Cognitive behavior therapy (CBT) seems a promising intervention to reduce FCR. The SWORD study (Survivors* Worries of Recurrent Disease) will examine the efficacy and cost-effectiveness of individual CBT compared to treatment as usual (TAU) in…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Severity of fear of cancer recurrence (measured with the Cancer Worry Scale).
Secondary outcome
1. Disease specific quality of life (QLQ-C30), supplemented by a disease
specific module: BR23 for breast cancer, CR29 for colon cancer or PR25 for
prostate cancer. .
2. Satisfaction with (Quality of) Life (Satisfaction With Life Scale)
3. Cost-effectiveness and health-status (EQ-5D and patient diaries).
Other:
Mediators and moderators: Body Vigilance (Body Vigilance Scale), aspects of
fear of cancer recurrence (Fear of Cancer Recurrence Inventory) emotional
wellbeing (Hospital Anxiety and Depression Scale). Personality factors (The Big
Five Inventory) Optimism (Life Oriëntation Test), Social Support (Sociale Steun
Lijst- Discrepanties), fatigue (Verkorte Vermoeidheids Vragenlijst - 8) and
impact of events (Schokverwerkingslijst).
For both patient groups, also medical disease-specific data are collected.
Background summary
Fear of cancer recurrence (FCR) is a normal concern for cancer survivors who
have completed treatment and are in remission. Fear might be constructive, e.g.
keeping patients alert for symptoms indicating the possibility of recurrent
disease. However, even though fear of recurrence appears to be universal, some
survivors report more fear than others. This high level of fear is
characterized by a perceived risk of recurrence that is disproportionate to the
actual risk, functional impairment resulting from FCR, a long duration and
greater severity of the problem, frequent self-examination and demands for
medical tests for potential signs of recurrence. In literature, the percentages
of cancer survivors experiencing high levels of FCR range from 9-34% and seems
to become a chronic problem. Until now an evidence-based intervention
especially designed to assist patients in dealing with FCR is lacking in the
care for cancer survivors.
Study objective
Cognitive behavior therapy (CBT) seems a promising intervention to reduce FCR.
The SWORD study (Survivors* Worries of Recurrent Disease) will examine the
efficacy and cost-effectiveness of individual CBT compared to treatment as
usual (TAU) in managing FCR and thereby reducing related functional and
psychological consequences. Mediation analyses will be conducted to provide us
a more complete understanding of the mechanisms through which the intervention
might achieve its effect. In addition, moderators of treatment outcome will be
determined.
Study design
In this 2-arm randomized controlled trial (RCT) patients who are willing to
participate will be screened for the presence of high FCR by filling out a
questionnaire. Provided that they meet the inclusion criteria (see study
population) eligible patients will be randomly allocated to one of two
conditions, cognitive behavior therapy (CBT) or treatment as usual (TAU). While
both participants in the CGT and TAU condition will be asked to fill out
questionnaires, patients in the CGT condition will also receive a CGT
intervention. Assessments will take place at baseline (T1, time of inclusion).
After 3 months the second assessment will take place (T2). Between T1 and T2
the CBT will be carried out. The follow-up assessment will be administered at 6
months (T3) and one year (T4) after the intervention.
Intervention
The intervention will be developed by researchers and psychologists of the
department of Medical Psychology (UMC st. Radboud). Psychologists of this
department are specialized in treating cancer patients for different kind of
problems with CBT (depression, fatigue, anxiety). The proposed CBT intervention
consists of 6 to 8 individual, one hour sessions within 3 months by a trained
psychologist and is directed at change of cognitions and behaviour related to
FCR. In the last sessions (6-8) shared decision-making will take place in how
to continue therapy: face-to-face or by E-health.
Study burden and risks
There are no risks involved for the participating patients of this study. Only
time investment is asked regarding the completion of the questionnaires and/or
CBT treatment.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- Breast, colorectal and prostate cancer survivors up to 5 years after finishing primary treatment
- At the moment of the study disease-free, as defined by the absence of somatic disease activity parameters.
- Age of 18 and older.
- Cancer Worry Scale score of 14 or higher, indicating a high level of fear of cancer recurrence
- Sufficient understanding of the Dutch language to fill out questionnaires
- Able to travel to hospital for CBT intervention
Exclusion criteria
- Primary treatment completed less than 6 months ago.
- Currently in active (psychological/psychiatric) treatment for psychiatric comorbidity.
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 | NL41601.091.13 |