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临床试验/NCT05768984
NCT05768984招募中不适用

The Effect of an Empowerment Program on Ruminative Thoughts, Fatigue, and Psychological Resilience of Cancer Survivors

Sinem Ocalan1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
62
试验地点
1
主要终点
Change from Baseline Cancer Fatigue Scale at day 70, and day 160

研究概览

简要总结

This study aims to decrease cancer survivors' intrusive ruminative thoughts and cancer-related fatigue and increase their purposive ruminative thoughts and psychological resilience. In this context, an online (Zoom) 10-session empowerment program based on the literature will be implemented for cancer survivors.

详细描述

From the time they were diagnosed with cancer, individuals struggle with ruminative thoughts about why they have this disease, whether they will get better during the treatment process, whether the disease will recur in the future, and cognitive, physical, and emotional fatigue, the cause of which cannot be fully explained. All these processes continue to negatively affect the lives of cancer survivors during the remission period. Studies show that when cancer survivors manage this stressful process well and learn effective coping methods, they can come out of it by developing their psychological resilience. Therefore, this study aimed to determine the effect of an empowerment program to be applied to cancer survivors' ruminative thoughts, cancer-related fatigue, and psychological resilience.

The hypotheses of this research are:

H 1-1: There is a difference between ruminative thinking scores at the end of the empowerment program applied to individuals with cancer in remission and in the follow-up measurement compared to the pre-program and control groups.

H 1-2: There is a difference between cancer-related fatigue scores at the end of the empowerment program applied to individuals with cancer in remission and in the follow-up measurement compared to the pre-program and control groups.

H 1-3: There is a difference between psychological resilience scores at the end of the empowerment program applied to individuals with cancer in remission and in the follow-up measurement compared to the pre-program and control groups.

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

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteering to participate in the research,
  • Being between the ages of 18-65,
  • To have knowledge of reading and writing in Turkish,
  • Being in remission
  • To have technical equipment (camera, microphone, computer) and usage knowledge to participate in the online group session

排除标准

  • To have received psychological support in the last year

结局指标

主要结局

Change from Baseline Cancer Fatigue Scale at day 70, and day 160

时间窗: day 0, day 70, and day 160

It was developed by Okayama et al. in 2003. Consisting of 15 items, the scale has a 5-point Likert type ranging from 'no' (1) to 'too much' (5). It consists of three sub-dimensions: physical (items 1,2,3,6,9,12,15), emotional (items 5,8,11,14), cognitive (items 4,7,10,13). . The range of scores to be taken from the scale is between 0 and 28 points for the physical subscale, and 0 to 16 points for the emotional and cognitive subscale. Total fatigue is the sum of these subscale scores and the maximum total score is 60. The higher the total score, the more severe the fatigue is considered.

Change from Baseline Event-Related Rumination Inventory at day 70, and day 160

时间窗: day 0, day 70, and day 160

It was developed by Cann et al. (2011). The 20-item scale has subscales to evaluate two forms of rumination, "intrusive" and "deliberate". The first ten items measure intrusive rumination, and the second ten items measure deliberate rumination. Each item in the scale is in a 4-point Likert type and is scored as 0 = never, 3 = often. There is no total score in this scale, but subscale scores reveal rumination scores. Scores on each subscale range from 0 to 30. High scores obtained from each sub-dimension of the scale indicate the existence of a ruminative thought tendency towards the said dimension.

Change from Baseline Connor-Davidson Resilience Scale at day 70, and day 160

时间窗: day 0, day 70, and day 160

It was developed by Connor and Davidson (2003). The 25-item scale is in a 5-point Likert structure as 'not at all true' (0) and 'always true' (4). The scale consists of 3 subscales: 'Perseverance and Personal Efficiency' (15 items), 'Resistance to Negativity' (6 items) and 'Tension to Spirituality' (3 items). The lowest and highest values vary between 0-100, and the higher score obtained from the scale indicates greater psychological resilience.

次要结局

未报告次要终点

研究者

发起方
Sinem Ocalan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sinem Ocalan

Research assistant

Hacettepe University

研究点 (1)

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