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.
Subject(s)
Neoplasms/therapy , Patient Dropouts/statistics & numerical data , Patient Participation/statistics & numerical data , Randomized Controlled Trials as Topic , Adult , Age Factors , Aged , Aged, 80 and over , Cluster Analysis , Educational Status , Employment , Female , Humans , Income , Male , Marital Status , Middle Aged , Multivariate Analysis , Odds Ratio , Risk Factors , Surveys and Questionnaires , Young AdultABSTRACT
BACKGROUND: Social networks and social participation generally have positive effects on health. Yet, little is known about how patients after total laryngectomy (TLE) are integrated into the society. Aim of this study was to investigate how patients are socially integrated after a TLE and if social integration is associated with certain areas of quality of life. PATIENTS AND METHODS: In a longitudinal multi-centred study 161 laryngectomees were interviewed 1 year after the total laryngectomy. Social integration was measured on the basis of an index formed by the questionnaire "Psychosocial Adjustment after Laryngectomy" and questions about social support. To assess quality of life, we used the questionnaire from the European Organisation for Research and Treatment of Cancer EORTC QLQ-C30. RESULTS: 58% of all patients are well integrated 1 year after surgery. Well integrated persons have less problems in different components of quality of life. They report higher levels of social (OR 4.07; CI: 1.96-8.47) and role functioning (OR 3.59; CI: 1.61-8.02). Successful social integration is also associated with higher emotional well-being (OR 8.57; CI: 3.59-20.46). CONCLUSIONS: There is evidence that 1 year after TLE only about half of the patients feel socially integrated. Because of the negative association of poor social integration with social, emotional and role functioning, patients should be supported in their attempts to take actively part in social life.
