The PACO Project: A Clinical Study of a PAtient COach Program in Vulnerable Lung Cancer Patients

Lung Cancer Clinical Trial

— PACO  

Official title:

The PACO Project: A Randomized Clinical Study of a PAtient COach Program in Vulnerable Lung Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02686775
• Other study ID #: R73-A4769-13-S17
• Status: Recruiting
• Phase: N/A
• First received: January 21, 2016
• Last updated: February 15, 2016
• Start date: January 2016
• Est. completion date: October 2018

Study information

• Verified date: February 2016
• Source: Danish Cancer Society
• Contact: Trille Kjaer, Postdoc
• Phone: +4535257608
• Email: trille[@]cancer.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 306
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosed with non-small cell lung cancer or small cell lung cancer

• Referred for further treatment at the oncology ward OR

• Must either 1) Live alone (irrespective of education) or 2) Have no formal education beyond secondary school, or 3) Have one or more comorbidities, or 4) a performance status of 1-2, or 5) be more than 65 years old at time of inclusion.

Exclusion Criteria:

• Dementia

• Being institutionalized

• No proficiency of Danish

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Social Inequality

Intervention

Behavioral:
• Patient coach

• Standard care

Locations

Country	Name	City	State
Denmark	Department of Oncology, Herlev Hospital	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Danish Cancer Society	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receipt of first-line treatment according to clinical guidelines reported as a binary variable (yes/no)	Optimal first line treatment will be defined according to TNM status and performance status and categorized receipt of first-line treatment as binary variable (yes/no).	20 weeks	No
Secondary	Differences between groups in overall quality of life using the generic EORTC QLQ-C30 questionnaire (overall quality of life and functioning levels) and the lung cancer specific questionnaire QLQ-LC13 (symptoms)		Then questionnaire will be distributed 3 times: 1) At treatment start (inclusion and baseline assessment), 2) end of treatment, approx. 20- 24 weeks after start of treatment (FU1) 3) one month after end of first line treatment (FU2)	No
Secondary	Differences between groups in patient knowledge, skill, and confidence for self-management as assessed by the Patient Activation Measure (PAM) questionnaire		The questionnaire will be distributed 3 times: At treatment start (inclusion and baseline assessment), 2) end of treatment, approx. 20- 24 weeks after start of treatment (FU1) 3) one month after end of first line treatment (FU2)	No
Secondary	Differences between groups in patients beliefs in the ability to deal efficiently with a wide range of stressors as assessed by the General Self-Efficacy Scale questionnaire		The questionnaire will be distributed 3 times: At treatment start (inclusion and baseline assessment), 2) end of treatment, approx. 20- 24 weeks after start of treatment (FU1) 3) one month after end of first line treatment (FU2)	No
Secondary	Participation in self-management plans regarding smoking cessation reported as binary variable (yes/no) as assessed by a study specific questionnaire and medical records		The outcome will be assessed at FU2 (one month after end of first line treatment)	No
Secondary	Differences between groups in depression and anxiety as assessed by the Hospital Anxiety and Depression Scale (HADS)		The questionnaire will be distributed 3 times: At treatment start (inclusion and baseline assessment), 2) end of treatment, approx. 20- 24 weeks after start of treatment (FU1) 3) one month after end of first line treatment (FU2)	No