The Effect of a Positive Psychology-Based Educational Program on Fear of Breast Cancer Recurrence in Women Attending Mirdamad Clinic in Gorgan, Iran: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
研究概览
简要总结
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
详细描述
This study was a parallel-group, randomized controlled trial with a pretest-posttest design, conducted between July and September 2023 at Mirdamad Clinic in Gorgan, Iran. The study aimed to evaluate the effectiveness of a group positive psychology-based educational program on fear of cancer recurrence in women with a history of breast cancer.
Theoretical Framework:
The intervention was grounded in Seligman's positive psychology theory, which emphasizes the cultivation of positive emotions, engagement, relationships, meaning, and accomplishment (PERMA model). The program focused on identifying and using signature character strengths, gratitude, savoring, hope and optimism, post-traumatic growth through expressive writing, forgiveness, and altruism.
Intervention Protocol:
Participants assigned to the intervention group received eight weekly 90-minute online sessions delivered via the Skype application. Each session consisted of 45 minutes dedicated to reviewing homework from the previous session and 45 minutes focused on discussion and practice of new skills. A PDF booklet summarizing session content and home exercises was sent to participants via WhatsApp Messenger after each session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Residing in Golestan Province, Iran
- •At least elementary school education
- •Access to an electronic device (computer, tablet, or smartphone) to participate in online sessions
- •Willing to provide written informed consent
排除标准
- •Diagnosis of metastatic breast cancer
- •Diagnosis of recurrent breast cancer during the study period
- •Current use of alcohol, tobacco, or recreational drugs
- •Participation in yoga or meditation classes prior to the study
- •Hearing or speaking problems that would prevent participation in online sessions
- •Concurrent participation in other psychosocial programs or psychotherapy
- •Absence from more than two intervention sessions (for participants assigned to the intervention group)
研究者
Maryam Ghanbarzade
Master of Science (MSc) in Midwifery Counseling
Golestan University of Medical sciences