Patient Navigation in Cancer Survivorship at a Safety Net Institution

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: Navigator

• Registration Number: NCT03271099
• Lead Sponsor: Boston Medical Center

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

Study Timeline

• Study First Submitted: 2017-08-31
• Study First Submitted QC: 2017-08-31
• Study First Posted: 2017-09-01
• Study Start: 2017-10-16
• Primary Completion: 2020-09-10
• Study Completion: 2020-09-10
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Navigator	Navigator	Patient navigator services provided as part of survivorship care plan

Primary Outcome Measures

Name	Time	Method
Missed appointments	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 Outcome Measures

Name	Time	Method
Urgent/emergent care	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).
Cancer Needs Distress	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.
Lost to Care	9 months	The research team will document the number of participants lost to care, based on consecutive missed cancer care visits.
New Survivor Survey	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.

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States