- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03271099
Patient Navigation in Cancer Survivorship at a Safety Net Institution
Patient Navigation as Part of the Cancer Survivorship Care Plan at a Safety Net Institution
Study Overview
Detailed Description
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.
Study participation for all participants will be for up to 9 months, with study visits approximately every 3 months, based on standard clinical follow-up. All participants will be administered quality of life surveys by a Clinical Research Associate at study entry, mid-study (approximately 3-6 months) and at study completion.
The following factors will be compared between arms:
- Missed/kept appointments
- Use of urgent/emergent care
- Quality of Life in relation to survivorship care
- Participants lost to care
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Boston Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care
Usual care
|
|
Experimental: Navigator
Patient navigator services provided as part of survivorship care plan
|
Patient Navigation services will be provided to try to eliminate barriers in pursuing survivorship surveillance
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Missed appointments
Time Frame: 9 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urgent/emergent care
Time Frame: 9 months
|
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
|
Cancer Needs Distress
Time Frame: 9 months
|
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
|
New Survivor Survey
Time Frame: 9 months
|
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
|
Lost to Care
Time Frame: 9 months
|
The research team will document the number of participants lost to care, based on consecutive missed cancer care visits.
|
9 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Minh Tam Truong, MD, Boston Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H-36781
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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