Cancer Clinical Trial
Official title:
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.
n/a
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