Patient Navigation in Cancer Survivorship at a Safety Net... | NCT03271099

Studies
Patient Navigation in Cancer Survivorship at a Safety Net Institution

NCT03271099

Sponsor

Boston Medical Center

Status

Completed

Last Update Posted

Sep 8, 2021Actual

Enrollment

39Actual

Phase

Not Applicable

Conditions

Cancer

Interventions

Navigator

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 16, 2017Actual

Primary Completion Date

Sep 10, 2020Actual

Completion Date

Sep 10, 2020Actual

First Submitted Date

Aug 31, 2017

First Submission Date that Met QC Criteria

Aug 31, 2017

First Posted Date

Sep 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2021

Last Update Posted Date

Sep 8, 2021Actual

Name	Class
Harvard Pilgrim Health Care	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Usual Care	No Intervention	Usual care
Navigator	Experimental	Patient navigator services provided as part of survivorship care plan	Other: Navigator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Navigator	Other	Patient Navigation services will be provided to try to eliminate barriers in pursuing survivorship surveillance	Navigator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
Cancer Needs Distress

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Minh Tam Truong, MD	Boston Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boston Medical Center		Boston	Massachusetts	02118	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided