The Effectiveness of Patient Navigation in Cancer Care

Cancer Clinical Trial

Official title:

The Effectiveness of Patient Navigation in Cancer Care

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03305965
• Other study ID #: N16NVG
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 25, 2017
• Last updated: October 9, 2017
• Start date: October 15, 2016
• Est. completion date: June 1, 2018

Study information

• Verified date: October 2017
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Dutch Cancer Institute	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in health related quality of life	EORTC QLQ-C30	Baseline, month 1, month 3, month 5
Secondary	Change in need for supportive cancer care	Distress Thermometer	Baseline, month 1, month 3, month 5
Secondary	Satisfaction with (supportive) cancer care	(Adapted version of) Patient Satisfaction with Cancer Care	Month 5
Secondary	Change in consumption of supportive cancer care	(Adapted version of) Medical Consumption Questionnaire	Baseline, month 1, month 3, month 5
Secondary	Change in self-management	Study specific questions on knowledge and self-efficacy	Baseline, month 1, month 3, month 5
Secondary	Change in work productivity	Study specific questions on work productivity	Baseline and month 5
Secondary	Change in health status	EQ-5D-5L	Baseline and month 5