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

February 15, 2016 updated by: Oksbjerg Dalton, Danish Cancer Society

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

306

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Recruiting
        • Department of Oncology, Herlev Hospital
        • Contact:
          • Anders Mellemgaard, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient coach
Standard care and patient coach. 5 face-to-face sessions of approximately 1-2 hours duration and 3 phone calls from inclusion to one month after end of first line treatment. Deviations from this schedule might depend on the treatment modules and on the wishes and needs of the patient. Several patients will continue directly into palliative care and the coach will thus support this transition.
Behavioral: Standard care
Behavioral: Patient coach
Active Comparator: Standard treatment
Standard care.
Behavioral: Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receipt of first-line treatment according to clinical guidelines reported as a binary variable (yes/no)
Time Frame: 20 weeks
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

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: 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)
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)
Differences between groups in patient knowledge, skill, and confidence for self-management as assessed by the Patient Activation Measure (PAM) questionnaire
Time Frame: 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)
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)
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
Time Frame: 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)
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)
Participation in self-management plans regarding smoking cessation reported as binary variable (yes/no) as assessed by a study specific questionnaire and medical records
Time Frame: The outcome will be assessed at FU2 (one month after end of first line treatment)
The outcome will be assessed at FU2 (one month after end of first line treatment)
Differences between groups in depression and anxiety as assessed by the Hospital Anxiety and Depression Scale (HADS)
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Cancer Society

Collaborators

University of Copenhagen

Investigators

  • Principal Investigator: Susanne O Dalton, Senior researcher, Danish Cancer Society Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

February 15, 2016

First Posted (Estimate)

February 22, 2016

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 15, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R73-A4769-13-S17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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