The Effectiveness of Patient Navigation in Cancer Care

NCT03305965 | Unknown

• 1 other identifier: N16NVG
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Change in health related quality of life

  EORTC QLQ-C30

  Baseline, month 1, month 3, month 5

Secondary Outcomes (6)

• Change in need for supportive cancer care

  Baseline, month 1, month 3, month 5

• Satisfaction with (supportive) cancer care

  Month 5

• Change in consumption of supportive cancer care

  Baseline, month 1, month 3, month 5

• Change in self-management

  Baseline, month 1, month 3, month 5

• Change in work productivity

  Baseline and month 5

Study Arms (2)

Patient navigation

EXPERIMENTAL

Behavioral: Patient navigation

Care as usual

NO INTERVENTION

Interventions

Patient navigation BEHAVIORAL

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.

Patient navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age and over
• Curative or palliative treatment
• Able to understands and speak Dutch

You may not qualify if:

• 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

Dutch Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Patient Navigation

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Eveline Bleiker, PhD

  The Netherlands Cancer Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient navigation vs. care as usual

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 10, 2017
• Study Start: October 15, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 10, 2017

Record last verified: 2017-10

Locations

NL (1)