Primary Objective: • To explore the effectiveness of EMDR therapy treatment in reducing symptoms of chemotherapy-induced conditioned nausea and vomiting in (former) patients with cancer.Secondary Objective:• To explore impact on QoL of chemotherapy-…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in degree of conditioned nausea and vomiting after exposure to
conditioned stimuli measured before and after EMDR therapy using the nausea
profile questionnaire.
Secondary outcome
Impact on QoL of conditioned nausea and vomiting using Functional Living Index
- Emesis (FLIE) questionnaire.
Background summary
Conditioned nausea and vomiting is a common side effect of anti-cancer
treatment, and while strategies like antiemetics exist, their effectiveness is
limited. Conditioned nausea and vomiting can possibly be addressed through Eye
Movement Desensitization and Reprocessing (EMDR) therapy. EMDR therapy is a
therapeutic intervention, proven to be effective in the treatment of
post-traumatic stress disorder (PTSD), and promising in treating a range of
other conditions. At the UMCG, EMDR therapy is used on a small scale to treat
conditioned nausea with positive results, although more rigorous research is
needed to fully establish its efficacy.
Study objective
Primary Objective:
• To explore the effectiveness of EMDR therapy treatment in reducing symptoms
of chemotherapy-induced conditioned nausea and vomiting in (former) patients
with cancer.
Secondary Objective:
• To explore impact on QoL of chemotherapy-induced conditioned nausea and
vomiting in (former) patients with cancer.
Study design
This exploratory study will focus on patients who were previously treated with
chemotherapy at the Hematology, Pulmonary Oncology and Medical Oncology
Departments of the UMCG. Potential participants are identified by the medical
oncologists, pulmonologists, hematologists, psychologists, and dietitians of
the UMCG during a regular hospital visit. They will introduce the study to the
patient and will ask the potential participants permission to give them a
letter from the investigators containing study details.
The study will also be promoted via Hematon region Groningen/Drenthe, the Dutch
organization for patients with a hematological malignancy. In addition, an
announcement will be made via a poster in the outpatient clinic waiting room at
the UMCG. At last, information about the study will be posted on the medical
oncology website of the UMCG. Patients can contact the study team if they wish
to receive the study details. After receiving the letter, both patient groups
will be called after two weeks to ask if they are willing to participate in the
study.
If participants are willing to participate, they will be asked to fill in an
online questionnaire via REDcap with questions regarding the conditioned
stimulus, complaints after exposure to the conditioned stimulus, possible
exclusion criteria, and nausea and treatment of nausea during chemotherapy
treatment. Furthermore, they will fill in the Functional Living Index - Emesis
(FLIE) questionnaire. An appointment will be scheduled with one of the UMCG
psychologists. If patients have no questions regarding the study or the study
information that was sent, they are asked to sign the informed consent. Next,
the degree of conditioned nausea and vomiting will be measured by exposing the
participant to the conditioned stimuli, followed by filling in the nausea
profile questionnaire about the experienced nausea and vomiting (primary
endpoint). Afterwards, the first EMDR therapy session is applied by the
hospital psychologist. After 1-3 EMDR therapy sessions, conditioned nausea and
vomiting will again be measured after exposure to the conditioned stimuli with
the nausea profile questionnaire. At last, the background of the participant
will be collected from the patients electronic medical file, including cancer
type, type(s) of earlier treatment, duration of treatment, age, gender,
medication, and medical psychiatric history. Participants who are not UMCG
patients will answer these questions on paper after filling in the nausea
profile questionnaire.
Intervention
In this study, EMDR therapy will be performed by psychologists of the UMCG who
are trained in EMDR therapy and who have experience with patients with somatic
diseases. In the EMDR therapy protocol, the patient is guided through eight
phases which incorporate dual focus of attention and alternating bilateral
visual, auditory, and/or tactile stimulation (see supplement for protocol). The
number of sessions varies per patient (1-3 sessions), depending on the
desensitization of the conditioned stimuli. The sessions will last 60-90
minutes.
EMDR therapy has been utilized in clinical settings for decades, accumulating a
substantial body of evidence supporting its safety and efficacy, even in
patients with underlying psychological distress like psychosis (18). Numerous
studies and meta-analyses have consistently demonstrated its effectiveness in
reducing symptoms of PTSD and conditions. The standardized EMDR therapy
protocol used by the UMCG psychologists, and their training ensure the safety
of the participants.
Study burden and risks
Not applicable
*
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
o Previously pathologically confirmed diagnosis of cancer
o Previously treated with systemic cancer therapy
o Persistent complaints (>2 months) of conditioned nausea and/or vomiting
o Able to understand spoken and written Dutch
o 18 years or older
Exclusion criteria
o Ongoing psychiatric treatment
o EMDR therapy contraindications (dissociative disorders, personality disorders
or severe somatic disorders (e.g. cardiac arrhythmias))
o Complex type 2 trauma
o Known with recent conditions / non-anti-cancer medication which can elicit
nausea (e.g. pregnancy or alcohol abuses)
Design
Recruitment
Medical products/devices used
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 | NL87087.042.24 |
Other | volgt |