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. 2018 Jul 19;2018(7):CD006732. doi: 10.1002/14651858.CD006732.pub4

NCT02686775.

Trial name or title The PACO Project: A Clinical Study of a PAtient COach Program in vulnerable lung cancer patients (PACO)
Methods RCT
Participants 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
Interventions 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.
Active Comparator: standard treatment
Standard care
Outcomes Primary outcome

  • Receipt of first‐line treatment according to clinical guidelines reported as a binary variable (yes/no)


Secondary outcomes

  • 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)

  • Differences between groups in patient knowledge, skill, and confidence for self‐management as assessed by the Patient Activation Measure (PAM) questionnaire

  • 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

  • Participation in self‐management plans regarding smoking cessation reported as binary variable (yes/no) as assessed by a study specific questionnaire and medical records

  • Differences between groups in depression and anxiety as assessed by the Hospital Anxiety and Depression Scale (HADS)
Starting date January 2016
Contact information Trille Kjaer, Postdoc, +4535257608, trille@cancer.dk and Susanne O Dalton, Senior researcher, sanne@cancer.dk
Notes