Lung Cancer Clinical Trial
Official title:
The PACO Project: A Randomized Clinical Study of a PAtient COach Program in Vulnerable Lung Cancer Patients
The randomized trial evaluates whether assigning a patient coach to vulnerable lung cancer patients will empower these patients to participate in the treatment decision process, help patients navigate the health care system while undergoing treatment and adhere to cancer treatment and to recommendations for supportive care. Half of the participants will receive standard care and be offered a patient coach while the other half will receive standard care.
Having short education or living without a partner negatively influences lung cancer
survival and low social position has been associated with higher risk of advanced stage of
the lung cancer at diagnosis. Disparities exists in both curative and palliative intended
treatment, even adjusted for performance status and comorbidity. Differences in stage,
treatment and comorbidity at diagnosis explain most of the social inequality in lung cancer
survival. Age disparities in favor of younger lung cancer patients has also been found in
several studies showing that older patients do not receive the most optimal treatment
although age by itself do not worsen efficacy or tolerance to combined induction and
definitive treatment, radiation therapy or concurrent chemoradiation. Taken together these
findings indicate that in order to reduce social inequality in lung cancer survival not only
early detection should be improved but also efforts to ensure optimal treatment among lung
cancer patients of low social position are needed. Survival observed in the most advantaged
group of lung cancer patients should set the target for what is achievable for all lung
cancer patients in Denmark.
In the present intervention the investigators bring navigation together with activation as a
longitudinal intervention by assigning a patient coach to vulnerable lung cancer patients
while undergoing treatment. The patient coach function will address patient barrier factors,
provider factors and organizational factors through providing social support, practical
assistance and linking with health personnel, which are the three main principles guiding
the coach intervention. The intervention will target specific phases in the treatment
trajectory, which include challenges to compliance: into treatment, maintaining treatment
and finalizing treatment. The investigators will use patient coaches who are volunteers with
health education to provide a support function that is affiliated to the patient. The
investigators believe that assistance with navigating the system, communication with health
staff and social support across care transitions will help patients to obtain best possible
care Primary aim: optimal treatment depending on stage, histology and performance status
Secondary aims: quality of life and symptoms, participation in self-management plans as
smoking cessation, physical activity, dietary changes, and short-term survival.
The investigators expect that compared to the usual care group the intervention group will
initiate and adhere more to optimal treatment according to stage and performance status.
Further, compared to the usual care group the intervention group will report better quality
of life, less symptoms related to disease and treatment, higher level of adherence to
recommendations for smoking, diet and exercise and better survival.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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