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临床试验/NCT07042607
NCT07042607已完成不适用

The Role of Dysfunctional Schemas and Acceptance Regarding Chronic Fatigue in Oncology Patients After Treatment

Zuyderland Medisch Centrum1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2023年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
118
试验地点
1
主要终点
Fatigue

研究概览

简要总结

The role of dysfunctional schemas and acceptance regarding chronic fatigue in oncology patients after treatment

This scientific cross-sectional study is at the intersection of medical psychology and oncology and will address the role of dysfunctional schemas and acceptance in the development of fatigue symptoms after treatment for cancer.

详细描述

Cancer is potentially a deadly disease, but early detection and modern available treatments have increased survival rates in recent decades. Increasing attention is being paid to the well-being of survivors. One of the side effects of long-term curative treatment of cancer, is chronic fatigue. Fatigue has a major impact on daily life and thus on the patient's quality of life.

This study deals with patients who still suffer from chronic fatigue 6 months to two years after (intentionally curative) cancer treatment. Defined in English as chronic cancer-related fatigue (CCRF). The role of acceptance and dysfunctional schedules in maintaining chronic fatigue after cancer will be investigated.

The question is whether oncology patients with dysfunctional schedules after treatment are more likely to maintain CCRF than oncology patients in whom these dysfunctional schedules are present to a lesser extent. From the literature, we chose to examine the dysfunctional schema Relentlessly strict standards/extremely high demands. Exploratively, we also examine the dysfunctional schemas Abandonment/Instability and Self-Sacrifice.

If the above schemas are indeed associated with higher levels of CCRF, we then ask what role acceptance of fatigue plays on the aforementioned correlation. We hypothesize that acceptance plays a mediating role in the correlation between dysfunctional schemas and fatigue: Dysfunctional schemas hinder acceptance of fatigue. Next, we hypothesize that the lower the degree of acceptance, the higher the perceived fatigue will be.

In addition to mediation, a moderating role of dysfunctional schemas could also be hypothesized. Therefore, the second hypothesis hypothesizes that there is a negative relationship between acceptance and fatigue, but only when the relevant dysfunctional schemas are present at low levels. When these dysfunctional schemas are present to a high degree, the relationship between acceptance and fatigue changes. Most likely, the dysfunctional schemas reduce the beneficial influence of acceptance.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •All oncology patients (18 up to and including 70 years of age ), at least 6 months to no later than five years after the last curative treatment and have had no other oncology treatment thereafter (except hormone therapy). The type of oncology treatment (chemotherapy, radiotherapy, immunotherapy or hormone therapy) and the type of cancer they have had are diverse. Subjects recruited should have a good command of the Dutch language in connection with optimal reading and answering of the questionnaires.

排除标准

  • •Exclusion criteria for participation are a psychotic disorder and current substance dependence.

结局指标

主要结局

Fatigue

时间窗: Baseline

The Individual Stress Strength Checklist measures subjective fatigue and behavioral aspects related to it. It consists of 20 statements that examine how the respondent has felt over the past two weeks, indicating to what extent the statement applies to him/her. It measures a picture of fatigue that includes fluctuations over time. Four subscales are distinguished. The scoring method is on a 7-point Likert scale. A cut-off point for the total score is 76, indicating problematic fatigue. For the subjective fatigue subcategory, Normal = a score below 27. A score of 27 or higher is an indication of abnormal fatigue. A score of 35 or higher is considered an indication of severe fatigue.

Dysfunctional schema

时间窗: Baseline

The Young Schema Questionnaire-S3 (YSQ-S3) provides insight into dysfunctional schemas that may be underlying patients' psychological problems. The YSQ-S3 consists of 90 items (statements) measuring 18 schemas including the dysfunctional schemas of ruthless standards/excessive demands, self-sacrifice and abandonment. The method of scoring is on a 6-point Likert scale. After taking the YSQ-S3, the average of all scores per scale is calculated for high predictive value. For most schema scales, a mean score of 2.5 or higher usually appears to fall in the clinical range. The cut-off value for Self-sacrifice and Compassionate norms/extreme demands is around a mean of 3. Internal consistency is adequate for all 18 scales: Cronbach's α=0.70

Acceptance

时间窗: Baseline

The Freiburg mindfulness Inventory-Short Form (FMI-SF) is a questionnaire consisting of two subscales: Presence (attention to experiences of the present moment) and Acceptance (an accepting attitude toward experiences). The FMI-SF has the advantage of being a short list of 14 questions that can be applied in a clinical setting. The items can be scored from 1 (rarely) to 4 (almost always). Both the FMI-14 as a whole (Cronbach's α = .85) and the factors Presence (Cronbach's α= .74) have adequate internal consistency, providing support for the reliability of the scale and subscales.

次要结局

未报告次要终点

研究者

发起方
Zuyderland Medisch Centrum
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marianne van der Zijden

drs

Zuyderland Medisch Centrum

研究点 (1)

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