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OpenTrials
Completed

NCT Number: NCT03271099

Patient Navigation in Cancer Survivorship 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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

navigator

Other

Patient Navigation services will be provided to try to eliminate barriers in pursuing survivorship surveillance

Other names: navigation

Primary outcomes

  1. Missed appointments

    Time frame: 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 outcomes

  1. Urgent/emergent care

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 9 months

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

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Harvard Pilgrim Health Care

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 1, 2017
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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