Cognitive Behavioral Therapy for Fear of Cancer Recurrence in Women With BRCA1/2 Gene

NCT06817694 | Recruiting

• 1 other identifier: 2024-7302
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer Susceptibility Gene (BRCA1) Mutation; BRCA2 Mutation; Fear of Cancer Recurrence

Keywords

BRCA1 Mutation; BRCA 2 Mutation; Fear of cancer recurrence; Cognitive-Behavioral Therapy; Cancer

Outcome Measures

Primary Outcomes (1)

• Fear of cancer recurrence inventory (FCRI)

  The questionnaire includes 38 questions and assess seven aspects associated with fear of cancer recurrence: Triggers, Severity, Psychological Distress, Functioning impairments, Insight, Reassurance and Coping Strategies. Total values vary between 0 and 152. Higher scores indicate a greater fear of recurrence.

  At recruitment, 4 weeks after recruitment, 3 and 6 months post intervention

Secondary Outcomes (12)

• Hospital anxiety and depression scale

  At recruitment, 4 weeks after recruitment, 3 and 6 months post intervention

• Insomnia severity index (ISI)

  At recruitment, 4 weeks after recruitment, 3 and 6 months post intervention

• Fatigue symptom inventory (FSI)

  At recruitment, 4 weeks after recruitment, 3 and 6 months post intervention

• European Organisation for Research and Treatment of cancer's quality of life questionnaire (QLQ-C30)

  At recruitment, 4 weeks after recruitment, 3 and 6 months post intervention

• Revised Illness Perception Questionnaire

  At recruitment, 4 weeks after recruitment, 3 and 6 months post intervention

Study Arms (2)

Immediate intervention

EXPERIMENTAL

This group will start as soon as between 5-8 persons have been recruited and randomized into the immediate intervention group.

Behavioral: Cognitive-behavioral group therapy

Waiting list group

ACTIVE COMPARATOR

This group will wait for 7 weeks after being recruited before starting the same intervention as the immediate intervention group.

Behavioral: Cognitive-behavioral group therapy

Interventions

Cognitive-behavioral group therapy BEHAVIORAL

The intervention consists of a 4-week cognitive-behavioral group therapy. Each session is given online and will last 90-minutes. The intervention has been adapted to the population of women with a cancer and a BRCA1/2 mutation from a behavioral-cognitive therapy for fear of cancer recurrence that already exists and has already been proven effective.

Immediate intervention; Waiting list group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Have completed primary treatment for breast or ovarian cancer (i.e., surgery, chemotherapy, and radiotherapy).
• \) Be known to carry a BRCA1/2 pathogenic mutation.
• \) 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.
• \) Be at least 18 years of age.
• \) Be able to read, understand and express herself in French.

You may not qualify if:

• \) Have distant metastases (in the case of ovarian cancer, only stages IV and IIIC will be excluded).
• \) Be known to carry a BRCA1/2 "VUS" mutation.
• \) Have a known cognitive disorder.
• \) Have a known severe psychological disorder (e.g., psychotic disorder, bipolar disorder, substance abuse or dependence disorder).
• \) Have already taken part in the original FCR group psychotherapy at the CHU de Québec.
• \) Women taking psychotropic medication are eligible, but only if the dosage has been stable for at least one month.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

CHU de Québec-Université Laval

Québec, Quebec, Canada

RECRUITING

Related Publications (11)

• Lebel 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 BACKGROUND

• Simard 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 BACKGROUND

• Baker 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 BACKGROUND

• Armes 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 BACKGROUND

• Savard 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 BACKGROUND

• Savard 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 BACKGROUND

• Champagne 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.

  PMID: 29719072 BACKGROUND

• Butow PN, Turner J, Gilchrist J, Sharpe L, Smith AB, Fardell JE, Tesson S, O'Connell R, Girgis A, Gebski VJ, Asher R, Mihalopoulos C, Bell ML, Zola KG, Beith J, Thewes B. Randomized Trial of ConquerFear: A Novel, Theoretically Based Psychosocial Intervention for Fear of Cancer Recurrence. J Clin Oncol. 2017 Dec 20;35(36):4066-4077. doi: 10.1200/JCO.2017.73.1257. Epub 2017 Nov 2.

  PMID: 29095681 BACKGROUND

• Lebel S, Maheu C, Lefebvre M, Secord S, Courbasson C, Singh M, Jolicoeur L, Benea A, Harris C, Fung MF, Rosberger Z, Catton P. Addressing fear of cancer recurrence among women with cancer: a feasibility and preliminary outcome study. J Cancer Surviv. 2014 Sep;8(3):485-96. doi: 10.1007/s11764-014-0357-3. Epub 2014 Apr 23.

  PMID: 24756313 BACKGROUND

• Smith AB, Costa D, Galica J, Lebel S, Tauber N, van Helmondt SJ, Zachariae R. Spotlight on the Fear of Cancer Recurrence Inventory (FCRI). Psychol Res Behav Manag. 2020 Dec 21;13:1257-1268. doi: 10.2147/PRBM.S231577. eCollection 2020.

  PMID: 33376421 BACKGROUND

• Savard, J., Caplette-Gingras, A., Casault, L., & Hains, J. Treating Fear of Cancer Recurrence with Group Cognitive-behavioral Therapy: A Step-by-step Guide: Springer; 2022.

  BACKGROUND

Related Links

• Humphris, G., \& Rogers, S. (2012). AFTER and beyond: cancer recurrence fears and a test of an intervention in oral and oropharyngeal patients. Social Science and Dentistry, 2(1), 29-38.
• Savard, J., Savard, M.-H., Caplette-Gingras, A., Casault, L., \& Camateros, C. (2018). Development and feasibility of a group cognitive-behavioral therapy for fear of cancer recurrence. Cognitive and Behavioral Practice, 25(2), 275-285.

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Emma Coughlan

CONTACT

418-525-4444; emma.coughlan@crchudequebec.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 10, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

CA (1)