Distress and quality of life after autologous stem cell transplantation: a randomized clinical trial to evaluate the outcome of a web-based stepped care intervention

BMC Cancer

Study Protocol

Pim Cuijpers¹  Corien Eeltink²  Peter C Huijgens²  Otto Visser²  Patricia van Oppen³  Annette D Boenink³  Annemarie MJ Braamse³  Aartjan TF Beekman³  Joost Dekker⁴  Berno van Meijel⁵ 

[1] Department of Clinical Psychology, FPP, EMGO Institute for Health and Care Research, VU University, Amsterdam, The Netherlands;Department of Hematology, VU University Medical Center, Amsterdam, The Netherlands;Department of Psychiatry and EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands;Department of Psychiatry and EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands;Department of Clinical Psychology, FPP, EMGO Institute for Health and Care Research, VU University, Amsterdam, The Netherlands;Inholland University, Research Group Mental Health Nursing, Amsterdam, The Netherlands;

关键词: Psychological Distress;    Hematological Malignancy;    Nurse Practitioner;    Autologous Stem Cell Transplantation;    Composite International Diagnostic Interview;   

DOI  :  10.1186/1471-2407-10-361

 received in 2009-12-03, accepted in 2010-07-07,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundPsychological distress (i.e. depression and anxiety) is a strong predictor of functional status and other aspects of quality of life in autologous stem cell transplantation following high-dose chemotherapy. Treatment of psychological distress is hypothesized to result in improvement of functional status and other aspects of quality of life. The aim is to evaluate the outcome of stepped care for psychological distress on functional status and other aspects of quality of life in patients with hematological malignancy treated with autologous stem cell transplantation.Methods/DesignThe study is designed as a randomized clinical trial with 2 treatment arms: a stepped care intervention program versus care as usual. Patients are randomized immediately pre transplant. Stepped care and care as usual are initiated after a 6 weeks buffer period. Outcome is evaluated at 13, 30, and 42 weeks post transplant.In the experimental group, the first step includes an Internet-based self-help program. If psychological distress persists after the self-help intervention, the second step of the program is executed, i.e. a diagnostic evaluation and a standardized interview, yielding a problem analysis. Based on this information, a contract is made with the patient and treatment is provided consisting of individual face-to-face counseling, medication, or referral to other services. Care as usual comprises an interview with the patient, on ad hoc basis; emotional support and advice, on ad hoc basis; if urgent problems emerge, the patient is referred to other services.Primary outcome variables are psychological distress and functional status. Data are analyzed according to the intention to treat-principle.DiscussionThis study has several innovative characteristics. First, the outcome of the intervention for psychological distress in patients with hematological malignancy treated with autologous stem cell transplantation is evaluated in a randomized controlled study. Second, the impact of the intervention on functional status is evaluated: it is hypothesized that reduction of psychological distress results in improved functional status. Furthermore, the intervention concerns an Internet-based treatment in the first step. Finally, the intervention is characterized by an emphasis on self-management, efficiency, and a multi-disciplinary approach with nurses taking up a central role.Trial RegistrationNTR1770

【 授权许可】

CC BY   
© Braamse et al; licensee BioMed Central Ltd. 2010