title: Factors associated with non-participation and dropout among cancer patients in a cluster-randomised controlled trial.
abstract: We investigated the impact of demographic and disease related factors on non-participation and dropout in a cluster-randomised behavioural trial in cancer patients with measurements taken between hospitalisation and 6 months thereafter. The percentages of non-participation and dropout were documented at each time point. Factors considered to be potentially related with non-participation and dropout were as follows: age, sex, marital status, education, income, employment status, tumour site and stage of disease. Of 1,338 eligible patients, 24% declined participation at baseline. Non-participation was higher in older patients (Odds Ratio [OR] 2.1, CI: 0.6-0.9) and those with advanced disease (OR 2.0, CI: 0.1-1.3). Dropout by 6 months was 25%. Dropout was more frequent with increased age (OR 2.8, CI: 0.8-1.2), advanced disease (OR 3.0, CI: 1.0-1.2), being married (OR 2.4, CI 0.7-1.1) and less frequent with university education (OR 0.4, CI -1.3 to -0.8) and middle income (OR 0.4, CI -0.9 to -0.7). When planning clinical trials, it is important to be aware of patient groups at high risk of non-participation or dropout, for example older patients or those with advanced disease. Trial designs should consider their special needs to increase their rate of participation.
authors.affiliation: Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, Leipzig, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Roick
authors.affiliation: Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, Leipzig, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Danker
authors.affiliation: Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Leipzig, Leipzig, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Kersting
authors.affiliation: Department of Obstetrics and Gynecology, University Medical Center Leipzig, Leipzig, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Briest
authors.affiliation: Department of Visceral-, Transplantation-, Thoracic-, and Vascular Surgery, University Medical Center Leipzig, Leipzig, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Dietrich
authors.affiliation: Department of Otolaryngology, University Medical Center Leipzig, Leipzig, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Dietz
authors.affiliation: Department of Obstetrics and Gynecology, University Medical Center Leipzig, Leipzig, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Einenkel
authors.affiliation: Department of Radiation-Oncology, University Medical Center Leipzig, Leipzig, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Papsdorf
authors.affiliation: University Cancer Center, University Medical Center Leipzig, Leipzig, Germany.
authors.forename: F
authors.initials: F
authors.lastname: Lordick
authors.affiliation: Department of Neurosurgery, University Medical Center Leipzig, Leipzig, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Meixensberger
authors.affiliation: Department of Gastroenterology, University Medical Center Leipzig, Leipzig, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Mössner
authors.affiliation: Department of Hematology and Oncology, University Medical Center Leipzig, Leipzig, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Niederwieser
authors.affiliation: Department of Orthopedics and Accident Surgery, Helios Clinic Blankenhain, Blankenhain, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Prietzel
authors.affiliation: Department of Maxillofacial Surgery, University Medical Center Leipzig, Leipzig, Germany.
authors.forename: F
authors.initials: F
authors.lastname: Schiefke
authors.affiliation: Department of Urology, University Medical Center Leipzig, Leipzig, Germany.
authors.forename: J-U
authors.initials: JU
authors.lastname: Stolzenburg
authors.affiliation: Department of Pneumology, University Medical Center Leipzig, Leipzig, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Wirtz
authors.affiliation: Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Centre of Johannes Gutenberg University Mainz, Mainz, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Singer
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D016000:Cluster Analysis; D004522:Educational Status; D004651:Employment; D005260:Female; D006801:Humans; D007182:Income; D008297:Male; D017533:Marital Status; D008875:Middle Aged; D015999:Multivariate Analysis; D009369:Neoplasms / Q000628:therapy*; D016017:Odds Ratio; D010352:Patient Dropouts / Q000706:statistics & numerical data*; D010358:Patient Participation / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D011795:Surveys and Questionnaires; D055815:Young Adult
keywords: cancer; dropout; enrolment; lost to follow-up; non-participation; randomised controlled trial