|- candidate number||5634|
|- NTR Number||NTR1770|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-apr-2009|
|- Secondary IDs||2008/289 METC VU University Medical Center|
|- Public Title||Distress and quality of life in autologous stem cell transplantation: stepped care.|
|- Scientific Title||Distress and quality of life of patients treated with autologous stem cell transplantation following high-dose chemotherapy: outcome of stepped care.|
|- hypothesis||Evaluation of 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 following high-dose chemotherapy.|
|- Healt Condition(s) or Problem(s) studied||Depression, Non Hodkin's lymfoma (NHL), Anxiety, Acute Lymfatic Leukemia (ALL), Hematological malignancy, Multiple myeloma|
|- Inclusion criteria||1. Patients with hematological malignancy (multiple myeloma, (relapsed) (non-)Hodgkin lymphoma, acute myeloid leukemia, or acute lymphoid leukemia) treated with autologous stem cell transplantation following high-dose chemotherapy;|
2. Life expectation > 3 months.
|- Exclusion criteria||1. Age < 18 or > 65 years (65 is included);|
2. Insufficient command of the Dutch language to complete questionnaires; or, if so: no support by family or professional interpreters;
3. Contra-indication for the stepped care approach;
4. No informed consent.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2009|
|- planned closingdate||1-nov-2013|
|- Target number of participants||128|
|- Interventions||Protocol stepped care:|
1. Step 1: Internet based self-help program ('Alles onder controle': a brief web based intervention for problem-solving which is based on self-examination therapy);
2. Step 2: The following treatment options are available in step 2: individual face-to-face counseling, medication, referral to other services.
|- Primary outcome||Psychological distress (measured with the HADS) and physical role function (subscale from the EORTC-QLQ-C30).|
|- Secondary outcome||Other measures of psychological distress (PHQ-9, STAI-state), other aspects of quality of life (EORTC-QLQ-C30, SF-36), cognitions and coping (DGSS, SPSI-R).|
|- Timepoints||1. T0: pre-transplant;|
2. T10: ten weeks post transplant;
3. T24: twenty-four weeks post transplant;
4. T36: thirty-six weeks post transplant.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| A.M.J. Braamse|
|- CONTACT for SCIENTIFIC QUERIES||Prof.dr. J. Dekker|
|- Sponsor/Initiator ||Inholland University, Research Group Mental Health Nursing, VU University Medical Center|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background: |
Psychological 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 (aSCT). Treatment of psychological distress is hypothesized to result in improvement in psychological distress, and thereby in improvement of functional status and other aspects of quality of life. Treatment for psychological distress will be delivered according to the stepped care approach: a less intensive intervention (i.e. internet based self-help program) is tried first, with more intensive and costly interventions (i.e. individual face-to-face counseling, medication, or planned referral to other services) reserved for those insufficiently helped by the initial intervention.
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 following high-dose chemotherapy.
Pragmatic randomized clinical trial with 2 treatment arms: stepped care and care as usual. Patients treated with aSCT are randomized immediately pre transplant (T0) to stepped care or care as usual. Stepped care and care as usual are initiated after a 3 weeks buffer period. Outcome is evaluated at 10 weeks (T10), 24 weeks (T24) and 36 weeks (T36) post transplant.
The steps include (i) internet based self-help program (based on the principles of problem solving therapy). If psychological distress persists after the self-help intervention, a diagnostic evaluation, standardized interview and problem analysis are performed. Based on this information, (ii) a contract is made with the patient on the next step and treatment is provided consisting of individual face-to-face counseling (based on the principles of problem solving therapy), medication, or planned referral to other services.
Care as usual:
Interview with patient, on ad hoc basis; emotional support and advise, on ad hoc basis; if urgent problems emerge, referral to other services.
Evaluation of outcome:
Primary outcome variables are psychological distress and functional status. Data are analyzed according to the intention to treat principle. The study is powered to detect a moderate effect size (d=0.5).
|- Main changes (audit trail)|
|- RECORD||20-apr-2009 - 30-jun-2015|