Breast CancerNCT01824745
Survivorship Care Planning in Improving the Quality of Life in Breast Cancer Survivors
A study testing educational intervention, counseling intervention and standard follow-up care in people with Breast Cancer and Cancer Survivor, run by City of Hope Medical Center at 2 sites in United States.
Trial summary
This randomized pilot clinical trial studies survivorship care planning in improving the quality of life in breast cancer survivors. Survivorship care planning may reduce stress and improve the well-being and quality of life of cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Cancer Survivor
- What is being tested?
- educational intervention, counseling intervention and standard follow-up care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Oct 2013to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- In early survivorship phase, defined as being post-surgery to ending of active treatment to 18 months post active treatment for stage 0-3 breast cancer (BCA)
- Reside in Southern California
- BCS treated at Kaiser, an health maintenance organization (HMO) provider, will be excluded since their SCP implementation project is underway
- BCS will not be excluded based on cancer treatments received or a history of diagnosis of mild depression, anxiety, and hypertension and diabetes
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope Medical Center
Duarte, California, 91010
City of Hope Antelope Valley
Lancaster, California, 93534
About this study
Official title: Survivorship Care Planning for At Risk Breast Cancer Survivors
This randomized pilot clinical trial studies survivorship care planning in improving the quality of life in breast cancer survivors. Survivorship care planning may reduce stress and improve the well-being and quality of life of cancer survivors.
Read the detailed description
PRIMARY OBJECTIVES:
- Test the effectiveness of the navigation intervention and survivorship care plan (SCP)-breast cancer survivors (BCS) template booklet on accessing and adhering to SCP-BCS guidelines compared to the control group receiving usual care and the SCP-BCS template booklet.
SECONDARY OBJECTIVES:
- Develop a clinically and psychosocially responsive SCP-breast cancer survivors (SCP-BCS) template in English and English-Spanish adopted from American Society of Clinical Oncology (ASCO)-SCP.
II. Assess the acceptability, utility and format preference (electronic vs paper) of the SCP-BCS template.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions.
ARM II: Participants receive SCP-BCS template booklet and receive standard follow-up care.
After completion so study treatment, participants are followed up at 6 and 12 months.
- Conditions
- Breast Cancer, Cancer Survivor
- Being tested
- educational intervention, counseling intervention, standard follow-up care, quality-of-life assessment, questionnaire administration
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
Also called intervention, educational
Receive the SCP-BCS template booklet
counseling interventionOther
Also called counseling and communications studies
Receive counseling sessions with a patient navigator
standard follow-up careProcedure or surgery
Receive standard follow-up care
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (SCP-BCS template booklet and counseling) | Experimental | Participants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions. Receives: Other: educational intervention; Other: counseling intervention; Procedure: quality-of-life assessment; Other: questionnaire administration |
| Arm II (SCP-BCS template booklet) | Active comparator | Participants receive SCP-BCS template booklet and receive standard follow-up care. Receives: Other: educational intervention; Procedure: standard follow-up care; Procedure: quality-of-life assessment; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of BCS accessing a SCP from their oncology provider
Fisher's exact test will be used to test the null hypothesis (at least 40% of trial participants will have access to SCP).
Measured: At 6 months
Secondary outcomes (2)
Adherence to SCP guidelines
Fisher's exact test will be used to test the null hypothesis (at least 25% of participants reporting adherence to SCP guidelines).
Measured: At 12 months
Proportion of BCS accessing a SCP from their oncology provider
Fisher's exact test will be used to test the null hypothesis (at least 60% of trial participants will have access to SCP).
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study start8 Oct 2013
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 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, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824745
- Sponsor's protocol ID
- 12383
- Other IDs
- NCI-2013-00734
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2013
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivorship Care Planning for At Risk Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01824745
- Acronym / sponsor ID
- 12383
- Conditions
- Breast Cancer, Cancer Survivor
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Oct 2013 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 5 Apr 2013 (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 randomized pilot clinical trial studies survivorship care planning in improving the quality of life in breast cancer survivors. Survivorship care planning may reduce stress and improve the well-being and quality of life of cancer survivors.
Detailed description
PRIMARY OBJECTIVES:
- Test the effectiveness of the navigation intervention and survivorship care plan (SCP)-breast cancer survivors (BCS) template booklet on accessing and adhering to SCP-BCS guidelines compared to the control group receiving usual care and the SCP-BCS template booklet.
SECONDARY OBJECTIVES:
- Develop a clinically and psychosocially responsive SCP-breast cancer survivors (SCP-BCS) template in English and English-Spanish adopted from American Society of Clinical Oncology (ASCO)-SCP.
II. Assess the acceptability, utility and format preference (electronic vs paper) of the SCP-BCS template.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions.
ARM II: Participants receive SCP-BCS template booklet and receive standard follow-up care.
After completion so study treatment, participants are followed up at 6 and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (SCP-BCS template booklet and counseling) | Experimental | Other: educational intervention, Other: counseling intervention, Procedure: quality-of-life assessment, Other: questionnaire administrationParticipants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions. |
| Arm II (SCP-BCS template booklet) | Active comparator | Other: educational intervention, Procedure: standard follow-up care, Procedure: quality-of-life assessment, Other: questionnaire administrationParticipants receive SCP-BCS template booklet and receive standard follow-up care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In early survivorship phase, defined as being post-surgery to ending of active treatment to 18 months post active treatment for stage 0-3 breast cancer (BCA)
- Reside in Southern California
- BCS treated at Kaiser, an health maintenance organization (HMO) provider, will be excluded since their SCP implementation project is underway
- BCS will not be excluded based on cancer treatments received or a history of diagnosis of mild depression, anxiety, and hypertension and diabetes
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| educational interventionAlso: intervention, educationalReceive the SCP-BCS template booklet | Other | Arm I (SCP-BCS template booklet and counseling), Arm II (SCP-BCS template booklet) |
| counseling interventionAlso: counseling and communications studiesReceive counseling sessions with a patient navigator | Other | Arm I (SCP-BCS template booklet and counseling) |
| standard follow-up careReceive standard follow-up care | Procedure or surgery | Arm II (SCP-BCS template booklet) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I (SCP-BCS template booklet and counseling), Arm II (SCP-BCS template booklet) |
| questionnaire administrationAncillary studies | Other | Arm I (SCP-BCS template booklet and counseling), Arm II (SCP-BCS template booklet) |
Primary outcome
Proportion of BCS accessing a SCP from their oncology provider
Time frame: At 6 months
Fisher's exact test will be used to test the null hypothesis (at least 40% of trial participants will have access to SCP).
2 secondary outcomes
Adherence to SCP guidelines
Time frame: At 12 months
Proportion of BCS accessing a SCP from their oncology provider
Time frame: At 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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 principal investigator
City of Hope Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention, counseling intervention and standard follow-up care in people with Breast Cancer and Cancer Survivor, run by City of Hope Medical Center at 2 sites 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 4 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 22 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 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of BCS accessing a SCP from their oncology provider (time frame: At 6 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 22 Oct 2026.