Patient Navigation in Cancer Survivorship at a Safety Net Institution

NCT ID: NCT03271099

Last Updated: 2021-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-16

Study Completion Date

2020-09-10

Brief Summary

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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

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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

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Usual Care

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Navigator

Patient navigator services provided as part of survivorship care plan

Group Type EXPERIMENTAL

Navigator

Intervention Type OTHER

Patient Navigation services will be provided to try to eliminate barriers in pursuing survivorship surveillance

Interventions

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Navigator

Patient Navigation services will be provided to try to eliminate barriers in pursuing survivorship surveillance

Intervention Type OTHER

Other Intervention Names

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navigation

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harvard Pilgrim Health Care

OTHER

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minh Tam Truong, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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H-36781

Identifier Type: -

Identifier Source: org_study_id

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