NCT03271099

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 16, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2020

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

2.9 years

First QC Date

August 31, 2017

Last Update Submit

September 7, 2021

Conditions

Cancer

Keywords

survivorship; navigation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Urgent/emergent care

    9 months

  • Cancer Needs Distress

    9 months

  • New Survivor Survey

    9 months

  • Lost to Care

    9 months

Study Arms (2)

Usual Care

NO INTERVENTION

Usual care

Navigator

EXPERIMENTAL

Patient navigator services provided as part of survivorship care plan

Other: Navigator

Interventions

NavigatorOTHER

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

Also known as: navigation
Navigator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Minh Tam Truong, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 1, 2017

Study Start

October 16, 2017

Primary Completion

September 10, 2020

Study Completion

September 10, 2020

Last Updated

September 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)