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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00734 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Arm II (SCP-BCS template booklet) | Active Comparator | Participants receive SCP-BCS template booklet and receive standard follow-up care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| educational intervention | Other | Receive the SCP-BCS template booklet |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At 12 months |
| Proportion of BCS accessing a SCP from their oncology provider |
| Measure | Description | Time Frame |
|---|---|---|
| Develop a clinically and psychosocially responsive SCP-BCS template in English and a linguistically response bilingual version (English-Spanish) | The acceptability, utility, and format preference will also be assessed. A rating score will be generated for acceptability and utility and 95% confidence intervals for the proportion of BCS rating score at >= 4 will be assessed. | Up to 12 months |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimlin Ashing-Giwa | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States | ||
| City of Hope Antelope Valley |
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| counseling intervention | Other | Receive counseling sessions with a patient navigator |
|
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| standard follow-up care | Procedure | Receive standard follow-up care |
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| quality-of-life assessment | Procedure | Ancillary studies |
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| questionnaire administration | Other | Ancillary studies |
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Fisher's exact test will be used to test the null hypothesis (at least 60% of trial participants will have access to SCP).
| At 12 months |
| Lancaster |
| California |
| 93534 |
| United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D008722 | Methods |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D008919 | Investigative Techniques |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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