Clinical trial · Interventional
Cognitive Behavioral Therapy for Fear of Cancer Recurrence in Women With BRCA1/2 Gene
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to determine whether an adapted version of a current cognitive-behavioural group therapy (CBT) protocol for cancer survivors to the specific needs of women who are carriers of the BRCA1/2 genetic mutation will reduce their levels of fear of cancer recurrence. The main questions this study aims to answer are: * Will the women who have received the adapted CBT be satisfied with it? * Will there be a significant difference in the women's fear of cancer recurrence and other variables (e.g., depression, anxiety, insomnia, fatigue, quality of life) between the comparison groups? * Will the effects of the adapted CBT hold over time? * What are the roles of different etiological mediating variables in the relationship between fear of cancer recurrence and the effects of the adapted CBT on the severity of fear of cancer recurrence? Researchers will compare the effects of the adapted CBT between the immediate condition and the waitlist condition. Participants will be: * Either placed in the immediate condition or the waitlist condition (the participants in the waitlist condition will begin their therapy once the immediate group is done with theirs). * Taking part in a group CBT session online once a week for eleven weeks. * Completing questionnaires pre-intervention, post-intervention, 3 months post-intervention, and 6 months post-intervention.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA2 Mutation | — | UNRESOLVED | — |
| Breast Cancer Susceptibility Gene (BRCA1) Mutation | — | UNRESOLVED | — |
| Fear of Cancer Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive-behavioral group therapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immediate intervention
- description
- This group will start as soon as between 5-8 persons have been recruited and randomized into the immediate intervention group.
- interventionNames
- Behavioral: Cognitive-behavioral group therapy
- type
- ACTIVE_COMPARATOR
- label
- Waiting list group
- description
- This group will wait for 7 weeks after being recruited before starting the same intervention as the immediate intervention group.
- interventionNames
- Behavioral: Cognitive-behavioral group therapy
Primary outcomes (1)
- measure
- Fear of cancer recurrence inventory (FCRI)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\) Have completed primary treatment for breast or ovarian cancer (i.e., surgery, chemotherapy, and radiotherapy). * 2\) Be known to carry a BRCA1/2 pathogenic mutation. * 3\) Have a clinical level of fear of cancer recurrence as defined by a score of 13 or more on the Fear of Cancer Recurrence Inventory severity subscale. * 4\) Be at least 18 years of age. * 5\) Be able to read, understand and express herself in French. Exclusion Criteria: * 1\) Have distant metastases (in the case of ovarian cancer, only stages IV and IIIC will be excluded). * 2\) Be known to carry a BRCA1/2 "VUS" mutation. * 3\) Have a known cognitive disorder. * 4\) Have a known severe psychological disorder (e.g., psychotic disorder, bipolar disorder, substance abuse or dependence disorder). * 5\) Have already taken part in the original FCR group psychotherapy at the CHU de Québec. * 6\) Women taking psychotropic medication are eligible, but only if the dosage has been stable for at least one month.
References
Publications (11)
- BACKGROUNDLebel S, Ozakinci G, Humphris G, Mutsaers B, Thewes B, Prins J, Dinkel A, Butow P; University of Ottawa Fear of Cancer Recurrence Colloquium attendees. From normal response to clinical problem: definition and clinical features of fear of cancer recurrence. Support Care Cancer. 2016 Aug;24(8):3265-8. doi: 10.1007/s00520-016-3272-5. Epub 2016 May 12. PMID 27169703
- BACKGROUNDSimard S, Thewes B, Humphris G, Dixon M, Hayden C, Mireskandari S, Ozakinci G. Fear of cancer recurrence in adult cancer survivors: a systematic review of quantitative studies. J Cancer Surviv. 2013 Sep;7(3):300-22. doi: 10.1007/s11764-013-0272-z. Epub 2013 Mar 10. PMID 23475398
- BACKGROUNDBaker F, Denniston M, Smith T, West MM. Adult cancer survivors: how are they faring? Cancer. 2005 Dec 1;104(11 Suppl):2565-76. doi: 10.1002/cncr.21488. PMID 16258929
- BACKGROUNDArmes J, Crowe M, Colbourne L, Morgan H, Murrells T, Oakley C, Palmer N, Ream E, Young A, Richardson A. Patients' supportive care needs beyond the end of cancer treatment: a prospective, longitudinal survey. J Clin Oncol. 2009 Dec 20;27(36):6172-9. doi: 10.1200/JCO.2009.22.5151. Epub 2009 Nov 2. PMID 19884548
- BACKGROUNDSavard J, Ivers H. The evolution of fear of cancer recurrence during the cancer care trajectory and its relationship with cancer characteristics. J Psychosom Res. 2013 Apr;74(4):354-60. doi: 10.1016/j.jpsychores.2012.12.013. Epub 2013 Jan 26. PMID 23497839
- BACKGROUNDSavard J, Filion C, Brearty CM, Caplette-Gingras A, Chiquette J, Dorval M. Fear of cancer recurrence in breast cancer survivors carrying a BRCA1/2 mutation: A qualitative study. Cancer Med. 2024 Jan;13(1):e6889. doi: 10.1002/cam4.6889. Epub 2024 Jan 8. PMID 38192174
- BACKGROUNDChampagne A, Ivers H, Savard J. Utilization of health care services in cancer patients with elevated fear of cancer recurrence. Psychooncology. 2018 Aug;27(8):1958-1964. doi: 10.1002/pon.4748. Epub 2018 Jun 1.