title: Development of a European Organization for Research and Treatment of Cancer questionnaire module to assess the quality of life of ovarian cancer patients in clinical trials: a progress report.
abstract: A questionnaire was developed, according to the European Organization for Research and Treatment of Cancer (EORTC) published guidelines, to supplement the EORTC quality of life questionnaire-core 30 (QLQ-C30) to assess the quality of life (QL) of women with ovarian cancer treated in clinical trials. The provisional 28-item module, OV28, assesses abdominal symptoms; peripheral neuropathy; other chemotherapy side-effects; hormonal symptoms; body image; attitude to disease and treatment; and sexual functioning. The first 24 items of the module (excluding sexual functioning) were included in a UK multicentre trial (SCOTROC). The trial data were used for preliminary scaling analysis. Two problematic items were identified. When these were treated as single items along with the 'other chemotherapy side-effects' the instrument showed excellent scale properties. Mean scale scores discriminated between trial patients pre- and on chemotherapy. This is a promising tool for assessing the QL of women with ovarian cancer. The EORTC international field study (Protocol 15982) to assess more fully the psychometric properties of the OV28 is well underway.
authors.affiliation: Imperial Cancer Research Fund Psychology Research Group, Western General Hospital, Crewe Road, EH4 2XU, Edinburgh, Scotland, UK. a.cull@icrf.icnet.uk
authors.forename: A
authors.initials: A
authors.lastname: Cull
authors.forename: S
authors.initials: S
authors.lastname: Howat
authors.forename: E
authors.initials: E
authors.lastname: Greimel
authors.forename: A C
authors.initials: AC
authors.lastname: Waldenstrom
authors.forename: J
authors.initials: J
authors.lastname: Arraras
authors.forename: A
authors.initials: A
authors.lastname: Kudelka
authors.forename: L
authors.initials: L
authors.lastname: Chauvenet
authors.forename: A
authors.initials: A
authors.lastname: Gould
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects*; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D011788:Quality of Life; D011795:Surveys and Questionnaires / Q000592:standards
chemical_list: D000970:Antineoplastic Agents