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Patient Navigation in Cancer Survivorship at a Safety Net Institution

Sponsor
Boston Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03271099
Collaborator
Harvard Pilgrim Health Care (Other)
39
Enrollment
1
Location
2
Arms
34.8
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Navigator
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Patient Navigation as Part of the Cancer Survivorship Care Plan at a Safety Net Institution
Actual Study Start Date :
Oct 16, 2017
Actual Primary Completion Date :
Sep 10, 2020
Actual Study Completion Date :
Sep 10, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    2. 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.

    3. 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.

    4. Lost to Care [9 months]

      The research team will document the number of participants lost to care, based on consecutive missed cancer care visits.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boston Medical Center Boston Massachusetts United States 02118

    Sponsors and Collaborators

    • Boston Medical Center
    • Harvard Pilgrim Health Care

    Investigators

    • Principal Investigator: Minh Tam Truong, MD, Boston Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Boston Medical Center
    ClinicalTrials.gov Identifier:
    NCT03271099
    Other Study ID Numbers:
    • H-36781
    First Posted:
    Sep 1, 2017
    Last Update Posted:
    Sep 8, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Boston Medical Center
    survivorship; navigation

    Study Results

    No Results Posted as of Sep 8, 2021