Cognitive Behavioral Therapy for Fear of Cancer Recurrence in Women With BRCA1/2 Gene
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCHU de Quebec-Universite Laval
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive-behavioral group therapy
BehavioralThe 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.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Immediate interventionExperimental treatment 1 intervention
Group B: Waiting list groupActive comparator 1 intervention
Trial outcomes
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.
Time frame
At recruitment, 4 weeks after recruitment, 3 and 6 months post interventionSecondary outcomes
1
Hospital anxiety and depression scale
Includes a total of 14 questions: 7 for anxiety and 7 for depression. For both aspects, the maximum score possible is 21. A score between 0 and 7 indicates a normal level of symptoms, a score between 8 and 10 indicates a borderline abnormal level of symptoms and a score between 11 and 21 indicates an abnormal level of symptoms.
Time frame
At recruitment, 4 weeks after recruitment, 3 and 6 months post intervention2
Insomnia severity index (ISI)
Includes a total of 7 items. Total score varies between 0 and 28. A score between 0 and 7 indicates no clinically significant insomnia, a score between 8 and 14 indicates subthreshold insomnia, a score between 15 and 21 indicates moderate insomnia (moderate severity) and a score between 22 and 28 indicates clinical insomnia (severe).
Time frame
At recruitment, 4 weeks after recruitment, 3 and 6 months post intervention3
Fatigue symptom inventory (FSI)
Includes a total of 7 items. Total score varies between 0 and 70. Lower scores indicate lower levels of fatigue and higher scores indicate higher levels of fatigue.
Time frame
At recruitment, 4 weeks after recruitment, 3 and 6 months post intervention4
European Organisation for Research and Treatment of cancer's quality of life questionnaire (QLQ-C30)
30-items questionnaire developed to assess the quality of life of all cancer patients. Scores range from 0 to 100. A higher score represents a higher level of functioning or a higher level of symptoms, depending on the items.
Time frame
At recruitment, 4 weeks after recruitment, 3 and 6 months post interventionSponsors and contacts
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Source ClinicalTrials.gov