Survivorship Care Planning in Improving the Quality of Life in Breast Cancer Survivors
NCT ID: NCT01824745
Last Updated: 2025-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
100 participants
INTERVENTIONAL
2013-07-15
2025-12-15
Brief Summary
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Detailed Description
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I. 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:
I. 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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Arm I (SCP-BCS template booklet and counseling)
Participants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions.
educational intervention
Receive the SCP-BCS template booklet
counseling intervention
Receive counseling sessions with a patient navigator
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
Arm II (SCP-BCS template booklet)
Participants receive SCP-BCS template booklet and receive standard follow-up care.
educational intervention
Receive the SCP-BCS template booklet
standard follow-up care
Receive standard follow-up care
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
Interventions
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educational intervention
Receive the SCP-BCS template booklet
counseling intervention
Receive counseling sessions with a patient navigator
standard follow-up care
Receive standard follow-up care
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Kimlin Ashing-Giwa
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
City of Hope Antelope Valley
Lancaster, California, United States
Countries
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Other Identifiers
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NCI-2013-00734
Identifier Type: REGISTRY
Identifier Source: secondary_id
12383
Identifier Type: -
Identifier Source: org_study_id
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