The primary objective of the study is to measure the effect of a primary care intervention for fear of cancer recurrence (FCR), on the severity of FCR of patients who desire support for FCR, as compared to care as usual. Secondary objectives are to…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameter is the decrease in FCR severity as measured by the FCRI
severity scale, between baseline and T1 (three months after baseline).
Secondary outcome
Secondary parameters are difference in distress, FCR health care use and costs,
usual care, and satisfaction of patients and practitioners with the
intervention.
Background summary
One third of successfully treated cancer patients suffer from fear of cancer
recurrence (FCR). Effective treatments exist, but are not widely available. At
the same time, the role of primary care in cancer care and survivorship care is
increasing. Therefore, general practitioners (GP) and mental health workers
(MHW) working in primary care could play a role in supporting patients with
FCR.
Study objective
The primary objective of the study is to measure the effect of a primary care
intervention for fear of cancer recurrence (FCR), on the severity of FCR of
patients who desire support for FCR, as compared to care as usual. Secondary
objectives are to measure the effect of a primary care intervention for FCR, on
FCR-related distress, healthcare use and healthcare costs. Furthermore we will
qualitatively analyse the experience of patients, trained mental health workers
(MHW; in Dutch: POH-GGZ) and general practitioners (GP) with the FCR
intervention, and describe usual care for patients with FCR.
Study design
The BLANKET-study is a cluster randomized trial. GP practices will be invited
to participate in the study. Participating practices will be stratified by
practice characteristics and randomly placed in the intervention or the control
arm. In the intervention arm, practices will offer the FCR intervention; in the
control group, practices will provide care as usual.
Patients will be recruited through their GPs. Practices participating in the
study will send an invitation letter to patients registered at their practice,
who were curatively treated for cancer. Patients will be invited in rounds,
starting with those who most recently finished curative treatment. Patients who
desire support for FCR are asked to participate. After filling out the baseline
questionnaires, they visit the GP for a consultation on FCR support. Patients
also fill out questionnaires 3 months (T1) and 12 months (T2) after the
baseline. In addition, qualitative interviews are held after 3 months with a
selection of participants and data is collected from patients* Electronic
Health Records (EHR).
Intervention
In the intervention group, patients receive the FCR intervention. This
intervention follows a protocol that consists of five sessions with the MHW,
which focus on psycho-education, normalization and self-management. The
sessions are supported by intervention materials, which are available online or
on paper. The control group receives care as usual.
Study burden and risks
During the study, all patients fill out questionnaires three times at home (20
min each time). After the first questionnaire, patients are invited for an
intake with their GP about FCR care. In the intervention group, care will
include 5 sessions with the MHW, following a protocol. After three months, some
patients are invited for voluntary participation in qualitative interviews with
the researcher about the FCR intervention.
Professor Bronkhorstlaan 20
Bilthoven 3723 MB
NL
Professor Bronkhorstlaan 20
Bilthoven 3723 MB
NL
Listed location countries
Age
Inclusion criteria
• Having finished successful curative cancer treatment between 3 months and 10
years ago.
• Being registered at a general practice that is participating in the study.
• Being 18 years or older.
• Desiring support for FCR.
• Having sufficient Dutch reading and writing skills.
Exclusion criteria
Exclusion criteria for general practitioners (GP) and mental health workers
(MHW):
In some cases there are complex clusters where, for example, one GP works in
two practices, and a MHW in one of those practices works in a third practice,
as well. In these cases the practice where both the GP and the MHW work is
excluded to prevent contamination.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66988.041.18 |