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

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 Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Navigator

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: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

2

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	Other: Navigator; Patient Navigation services will be provided to try to eliminate barriers in pursuing survivorship surveillance; Other Names: navigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	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	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	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: Boston Medical Center
• Collaborators: Harvard Pilgrim Health Care
• Investigators: Principal Investigator: Minh Tam Truong, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): September 10, 2020
• Study Completion (Actual): September 10, 2020

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: survivorship; navigation
• Other Study ID Numbers: H-36781

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No