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

NCT02686775 | Unknown

• 1 other identifier: R73-A4769-13-S17
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer; Social Inequality

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Patient coach

EXPERIMENTAL

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: Patient coach; Behavioral: Standard care

Standard treatment

ACTIVE COMPARATOR

Standard care.

Behavioral: Standard care

Interventions

Patient coach BEHAVIORAL

Patient coach

Standard care BEHAVIORAL

Patient coach; Standard treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with non-small cell lung cancer or small cell lung cancer
• Referred for further treatment at the oncology ward OR

You may not qualify if:

• Dementia
• Being institutionalized
• No proficiency of Danish

Sponsors & Collaborators

• Danish Cancer Society: lead
• University of Copenhagen: collaborator

Study Sites (1)

Department of Oncology, Herlev Hospital

Herlev, Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Susanne O Dalton, Senior researcher

  Danish Cancer Society Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trille Kjaer, Postdoc

CONTACT

+4535257608; trille@cancer.dk

Susanne O Dalton, Senior researcher

CONTACT

sanne@cancer.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: February 22, 2016
• Study Start: January 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: February 22, 2016

Record last verified: 2016-02

Locations

DK (1)