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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48483

Enrollment

Registered

2019-11-13

Start date

2020-02-28

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

maagdarmneoplasmata maligne Fear of cancer recurrence/ fear of progression of cancer

Interventions

The EMDR intervention consists of one preparation session of 90 minutes followed by weekly EMDR sessions of 90 minutes. Participants will receive a minimum of 2 and a maximum of 6 sessions including

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)