Effects of Forgiveness-Based Group Psychoeducation Applied to Cancer Survivors on Fear of Cancer Recurrence, Forgiveness and Psychiatric Symptoms: 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
- 64
- 试验地点
- 1
- 主要终点
- Heartland Forgiveness Scale
研究概览
简要总结
This study aims to examine the effects of forgiveness-based group psychoeducation applied to cancer survivors on fear of cancer recurrence, forgiveness and psychiatric symptoms.
详细描述
This study was designed as a randomized controlled experimental study with a pre-test-post-test and follow-up design to examine the effects of forgiveness-based group psychoeducation on fear of cancer recurrence, forgiveness and psychiatric symptoms of cancer survivors.
The aim is to evaluate the effects of a forgiveness-based psychoeducation program on cancer survivors. After the "Informed Voluntary Consent Form" is obtained from individuals who agree to participate in the study, the Introductory Information Form, Heartland Forgiveness Scale, Fear of Relapse Inventory and Brief Symptom Inventory will be applied. Pre-tests will be applied to the sample determined by an independent statistician. Then, participants will be divided into intervention and control groups by simple randomization method. Face-to-face forgiveness-based psychoeducation will be applied to the intervention group in 90-minute sessions once/twice a week, totaling 6 sessions. In the last session of psychoeducation, a post-test ("Introductory Information Form", "Heartland Forgiveness Scale", "Fear of Relapse Inventory" and "Brief Symptom Inventory") will be administered to both the intervention and control groups. The first follow-up test of the study will be administered to both the intervention and control groups 1 month after the post-test, and the second follow-up test of the study will be administered 3 months after the post-test. After the completion of the study and the measurements, it is planned to provide forgiveness-based psychoeducation to the participants in the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The process of assigning participants to groups will be carried out by a statistician outside the study using the simple randomization method and will be hidden from the researcher until the application begins. Since the assignment to groups will be made after informed consent is obtained, the participants will be blinded (single blind). In addition, the statistician will also be blinded in order to reduce statistical analysis and reporting bias. Without specifying which group (intervention and control group) the data belong to, they will be coded and transferred to the database (group A, group B), and the data will be analyzed and reported.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written and verbal consent to participate in the study
- •Understanding and speaking Turkish
- •Being over 18 years old
- •Not having any visual, hearing or mental disabilities
- •Having been diagnosed with cancer, treated with curative intent and having completed major treatments (surgery, radiotherapy, chemotherapy) within the last 5 years
排除标准
- •Not volunteering to participate in research
- •Having a visual, hearing or mental disability
- •Agreeing to participate in another psychoeducational program conducted simultaneously with the research
- •Inability to communicate in Turkish
- •Having previously received training in forgiveness and/or coping with fear of relapse
研究组 & 干预措施
Forgiveness-Based Group Psychoeducation
Forgiveness-based group psychoeducation to be conducted with the experimental group is planned as 6 sessions. The sessions are planned to be conducted in 3 groups of 8-10 people. The duration of a session is planned to be approximately 90 minutes. Group psychoeducation with the experimental group will be conducted face-to-face every week. The appropriate day for the sessions will be decided with the members of each group. The same group sessions will be conducted on the same day and time every week.
干预措施: Forgiveness-Based Group Psychoeducation (Other)
No Intervention
After the follow-up tests were completed, it was planned to implement the 6-session forgiveness-based group psychoeducation applied to the intervention group in the same way upon the request of the control group.
结局指标
主要结局
Heartland Forgiveness Scale
时间窗: Baseline, 6 th week, 1st month follow-up, 3rd month follow-up) (Pre-test-post-test follow-up experimental design)
The scale, which evaluates the level of forgiveness and consists of 18 items, consists of three sub-dimensions: "forgiveness of self", "forgiveness of others" and "forgiveness of the situation". The items of the Likert-type scale are evaluated according to a 7-point evaluation scale and the evaluation is answered as "does not reflect me at all" (1 point), "does not reflect me very much" (3 points), "reflects me a little" (5 points) and "reflects me completely" (7 points). Items 2, 4, 6, 7, 9, 11, 13, 15 and 17 in the scale items are scored reversely. The scale is evaluated according to total and sub-scale scores and there is no cut-off score. High scores obtained from each of the sub-dimensions of the scale indicate a high or low level of forgiveness in the relevant sub-dimension. The total forgiveness score is formed by summing the scores of the sub-dimensions of the scale.
次要结局
- Brief Symptom Inventory(Baseline, 6th week, 1st month follow-up, 3rd month follow-up) (Pre-test-post-test follow-up experimental design))
- Fear of Cancer Recurrence Inventory(Baseline, 6th week, 1st month follow-up, 3rd month follow-up) (Pre-test-post-test follow-up experimental design))
- Brief Symptom Inventory(Baseline, 6th week, 1st month follow-up, 3rd month follow-up) (Pre-test-post-test follow-up experimental design))
- Fear of Cancer Recurrence Inventory(Baseline, 6th week, 1st month follow-up, 3rd month follow-up) (Pre-test-post-test follow-up experimental design))
研究者
Hilal Merve Belen
Principal Investigator
Lokman Hekim Üniversitesi