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Clinical Trials/NCT03271099
NCT03271099
Completed
N/A

Patient Navigation as Part of the Cancer Survivorship Care Plan at a Safety Net Institution

Boston Medical Center1 site in 1 country39 target enrollmentOctober 16, 2017
ConditionsCancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cancer
Sponsor
Boston Medical Center
Enrollment
39
Locations
1
Primary Endpoint
Missed appointments
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

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

Registry
clinicaltrials.gov
Start Date
October 16, 2017
End Date
September 10, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Urgent/emergent care(9 months)
  • Cancer Needs Distress(9 months)
  • Lost to Care(9 months)
  • New Survivor Survey(9 months)

Study Sites (1)

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