Group Positive Psychology-Based Program for Fear of Breast Cancer Recurrence (NCT07657728) | Clinical Trial Compass
CompletedNot Applicable
Group Positive Psychology-Based Program for Fear of Breast Cancer Recurrence
Iran38 participantsStarted 2023-07-01
Plain-language summary
The goal of this clinical trial is to learn whether a group positive psychology-based educational program can reduce fear of cancer recurrence in women with a history of breast cancer who have completed primary treatment (surgery, chemotherapy, and radiotherapy).
The main question it aims to answer is:
Does an 8-week online positive psychology program reduce fear of cancer recurrence scores measured by the Fear of Cancer Recurrence Inventory (FCRI) compared to no intervention? Researchers will compare the intervention group (received 8 weeks of positive psychology training) to the control group (received no intervention during the study period) to see if the positive psychology program significantly reduces fear of cancer recurrence.
Participants will:
Complete online demographic and baseline Fear of Cancer Recurrence Inventory (FCRI) questionnaires (approximately 20 minutes) If assigned to the intervention group: Attend eight weekly 90-minute online positive psychology sessions based on Seligman's model via Skype Complete home exercises between sessions (e.g., recording three good things daily, writing a gratitude letter, practicing savoring techniques) Complete the FCRI questionnaire again immediately after the final intervention session.
If assigned to the control group: Receive no intervention during the study period and complete the FCRI questionnaire at the same time points as the intervention group; offered the same positive psychology training two months after the study ends
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Confirmed diagnosis of breast cancer (stages 1 to 3) by a specialist physician
. Completion of all treatment phases, including surgery, chemotherapy, and radiotherapy
. No documented history of personality or psychological disorders based on medical records
. No current use of psychiatric or sedative medications
. No prior participation in a psychological intervention similar to the one studied
. Married
. Residing in Golestan Province, Iran
. At least elementary school education
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a group positive psychology program to address fear of cancer recurrence — can you explain what positive psychology involves in this context, and whether that kind of approach has been shown to help people in situations like mine?
2The trial measured changes in fear of cancer recurrence scores over 8 weeks — since it's now completed, has any data been published on whether participants actually felt meaningfully less anxious about recurrence by the end of the program?
3Because this was a group-based program, I'd be sharing my experience with other breast cancer survivors — is that something you think would be a good fit for where I am emotionally right now, or might one-on-one support be a better starting point?
4Since this trial is completed and not actively enrolling, are there similar programs or evidence-based therapies for fear of recurrence that I could actually access now, either locally or through our health system?
5Fear of recurrence is something I'm really struggling with — based on what this trial was studying, what do you think the strongest options are for addressing that fear alongside my medical treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Total Fear of Cancer Recurrence Inventory (FCRI) Score at 8 Weeks
Timeframe: Baseline and immediately after the final intervention session (8 weeks from baseline)