Moinpour, Carol M and Donaldson, Gary W and Nakamura, Yoshio (2009) Chemotherapeutic impact on pain and global health-related quality of life in hormone-refractory prostate cancer: Dynamically Modified Outcomes (DYNAMO) analysis of a randomized controlled trial. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 18 (2). pp. 147-155. ISSN 0962-9343
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Abstract
PURPOSE: This paper applies the Dynamically Modified Outcomes (DYNAMO) model to a clinical trial of two chemotherapeutic regimens on global health-related quality of life (GHRQL) in hormone-refractory prostate cancer. METHODS: DYNAMO identifies the causal influences operating in a clinical trial and their mediation, moderation, and modulation by uncontrolled variables. The Southwest Oncology Group trial S9916 randomized assignment to mitoxantrone plus prednisone (M + P) versus docetaxel plus estramustine (D + E) treatments. In this application, we examine baseline-adjusted impacts of worst pain (McGill Pain Questionnaire) on GHRQL (EORTC Quality of Life Questionnaire-C30) at 10 weeks. RESULTS: The average treatment levels of pain did not differ, hence, the average mediated effect of treatment on GHRQL was zero. Nonetheless, M + P reduced the impact (the relational outcome) of pain on GHRQL by 54% relative to D + E. Individual variation in the relational outcome (modulation) was of the same magnitude as the average difference between the groups. Performance status moderated the direct effects of treatment, with D + E being more effective in good, but not poor, performance strata. CONCLUSIONS: The DYNAMO approach comprehensively accounted for treatment effects. Rather than a single average effect, there were three distinct treatment effects: one direct effect for each performance status level and a direct effect on the relationship between pain and GHRQL.
| Item Type: | Article or Abstract |
|---|---|
| Additional Information: | The final publication is available at www.springerlink.com |
| DOI: | 10.1007/s11136-008-9433-3 |
| PubMed ID: | 19130298 |
| NIHMSID: | NIHMS190803 |
| PMCID: | PMC2859212 |
| Keywords or MeSH Headings: | Antineoplastic Combined Chemotherapy Protocols/therapeutic use; Estramustine/administration & dosage; Humans; Male; Mitoxantrone/administration & dosage; Models, Statistical; Neoplasms, Hormone-Dependent/drug therapy; Pain/drug therapy/etiology; Pain Measurement; Prednisone/administration & dosage; Prostatic Neoplasms/complications/drug therapy; Quality of Life; Randomized Controlled Trials as Topic/methods; Taxoids/administration & dosage; Treatment Outcome; |
| Subjects: | Research Methodologies > Clinical Trials Psychology > Pain Psychology > Quality of Life Diseases > Solid tumors > Prostate cancer Therapeutics > Drug Therapy |
| Depositing User: | Library Staff |
| Date Deposited: | 25 Mar 2010 15:49 |
| Last Modified: | 14 Feb 2012 14:43 |
| URI: | http://authors.fhcrc.org/id/eprint/414 |
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