TY - JOUR
T1 - Prevalence of adjustment disorder among cancer patients, and the reach, effectiveness, cost-utility and budget impact of tailored psychological treatment: Study protocol of a randomized controlled trial
T2 - Study protocol of a randomized controlled trial
AU - van Beek, Florie E.
AU - Wijnhoven, Lonneke M. A.
AU - Jansen, Femke
AU - Custers, José A. E.
AU - Aukema, Eline J.
AU - Coupé, Veerle M. H.
AU - Cuijpers, Pim
AU - van der Lee, Marije L.
AU - Lissenberg-Witte, Birgit I.
AU - Wijnen, Ben
AU - Prins, Judith B.
AU - Verdonck-de Leeuw, Irma M.
PY - 2019/12/23
Y1 - 2019/12/23
N2 - Background: Information on the prevalence of adjustment disorders among cancer patients and the value of psychological interventions in this group of patients is limited. This study investigates the prevalence of adjustment disorders among cancer patients as well as the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention. Method: This study consists of two parts. Part 1 is an observational study among a representative group of mixed cancer patients after cancer treatment on the prevalence of adjustment disorder as well as the uptake (i.e. reach) of psychological treatment. In Part 2, patients diagnosed with an adjustment disorder are invited to participate in a randomized controlled trial. Patients will be randomized to the intervention (access to the tailored psychological intervention) or control group (waitlist period of 6 months). The psychological intervention consists of three modules: One module containing psycho-education (3 sessions, all patients) and two additional modules (maximum of 6 sessions per module) provided as continuum, in case needed. Module 2 and 3 can consist of several evidence-based interventions (e.g. group interventions, mindfulness, eHealth) The primary outcome is psychological distress (HADS). Secondary outcomes are mental adjustment to cancer (MAC) and health-related quality of life (EORTC QLQ-C30). To assess the cost-utility and budget impact, quality of life (EQ-5D-5 L) and costs (iMCQ and iPCQ) will be measured. Measures will be completed at baseline and 3 and 6-months after randomization. Discussion: This study will provide data of the prevalence of adjustment disorders and the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention. Trial registration: Netherlands Trial Register identifier: NL7763. Registered on 3 June 2019.
AB - Background: Information on the prevalence of adjustment disorders among cancer patients and the value of psychological interventions in this group of patients is limited. This study investigates the prevalence of adjustment disorders among cancer patients as well as the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention. Method: This study consists of two parts. Part 1 is an observational study among a representative group of mixed cancer patients after cancer treatment on the prevalence of adjustment disorder as well as the uptake (i.e. reach) of psychological treatment. In Part 2, patients diagnosed with an adjustment disorder are invited to participate in a randomized controlled trial. Patients will be randomized to the intervention (access to the tailored psychological intervention) or control group (waitlist period of 6 months). The psychological intervention consists of three modules: One module containing psycho-education (3 sessions, all patients) and two additional modules (maximum of 6 sessions per module) provided as continuum, in case needed. Module 2 and 3 can consist of several evidence-based interventions (e.g. group interventions, mindfulness, eHealth) The primary outcome is psychological distress (HADS). Secondary outcomes are mental adjustment to cancer (MAC) and health-related quality of life (EORTC QLQ-C30). To assess the cost-utility and budget impact, quality of life (EQ-5D-5 L) and costs (iMCQ and iPCQ) will be measured. Measures will be completed at baseline and 3 and 6-months after randomization. Discussion: This study will provide data of the prevalence of adjustment disorders and the reach, effectiveness, cost-utility and budget impact of a tailored psychological intervention. Trial registration: Netherlands Trial Register identifier: NL7763. Registered on 3 June 2019.
KW - Adjustment disorder
KW - Cancer patients
KW - Psychological distress
KW - Psychological intervention
KW - Randomized controlled trial
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85077048549&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/31870421
UR - http://www.scopus.com/inward/record.url?scp=85077048549&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85077048549&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s40359-019-0368-y
DO - https://doi.org/10.1186/s40359-019-0368-y
M3 - Article
C2 - 31870421
SN - 2050-7283
VL - 7
JO - BMC Psychology
JF - BMC Psychology
IS - 1
M1 - 89
ER -
