To investigate the efficacy of cognitive behaviour therapy (CBT) on reducing TTF in patients receiving TKIs for CML or GIST.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Fatigue severity is the primary outcome measure of the proposed SCE.
Secondary outcome
Not applicable
Background summary
Targeted therapies are a new generation of cancer drugs designed to interfere
with molecular targets critical for tumor growth and progression. One of the
first and most successful examples of targeted therapy is imatinib, a tyrosine
kinase inhibitor (TKI) developed for chronic myeloid leukemia (CML) but now
also applied in patients with a metastatic gastro-intestinal stromal tumour
(GIST). Although TKIs are much better tolerated than regimens they replaced,
they still posses side effects that are bothersome to patients, interfere with
quality of life (QoL), and contribute to problems with adherence. Since
treatment typically continues on a daily basis for many years and may be
life-long, effective management of side effects is critically important. Recent
studies show that fatigue is the most common symptom identified by patients
being treated with TKIs. The proposed study represents the first attempt to
address the problem of targeted therapy-related fatigue (TTF).
Study objective
To investigate the efficacy of cognitive behaviour therapy (CBT) on reducing
TTF in patients receiving TKIs for CML or GIST.
Study design
The research methodology used in the proposed research is a single-case
experiment (SCE). SCEs are experimental, and its purpose is to document causal
relationships between independent and dependent variables.
Intervention
Participants will receive CBT for fatigue in addition to usual care. CBT will
consist of approximately 14 individual one-hour sessions over a period of 26
weeks. The CBT will be given by trained therapists at the Expert Center for
Chronic Fatigue of the Radboud university medical center (Radboudumc). This
treatment is already part of routine care for severely fatigued patients who
have completed curative cancer treatment at least three months previously.
Study burden and risks
There are no or only minimal risks involved in participating in the CBT
intervention. The burden is limited and consists of extra travelling for the
sessions, following max. 14 sessions of CBT, and doing home-work assignments.
The program is adapted to the individual situation of the patient. Patients
fill out several questionnaires at baseline measurement, in order to determine
which topics need to be included in the CBT. During the complete study period
(min. 37 to max. 56 weeks) patients will complete a short weekly questionnaire.
This questionnaire can be completed online, via an iPod, or as a
paper-and-pencil version, within approximately 5-10 minutes. There are
substantial potential benefits for participants, as CBT for fatigued
disease-free cancer survivors already proved to be a highly effective
intervention in reducing fatigue and disabilities and it is likely that
patients with TTF will also profit and become less fatigued and disabled.
Reinier Postlaan 4
Nijmegen 6525GC
NL
Reinier Postlaan 4
Nijmegen 6525GC
NL
Listed location countries
Age
Inclusion criteria
• Age of 18 years or above;
• Able to speak, read, and write Dutch;
• Diagnosed with CML or GIST;
• Receiving (chronic) treatment with a tyrosine kinase inhibitor (TKI) for at least 3 months;
• Being severely fatigued (CIS fatigue >= 35), without known and treatable somatic causes for fatigue.
Exclusion criteria
• Receiving treatment for a psychiatric disorder
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 | NL51370.091.14 |