Cancer Clinical Trial
Official title:
Patient Navigation as Part of the Cancer Survivorship Care Plan at a Safety Net Institution
Verified date | September 2021 |
Source | Boston Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study seeks to enroll patients receiving a Survivorship Care Plan following curative therapy for cancer. Participants will be randomly assigned to receive usual care or to be followed by a Patient Navigator as part of their Survivorship Care Plan.
Status | Completed |
Enrollment | 39 |
Est. completion date | September 10, 2020 |
Est. primary completion date | September 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Stage I, II, III or IVa Cancer diagnosis (may include Solitary plasmacytoma, Diffuse Large B-Cell Lymphoma (DLBCL), ductal carcinoma in situ (DCIS) of the breast) - Completed treatment with curative intent within the past 12 months. (May be on maintenance therapy.) Exclusion Criteria: - Distant Metastatic disease - Non-curable disease - Recurrence of disease prior to enrollment - Require ongoing navigation from the treatment navigator - Enrolled/active in another randomized study (Project SUPPORT) |
Country | Name | City | State |
---|---|---|---|
United States | Boston Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Medical Center | Harvard Pilgrim Health Care |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Missed appointments | The research team will document the number of cancer care appointments scheduled and of those, how many appointments were missed (obtained by medical record and by patient report in case a visit was outside of study institution). | 9 months | |
Secondary | Urgent/emergent care | The research team will document the number of urgent/emergent care visits attended within the study period of 9 months (obtained by medical record and by patient report in case a visit was outside of study institution). | 9 months | |
Secondary | Cancer Needs Distress | Participants will rate their feelings about 39 specific cancer needs on a 5 point scale from "Not a Problem" to "Very Severe Problem" using the Cancer Needs Distress Inventory (CaNDI) tool. Total scores can range from 39 to 195. Lower scores are associated with less cancer related distress. | 9 months | |
Secondary | New Survivor Survey | Participants will rate their understanding about 16 specific aspects of survivorship care on a 4 point scale from "Strongly Disagree" to "Strongly Agree" using the Preparing for Life as a New Survivor (PLANS) Scale. Total scores can range from 16 to 48. Lower scores are associated with less understanding of the survivorship care process. | 9 months | |
Secondary | Lost to Care | The research team will document the number of participants lost to care, based on consecutive missed cancer care visits. | 9 months |
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