Breast Cancer, Cancer Survivor
Conditions
Brief 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.
Detailed description
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.
Interventions
OTHEReducational intervention
Receive the SCP-BCS template booklet
OTHERcounseling intervention
Receive counseling sessions with a patient navigator
PROCEDUREstandard follow-up care
Receive standard follow-up care
PROCEDUREquality-of-life assessment
Ancillary studies
OTHERquestionnaire administration
Ancillary studies
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of BCS accessing a SCP from their oncology provider | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to SCP guidelines | At 12 months | Fisher's exact test will be used to test the null hypothesis (at least 25% of participants reporting adherence to SCP guidelines). |
| Proportion of BCS accessing a SCP from their oncology provider | At 12 months | Fisher's exact test will be used to test the null hypothesis (at least 60% of trial participants will have access to SCP). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKimlin Ashing-Giwa
City of Hope Medical Center
Outcome results
None listed