|- candidate number||16376|
|- NTR Number||NTR4423|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-feb-2014|
|- Secondary IDs||2013/145 - NL41601.091.13 CMO Arnhem-Nijmegen|
|- Public Title||The SWORD-study: Managing fear of cancer recurrence.|
|- Scientific Title||The sword of Damocles. Managing fear of cancer recurrence with the SWORD-study (Survivors' Worries of Recurrent Disease).|
|- ACRONYM||The SWORD-Study|
|- Healt Condition(s) or Problem(s) studied||Cancer survivors, Fear of cancer recurrence |
|- Inclusion criteria||1. Histologically proven breast, colorectal or prostate cancer.
2. Primary curative-intent cancer treatment is completed between six months and five years ago.
3. Patients are disease-free at moment of study inclusion, as defined by the absence of somatic disease activity parameters;.
4. Patients are at least 18 years of age at time of inclusion (therefore defined as ‘adult’ by Dutch law);
5. Cancer Worry Scale score of 14 or higher, indicating a high level of fear of cancer recurrence.
6. Have sufficient Dutch language skills to complete questionnaires and engage in active conversation.
7. Patients are able to travel to hospital for CBT.
8. Are willing and able to give written informed consent according to legal requirements. |
|- Exclusion criteria||1. Primary curative-intent cancer treatment is completed less than 6 months ago.
2. Currently receiving psychological or psychiatric therapy for psychiatric co morbidity.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||2-feb-2014|
|- planned closingdate||2-feb-2017|
|- Target number of participants||108|
|- Interventions||The intervention is designed as blended care, combining traditional face-to-face cognitive behavior therapy (CBT) with online activities (psycho-education, assignments, assessments and therapist contact). If access to the website is not possible a workbook will be supplied instead. The CBT lasts three months and comprises five individual hourly face to face sessions, supplemented with three (15 minute) electronic consultations (‘e-consults’) or contact by telephone. The therapy protocol is based on a theoretical model by Lee-Jones (1997) which hypothesizes that an emotional reaction (fear) can be the result of interpretations and cognitions of the threat of cancer, triggered by perceptions of internal and/or external cues, leading to dysfunctional behavior and subsequently an increased fear response. The CBT is directed at change of the cognitions and behaviors managing FCR. It contains techniques commonly used in psychotherapy, such as cognitive reframing, exposure- and response prevention, psycho-education, mindfulness and relaxation exercises.|
|- Primary outcome||Fear of cancer recurrence as measured with the cancer worry scale (CWS).|
|- Secondary outcome||1. Disease specific quality of life (EORTC-QLQ-C30), supplemented by a disease specific module: BR23 for breast cancer, CR29 for colorectal cancer or PR25 for prostate cancer.
2. Satisfaction with Life (Satisfaction With Life – Scale)|
|- Timepoints||Patients will be asked to complete the described questionnaires at four different time points; baseline (T0, before randomization), 3 (T1), 9 (T2) and 15 months (T3) after random assignment.|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. M.A. Wal, van der|
|- CONTACT for SCIENTIFIC QUERIES||Drs. M. Gielissen|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Dutch Cancer Society|
|- Brief summary||Fear of Cancer Recurrence (FCR) is a normal and common concern for most cancer survivors. For up to 40% fear becomes a chronic problem. Few studies investigated interventions specifically designed for clinical levels of FCR. In a two-arm randomized controlled trial, among breast, prostate and colorectal cancer survivors, the efficacy of blended care will be compared to treatment as usual in managing FCR and thereby reducing related functional and psychological consequences. The intervention is based on principles of cognitive behavior therapy (CBT) and is directed at change of the cognitions and behaviors managing FCR. It is designed as blended care, combining face-to-face CBT with online activities (or workbook assignments). Primary and secondary outcome measures are severity of FCR, quality of life and satisfaction with life. At this moment, the effectiveness of the intervention is evaluated in a randomized trial carried out in the Netherlands. |
|- Main changes (audit trail)|
|- RECORD||12-feb-2014 - 6-apr-2014|