Patient Navigation in Cancer Survivorship at a Safety Net Institution

Study Overview
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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

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

Conditions
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Cancer

Intervention / Treatment
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* Other: Navigator


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Usual care | |
| Experimental: Navigator<br>Patient navigator services provided as part of survivorship care plan | Other: Navigator<br>* Patient Navigation services will be provided to try to eliminate barriers in pursuing survivorship surveillance<br>* Other names: navigation;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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survivorship; navigation