Patient Navigation in Cancer Survivorship at a Safety Net Institution

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03271099
• Other study ID #: H-36781
• Status: Completed
• Phase: N/A
• Start date: October 16, 2017
• Est. completion date: September 10, 2020

Study information

• Verified date: September 2021
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 10, 2020
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Harvard Pilgrim Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Lost to Care	The research team will document the number of participants lost to care, based on consecutive missed cancer care visits.	9 months