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  P3.24 - Poster Session 3 - Supportive Care (ID 160)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Supportive Care
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/30/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

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    P3.24-035 - Evaluating health related quality of life and symptoms by using the electronic (ePRO) version of the LCSS (eLCSS-QL) in a 622 patient prospective multinational NSCLC trial (AP-QL Trial) with good cross-cultural reliability. (ID 2397)

    09:30 - 09:30  |  Author(s): P.J. Hollen
    • Abstract

    Background
    Major goals in advanced NSCLC include accurate evaluation of survival and quality of life. Few trials evaluate both of these major endpoints well. In many studies, only a minority of patients have quality of life and other patient reported outcomes (PROs) such as symptoms systematically followed over time, which decreases the value of the assessment of the treatment. Prior studies have identified barriers to measuring quality of life in clinical trials and in practice. To overcome these barriers, we used a computer-assisted version of the validated LCSS measure and tested this prospectively in a large study in patients with Stage IV and IIIB NSCLC. The eLCSS-QL requires only two minutes for completion of the patient version and proved to be highly acceptable in earlier studies (Hollen, Supp Care Cancer 2012).

    Methods
    This trial was conducted at 65 sites in 9 Asian countries. 622 patients received first-line treatment with docetaxel -based chemotherapy. Patient demographics included: 70% male; 65% adenocarcinoma; median: KPS = 90; ECOG = 1 (27% ECOG 0). Stages: IV (72%), IIIB (28%). 84% had two or more major symptoms. 80% received combination chemotherapy with cisplatin (52%) or carboplatin (28%). The eLCSS-QL was completed every 3 weeks at the clinic. We also surveyed 98 physicians and nurses treating these patients regarding their experiences concerning communication, usefulness and acceptability of the eLCSS-QL.

    Results
    Ninety-seven percent of patients completed the eLCSS-QL at baseline; 90% completed follow-up evaluations. Over 90% found the eLCSS-QL easy to use and acceptable to complete at each visit. More than 80% of patients reported increased awareness of symptoms and that the quality of life evaluation made it easier to speak with doctors and nurses. 1% refused eLCSS-QL completion. Of physicians and nurses, more than 90% found the eLCSS-QL easy to use and increased symptom awareness; 80% reported improved communication, enhanced satisfaction with the patient visit, and would recommend its use to others. Nearly 90% of physicians reported they could identify benefit from chemotherapy earlier; 76% would order fewer imaging tests and 80% said the eLCSS-QL could save time. Cross-cultural testing was performed in this 9 nation trial. Cronbach’s alpha scores were high for each country, and exceeded 0.85 overall, demonstrating good cross-cultural reliability. Treatment outcomes: major response rate 37%; median survivals: 13.9 months (docetaxel + cisplatin), 12.7 months (docetaxel + carboplatin).

    Conclusion
    Placing the well validated LCSS onto an electronic platform (eLCSS-QL) helped overcome barriers to evaluating QL in this large clinical trial, with 90% of patients completing baseline and repeated QL measures. Patients, physicians, and nurses all found the eLCSS-QL to be highly acceptable and easy to use. The good cross-cultural aspects of the eLCSS-QL indicate that the electronic platform is particularly suitable for multinational trials. This large prospective trial demonstrates that improved compliance with quality of life and PRO evaluation is feasible and can easily be accomplished in large clinical trials. Additionally, the electronic format enhances the potential for the use of PROs in decision making in clinical practice.