The Effectiveness of Patient Navigation in Cancer Care

Rationale: Supportive care such as physical therapy, psycho-social education, and dietary advice is likely to have a positive effect on the recovery and quality of life of cancer patients. Currently, not all patients know how to access supportive care, which results in unmet supportive care needs. This study determines whether these unmet needs can be reduced or prevented by a patient navigation intervention that focuses on timely screening and systematic monitoring of patient's supportive care needs.

Objective: The primary objective is to determine the effect of patient navigation on health related quality of life. Secondary objectives are: 1) to determine the effect of patient navigation on satisfaction with, need for, and consumption of (supportive) cancer care; 2) to determine the effect of patient navigation on patients' self-management; 3) to explore how patient navigation affects the cost-effectiveness of cancer care.

Study design: Longitudinal randomised controlled trial with two study arms: a patient navigation intervention and care as usual.

Study population: Newly diagnosed lung, melanoma, urology, or gynecology patients of the Netherlands Cancer Institute.

Intervention : Consultations with a specifically trained oncology nurse (i.e. patient navigator), who assesses patients' needs for supportive cancer care, provides information on supportive cancer care, and guides patients through the supportive cancer care system. Consultations with the patient navigator take place at the start, halfway through, and at the end of treatment.

Main study endpoints: The main endpoint of this study is health related quality of life, which is defined as an individual's perceived emotional, social, physical, and functional wellbeing over time. Health related quality of life is assessed with the EORTC QLQ-C30.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants are expected to strongly benefit from consulting the patient navigator without being subjected to any severe risks. Consultations will be provided by highly qualified professionals, and result in benefits such as decreased severity of cancer-related psychosocial and physical distress. To minimise burden, face-to-face consultations will always be scheduled alongside other appointments of at the NKI-AVL. Furthermore, questionnaire completion takes no more than 30 minutes per data collection round, of which three are scheduled in this study.

Study Overview

• Status: Unknown
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Patient navigation

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1066 CX
      • Dutch Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed with lung, melanoma, urology or gynecology related cancer
• Male or female
• Treated at the Dutch Cancer Institute
• Has not started treatment at the Dutch Cancer Institute
• 18 years of age and over
• Curative or palliative treatment
• Able to understands and speak Dutch

Exclusion Criteria:

• Not willing to sign the consent form
• Not willing to meet with the patient navigator
• Not willing to complete questionnaires at any point in time

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Care as usual
Experimental: Patient navigation	Behavioral: Patient navigation; Consultations with a specifically trained oncology nurse (i.e. patient navigator), who assesses patients' needs for supportive cancer care, provides information on supportive cancer care, and guides patients through the supportive cancer care system. Consultations with the patient navigator take place at the start, halfway through, and at the end of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in health related quality of life	EORTC QLQ-C30	Baseline, month 1, month 3, month 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in need for supportive cancer care	Distress Thermometer	Baseline, month 1, month 3, month 5
Satisfaction with (supportive) cancer care	(Adapted version of) Patient Satisfaction with Cancer Care	Month 5
Change in consumption of supportive cancer care	(Adapted version of) Medical Consumption Questionnaire	Baseline, month 1, month 3, month 5
Change in self-management	Study specific questions on knowledge and self-efficacy	Baseline, month 1, month 3, month 5
Change in work productivity	Study specific questions on work productivity	Baseline and month 5
Change in health status	EQ-5D-5L	Baseline and month 5

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Investigators: Study Director: Eveline Bleiker, PhD, The Netherlands Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2016
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: September 25, 2017
• First Submitted That Met QC Criteria: October 9, 2017
• First Posted (Actual): October 10, 2017

Study Record Updates

• Last Update Posted (Actual): October 10, 2017
• Last Update Submitted That Met QC Criteria: October 9, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: N16NVG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No