|- candidate number||15833|
|- NTR Number||NTR4309|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-dec-2013|
|- Secondary IDs||2012.WO26.C139 Pink Ribbon NL43781.091.13 Commissie Mensgebonden Onderzoek (Arnhem-Nijmegen)|
|- Public Title||Web-based cognitive behaviour therapy for severely fatigued breast cancer survivors.|
|- Scientific Title||Tired of being fatigued? Extending evidence-based treatment options for severely fatigued breast cancer survivors using the internet.|
|- hypothesis||Severe fatigue is a common complaint after completion of breast cancer treatment with curative intent. To extend treatment options for postcancer fatigue, the efficacy of an internet therapy with minimal therapist support is examined in the current study. There are three research questions:
1. What are the effects of internet therapy on fatigue severity compared to care as usual?
2. What are the effects of internet therapy on functional impairments, psychological distress and quality of life compared to care as usual?
3. Does time since end of cancer treatment moderate the effect of internet therapy?
|- Healt Condition(s) or Problem(s) studied||Fatigue, Breast cancer, Internet-interventions|
|- Inclusion criteria||1. Female.|
2. Treated for breast cancer with curative intent.
3. Primary cancer treatment (excluding hormone- and targeted therapy) must be completed since at least three months. There is no upper limit for the time since completion of cancer treatment.
4. Disease-free at start of the study.
5. Being severely fatigued (scoring >=35 on the subscale fatigue severity of the Checklist Individual Strength).
6. Age between 18 and 65.
7. Able to speak, read and write Dutch.
8. Having access to a computer with internet.
|- Exclusion criteria||1. Somatic co-morbidity that can explain the fatigue.|
2. Depressive disorder.
3. Current psychological treatment for a psychiatric disorder or fatigue.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2014|
|- planned closingdate||1-apr-2017|
|- Target number of participants||132|
|- Interventions||1. Internet therapy: patients in this condition will start with two face-to-face sessions with their therapist. Afterwards, they will follow the internet therapy for 6 months. Patients are invited to contact their therapist every three weeks to report on their progress and to receive feedback. The therapy is web-based version of a treatment protocol of cognitive behaviour therapy for postcancer fatigue. There are six treatment modules, aimed at fatigue-perpetuating factors. The intervention is tailor-made and will be completed with a face-to-face evaluation session. |
2. Care as usual: Patients assigned to this condition will be on a waiting list for six months. This waiting time is equal to the current waiting time in regular care.
|- Primary outcome||Fatigue severity, assessed with the subscale fatigue severity (¡Ý35) of the Checklist Individual Strength.|
|- Secondary outcome||1. Quality of life, assessed with the subscale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). |
2. Psychological distress, assessed with the total score on the Brief Symptom Inventory 18 (BSI-18)
3. Functional impairments, assessed with the total score on the Sickness Impact Profile-8 (SIP-8).
|- Timepoints||1. T0: Baseline assessment.|
2, T1: After the intervention or control condition (six months post-baseline).
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||PhD. J.A. Knoop|
|- CONTACT for SCIENTIFIC QUERIES||PhD. J.A. Knoop|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|- Brief summary||Approximately 40% of breast cancer survivors suffer from severe fatigue after completion of cancer treatment with curative intent. A randomised controlled trial (RCT) performed by our own research group has shown that face-to-face cognitive behaviour therapy (CBT) specifically designed for postcancer fatigue was effective. Unfortunately, treatment capacity is limited. To meet the need for evidence-based treatment for postcancer fatigue, a web-based version of the CBT with minimal therapist support is developed. The efficacy of the internet therapy will be determined in the CHANGE study. In addition, we will investigate if the time since completion of cancer treatment moderates the effects of the internet therapy on fatigue. At the moment, face-to-face CBT for postcancer fatigue is offered to survivors who finished cancer treatment at least one year previously. If CBT is already effective at 3 months after treatment, patients could receive treatment at an earlier stage. |
|- Main changes (audit trail)|
|- RECORD||6-dec-2013 - 15-apr-2016|