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临床试验/NCT05963412
NCT05963412已完成不适用

Developing an Online Individual Intervention Program to Make Sense of People's Experiences After a Breast Cancer Diagnosis and Examining Its Effectiveness

Dokuz Eylul University2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2021年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Socio-demographic and Disease-Related Information Form

研究概览

简要总结

The unexpected changes caused by the diagnosis and treatment of breast cancer can lead individuals to question their beliefs, life meanings, and goals, prompting a search for meaning. According to Park and Folkman's (1997) Meaning-Making Model, the process of meaning making functions as a coping mechanism. It helps individuals adapt challenging experiences into their lives, ultimately assisting in their psychological adjustment to stressful situations. Based on this theoretical model, principles from meaning therapy (Wong, 2010), literature reviews, interviews with breast cancer patients, and expert consultation, an 8-week online individual psychological intervention was developed. It was aimed at facilitating the finding of new meanings in the experience of breast cancer and promoting psychological well-being. It includes psycho-educational, cognitive, existential, and behavioral components explicitly focusing on the meaning-making process. This intervention is called the Meaning Centered Coping Program (MCCP). The main purpose of this study was to test whether the MCCP was an effective intervention program for women diagnosed with breast cancer. For this purpose, the study sample consisted of women with stage I, II, and III breast cancer. Then, participants were randomly assigned to the MCCP group and the wait-list control group. A number of reliable and valid measurement tools were used to compare the MCCP group with the waitlist control group and to examine the effect of the program. Compared with the control group, significant improvements were expected in the level of meaning in life, post-traumatic growth, situational meanings, psychological inflexibility, and psychological well-being in the MCCP group.

详细描述

In recent years, there has been a growing discussion about the necessity for mental health services not only to alleviate individuals' psychological distress but also to focus on enhancing the sense of meaning in life. Therefore, the MCCP aimed not only to reduce distressing psychological symptoms but also to facilitate the discovery of new positive meanings in breast cancer and individual's life, despite existing limitations. In this regard, the MCCP has been developed by drawing upon Meaning-Making Model (Park, 2010; Park and Folkman,1997), principles of meaning therapy (Wong, 2010), the literature on meaning, and existing meaning centered psychotherapy approaches. Additionally, considering limitations such as potential program changes, transportation difficulties, and inadequate physical conditions, online interventions offer a reliable alternative that provides numerous advantages for individuals diagnosed with breast cancer. Therefore, the intervention program was implemented online via video conference for women diagnosed with breast cancer in the current study. After the program was developed, a pilot study was conducted. According to the expert's feedback, the final version of MCCP was developed. The primary aim was to test the effectiveness of MCCP among women with breast cancer. The research hypotheses are 1) compared to control grup, MCCP group would show better improvement in meaning in life and PTG scores 2) compared to control grup, MCCP group would show better improvements in situational meaning (i.e. stress appraisal and violations in general meaning) 3) Compared to control group, the MCCP group would report significant decrease in automatic meaning making efforts (i.e. intrusion and avoidance) 4) Compared to control group, the MCCP group would report a significantly higher level of psychological flexibility and lower level of psychological distress.

Before the data collection process, ethical approval was obtained from the Institutional Ethics Committee of Dokuz Eylül University, affiliated with Dokuz Eylül University School of Medicine (Ethics Committee Decision No: 2021/12-39). The study has been announced using social media platforms (Facebook, Twitter, Instagram), oncology associations established to support oncology patients, and referrals from healthcare professionals to reach potential participants. The sample size was determined using the power analysis method. Then, 44 women diagnosed with breast cancer who volunteered to participate in the study were randomly assigned to either the intervention group or the waitlist control group.

The random assignment process was conducted using the website https://www.randomizer.org/. Participants in the MCCP group were assessed thrice: before the intervention, immediately after the intervention, and at the 2-month follow-up. The control group underwent the initial assessment before intervention began and the final assessment took place eight weeks later. After getting verbal and written consent from all participants, a number of measurement tools was applied. The Sociodemographic and Disease-Related Information Form, The Meaning in Life Questionnaire, Posttraumatic Growth Inventory-X, Stress Appraisal Measure, Global Meaning Violations Scale, Impact of Event Scale-Revised Form, Acceptance and Action Scale-II, and Hospital Anxiety and Depression Scale were used. To test the hypotheses of the study, Pearson correlation analysis, 2 (Group) X 2 (Time) repeated measures ANOVA, and one-way repeated measures ANOVA were applied. SPSS 29.0 Package Program for Social Sciences was used for statistical analyses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • i) being between the ages of 18-65 ii) being a woman iii) stage I, II, and III patients iv) having been diagnosed for at least 6 months and at most 3 years v) being able to video-conference using a desktop computer, a laptop, or a tablet

排除标准

  • i) not having any psychiatric diagnosis or currently using psychiatric medication, ii) not currently receiving psychological support, iii) having a history of cancer diagnosis iv) having a diagnosis of advanced stage (Stage IV) breast cancer.

结局指标

主要结局

Socio-demographic and Disease-Related Information Form

时间窗: Baseline (before the intervention program begins)

This form is a questionnaire designed to gather socio-demographic characteristics and information related to the diagnosis of breast cancer from the participants. Socio-demographic questions include the participant's age, educational level, occupation, income level, marital status, the number of children, and health insurance coverage. The questions related to breast cancer include the time since diagnosis, clinical stage of breast cancer, duration of treatment, completed treatment, type of surgical interventions, cancer history and menstrual status.

Change in the Meaning in Life Questionnaire

时间窗: Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up

The Meaning in Life Scale was developed to measure individuals' level of meaning and purpose in life (Steger et al., 2006) The scale consists of a total of ten items and comprises two dimensions: the presence of meaning and the search for meaning. The scale is assessed using a 7 point scale scored from 1 to 7. The Turkish version of The Meaning in Life Questionnaire, adapted by Akin and Taş (2015), was used in this study. Psychometric features of the Turkish version of the scale indicated that it was a valid and reliable measurement tool.

Change in Post-traumatic Growth Inventory-X

时间窗: Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.

The Posttraumatic Growth Inventory (PTGI) is developed to assess positive changes experienced following traumatic life events. In this study, the Posttraumatic Growth Inventory-X (PTGI-X) was used (Tedeschi et al., 2017). The inventory consists of 25 items and is scored on a six-point scale scored from 0 to 5. Higher scores on the inventory indicated higher levels of posttraumatic growth. The Psychometric properties of the inventory are sufficient to measure the level of post-traumatic growth.

次要结局

  • Change in The Stress Appraisal Measure(Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.)
  • Change in Global Meaning Violation Scale(Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.)
  • Change in The Impact of Event Scale-Revised(Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.)
  • Change in Acceptance and Action Questionnaire-II(Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.)
  • Change in The Hospital Anxiety and Depression Scale(Baseline (before the intervention program), post-intervention at 8 week (after the intervention program) and at the 2-month follow-up.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Selva Ülbe

Research Assistant

Dokuz Eylul University

研究点 (2)

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