FREE study: investigating the effectiveness of EMDR as a treatment for Fear of Cancer Recurrence among cancer survivors.

Completed

Conditions: maagdarmneoplasmata maligne
Fear of cancer recurrence/ fear of progression of cancer
10006291
10002861

Registration Number: NL-OMON48483

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

Adult (18 - 70 years) survivors of breast cancer (female) or colon cancer
(male/female) after ending treatment. Participants must be able to rapport on a
daily basis on an online questionnaire, so minimal computer skills are
necessary. Participants with a low to normal score will not participate in
the treatment phase of the study. Participants with a score above 13 (cut of
score) on the CWS will be included for the treatment phase of the study.

Exclusion Criteria

Age under 18 years or over 70 years, obvious intellectual impairment, and
insufficient knowledge of the Dutch language. Patients with acute psychiatric
problems such as acute psychotic disorders or suicidality will be excluded.
Patients using medication that has an effect on anxiety need to be on stable
medication for at least three months and keep medication unchanged during the
study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure (Daily Questions FCR (DQ-FCR)) is an online list of<br /><br>5 questions based on the FCRI-NL severity scale, adapted for daily measurement,<br /><br>which are answered daily during 16 weeks (14 weeks of the study and 2 weeks<br /><br>follow-up).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome measures are the total score of the Cancer Worry Scale<br /><br>(CWS), Fear of Cancer Recurrence Inventory-Dutch version (FCRI-NL), 1 item<br /><br>about quality of life of the EORTC-QLQ-C-30. The questionnaires are filled in<br /><br>at t1 (at start of baseline period), t2 (at the end of baseline period = at<br /><br>start of EMDR), t3 (at the end of EMDR = at start of post-treatment period), t4<br /><br>(at the end of post-treatment period), and t5 (at the start of the follow-up<br /><br>period). Physical symptoms (Daily Questions Pain, Nausea, and Fatigue (DQ-PNF))<br /><br>measured daily during 16 weeks (14 weeks of the study and 2 weeks follow-up) is<br /><br>also a secondary outcome measure.</p><br>