – |
| counseling interventionParticipants receive a "Survivorship Kit" and telephone sessions based upon responses to initial survey | Other | – |
| educational interventionParticipants receive a "Survivorship Kit" alone or in combination with telephone sessions based upon responses to initial survey | Other | – |
| questionnaire administrationBaseline and 9 months after enrollment and intervention | Other | – |
| psychosocial assessment and careParticipants receive a "Survivorship Kit" alone or in combination with telephone sessions based upon responses to initial survey | Procedure or surgery | – |
| quality-of-life assessmentBaseline and 9 months after enrollment and intervention | Procedure or surgery | – |
Primary outcome
Increased knowledge about the psychological and physical impact of breast cancer
Time frame: 9 months post study enrollment
Improved psychological functioning (depression and anxiety)
Time frame: 9 months post study enrollment
Improved family and social functioning (changes in family and partner communications)
Time frame: 9 months post study enrollment
1 secondary outcome
Predictors of health-related quality of life (demographic, medical care factors, psychological, socio-ecological, and socio-cultural factors)
Time frame: 9 months post study enrollment
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 Oct 2026.
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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.
Kimlin Ashing-Giwa, PhD principal investigator
City of Hope 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 telephone-based intervention, counseling intervention and educational intervention in people with Breast Cancer and Cancer Survivor, run by City of Hope Medical Center 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?
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 Oct 2026. 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?
Increased knowledge about the psychological and physical impact of breast cancer (time frame: 9 months post study enrollment). 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 1 Oct 2026.