K Holtmaat, F E van Beek, L M A Wijnhoven, J A E Custers, E J Aukema, S E J Eerenstein, I M van Oort, J E M Werner, J A Wegdam, I L E Jansen-Engelen, I H J T de Hingh, S Verheul, D T van der Beek, G Wekking, I Steggerda, V M H Coupé, N Horevoorts, A M de Korte, C Lammens, B I Lissenberg-Witte, B H de Rooij, J B Prins, I M Verdonck-de Leeuw, F Jansen
{"title":"针对癌症患者适应障碍的量身定制心理干预方案的疗效和预算影响：一项随机对照试验。","authors":"K Holtmaat, F E van Beek, L M A Wijnhoven, J A E Custers, E J Aukema, S E J Eerenstein, I M van Oort, J E M Werner, J A Wegdam, I L E Jansen-Engelen, I H J T de Hingh, S Verheul, D T van der Beek, G Wekking, I Steggerda, V M H Coupé, N Horevoorts, A M de Korte, C Lammens, B I Lissenberg-Witte, B H de Rooij, J B Prins, I M Verdonck-de Leeuw, F Jansen","doi":"10.1002/pon.70123","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Evidence on the efficacy of psychological interventions targeting cancer patients diagnosed with an adjustment disorder is scarce.</p><p><strong>Aims: </strong>This study aimed to investigate the efficacy and budget impact of a tailored psychological intervention program (AD-program) targeting cancer patients with adjustment disorder (AD).</p><p><strong>Methods: </strong>Patients (n = 59) were randomised to the intervention or control group. The AD-program consisted of three modules: psychoeducation (1-4 sessions) and two additional modules (maximum of 6 sessions per module) provided when needed. The primary outcome was psychological distress (HADS). Secondary outcomes were mental adjustment to cancer (MAC) and health-related quality of life (EORTC QLQ-C30). Measures were completed at baseline and 3 and 6 months after randomisation. The budget impact analyses were based on the population size, the costs of the AD-program, and other costs potentially affected by the AD-program.</p><p><strong>Results: </strong>The mean psychological distress score in the intervention group (n = 33) decreased over time (M = 19.2 at T0, M = 15.6 at T6). This decrease was not significantly different from decrease in the control condition (n = 26, M = 17.5 at T0, M = 15.9 at T6, p > 0.05). Also, there were no significant differences between the two conditions on the secondary outcomes. The budget impact of the AD-program was estimated at 7-28 million euros per year (to treat 14,430 patients).</p><p><strong>Conclusions: </strong>The effect of the AD-program was not statistically significant in this RCT. Limitations include that this study was underpowered due to recruitment difficulties during the COVID-19 pandemic. More research on the efficacy and implementation of the AD-program is warranted.</p><p><strong>Trial registration: </strong>Netherlands Trial Register identifier: NL7763. Registered on 3 June 2019.</p>","PeriodicalId":20779,"journal":{"name":"Psycho‐Oncology","volume":"34 3","pages":"e70123"},"PeriodicalIF":3.3000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11910135/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Budget Impact of a Tailored Psychological Intervention Program Targeting Cancer Patients With Adjustment Disorder: A Randomised Controlled Trial.\",\"authors\":\"K Holtmaat, F E van Beek, L M A Wijnhoven, J A E Custers, E J Aukema, S E J Eerenstein, I M van Oort, J E M Werner, J A Wegdam, I L E Jansen-Engelen, I H J T de Hingh, S Verheul, D T van der Beek, G Wekking, I Steggerda, V M H Coupé, N Horevoorts, A M de Korte, C Lammens, B I Lissenberg-Witte, B H de Rooij, J B Prins, I M Verdonck-de Leeuw, F Jansen\",\"doi\":\"10.1002/pon.70123\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Evidence on the efficacy of psychological interventions targeting cancer patients diagnosed with an adjustment disorder is scarce.</p><p><strong>Aims: </strong>This study aimed to investigate the efficacy and budget impact of a tailored psychological intervention program (AD-program) targeting cancer patients with adjustment disorder (AD).</p><p><strong>Methods: </strong>Patients (n = 59) were randomised to the intervention or control group. The AD-program consisted of three modules: psychoeducation (1-4 sessions) and two additional modules (maximum of 6 sessions per module) provided when needed. The primary outcome was psychological distress (HADS). Secondary outcomes were mental adjustment to cancer (MAC) and health-related quality of life (EORTC QLQ-C30). Measures were completed at baseline and 3 and 6 months after randomisation. The budget impact analyses were based on the population size, the costs of the AD-program, and other costs potentially affected by the AD-program.</p><p><strong>Results: </strong>The mean psychological distress score in the intervention group (n = 33) decreased over time (M = 19.2 at T0, M = 15.6 at T6). This decrease was not significantly different from decrease in the control condition (n = 26, M = 17.5 at T0, M = 15.9 at T6, p > 0.05). Also, there were no significant differences between the two conditions on the secondary outcomes. The budget impact of the AD-program was estimated at 7-28 million euros per year (to treat 14,430 patients).</p><p><strong>Conclusions: </strong>The effect of the AD-program was not statistically significant in this RCT. Limitations include that this study was underpowered due to recruitment difficulties during the COVID-19 pandemic. More research on the efficacy and implementation of the AD-program is warranted.</p><p><strong>Trial registration: </strong>Netherlands Trial Register identifier: NL7763. 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Efficacy and Budget Impact of a Tailored Psychological Intervention Program Targeting Cancer Patients With Adjustment Disorder: A Randomised Controlled Trial.
Background: Evidence on the efficacy of psychological interventions targeting cancer patients diagnosed with an adjustment disorder is scarce.
Aims: This study aimed to investigate the efficacy and budget impact of a tailored psychological intervention program (AD-program) targeting cancer patients with adjustment disorder (AD).
Methods: Patients (n = 59) were randomised to the intervention or control group. The AD-program consisted of three modules: psychoeducation (1-4 sessions) and two additional modules (maximum of 6 sessions per module) provided when needed. The primary outcome was psychological distress (HADS). Secondary outcomes were mental adjustment to cancer (MAC) and health-related quality of life (EORTC QLQ-C30). Measures were completed at baseline and 3 and 6 months after randomisation. The budget impact analyses were based on the population size, the costs of the AD-program, and other costs potentially affected by the AD-program.
Results: The mean psychological distress score in the intervention group (n = 33) decreased over time (M = 19.2 at T0, M = 15.6 at T6). This decrease was not significantly different from decrease in the control condition (n = 26, M = 17.5 at T0, M = 15.9 at T6, p > 0.05). Also, there were no significant differences between the two conditions on the secondary outcomes. The budget impact of the AD-program was estimated at 7-28 million euros per year (to treat 14,430 patients).
Conclusions: The effect of the AD-program was not statistically significant in this RCT. Limitations include that this study was underpowered due to recruitment difficulties during the COVID-19 pandemic. More research on the efficacy and implementation of the AD-program is warranted.
Trial registration: Netherlands Trial Register identifier: NL7763. Registered on 3 June 2019.
期刊介绍：
Psycho-Oncology is concerned with the psychological, social, behavioral, and ethical aspects of cancer. This subspeciality addresses the two major psychological dimensions of cancer: the psychological responses of patients to cancer at all stages of the disease, and that of their families and caretakers; and the psychological, behavioral and social factors that may influence the disease process. Psycho-oncology is an area of multi-disciplinary interest and has boundaries with the major specialities in oncology: the clinical disciplines (surgery, medicine, pediatrics, radiotherapy), epidemiology, immunology, endocrinology, biology, pathology, bioethics, palliative care, rehabilitation medicine, clinical trials research and decision making, as well as psychiatry and psychology.
This international journal is published twelve times a year and will consider contributions to research of clinical and theoretical interest. Topics covered are wide-ranging and relate to the psychosocial aspects of cancer and AIDS-related tumors, including: epidemiology, quality of life, palliative and supportive care, psychiatry, psychology, sociology, social work, nursing and educational issues.
Special reviews are offered from time to time. There is a section reviewing recently published books. A society news section is available for the dissemination of information relating to meetings, conferences and other society-related topics. Summary proceedings of important national and international symposia falling within the aims of the journal are presented.
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