Development and Preliminary Validation of the Cancer Pathology Acceptance Questionnaire in Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Structural Validity of the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC)
研究概览
简要总结
This observational study was conducted to develop and test a new self-report questionnaire, the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC), specifically adapted for women diagnosed with Breast Cancer (BC). The primary goal is to evaluate if this new tool is a reliable and valid measure for assessing disease acceptance - defined as the psychological ability to acknowledge and experience cancer-related thoughts, emotions, and physical sensations without excessive avoidance or struggle. The study investigates whether the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC) accurately measures two distinct aspects: the psychological receptivity to the illness (Disease Receptivity) and the commitment to activity engagement despite the disease (Activity Engagement). This short questionnaire is intended for use by healthcare providers and rehabilitation specialists to identify patients who struggle with acceptance, potentially guiding personalized psychological therapies, such as Acceptance and Commitment Therapy (ACT), and improving participation in rehabilitation and overall quality of survivorship.
详细描述
Study Background and Rationale Breast Cancer (BC) remains a major global health challenge that often leads to long-term psychological distress, body image concerns, and fatigue, even after the completion of medical treatment. Disease acceptance has emerged as a key determinant of positive emotional and functional outcomes. Therefore, reliable and valid instruments are necessary to quantify acceptance in the context of Breast Cancer (BC) for both research and clinical practice.
This study addresses the limited availability of disease-specific outcome measures by developing the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC). This instrument is an adaptation of the 8-item Chronic Pain Acceptance Questionnaire (CPAQ-8). The adaptation process involved replacing the words "pain" and "chronic pain" with the terms "tumor" or "disease" to make the instrument context-specific for patients.
Methodology and Participants This is a cross-sectional, observational study approved by the University Ethical Review Committee of Sapienza University of Rome (Protocol No. 53-2023).
Sample Size: A total of 101 women with a confirmed histopathological diagnosis of Breast Cancer (BC) were consecutively enrolled from two inpatient Hospital Breast Units.
Inclusion Criteria: Adult age, confirmed Breast Cancer (BC) diagnosis, and the ability to understand the Italian language.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 87 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult age
- •Confirmed histopathological diagnosis of Breast Cancer (BC)
- •Ability to understand the Italian language
排除标准
- •Documented peripheral or central neurological disorders
- •Systemic illnesses
- •Cognitive impairment
- •Recent myocardial infarction
- •Previous cerebrovascular events
研究组 & 干预措施
Women diagnosed with Breast Cancer for Psychometric Evaluation
This group consists of 101 women with a histologically confirmed diagnosis of Breast Cancer (BC). Participants were consecutively enrolled from two inpatient Hospital Breast Units in Italy. The purpose of this group was to serve as the population for the preliminary validation of the Cancer Pathology Acceptance Questionnaire for BC (CPAQ-8-BC). The group was evaluated in a cross-sectional manner, meaning data was collected at a single point in time.
干预措施: Cancer Pathology Acceptance Questionnaire (Behavioral)
结局指标
主要结局
Structural Validity of the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC)
时间窗: Baseline
This measure assesses the underlying factor structure of the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC). Structural Validity is evaluated using Confirmatory Factor Analysis (CFA) to verify the hypothesized two-factor model consisting of Activity Engagement and Disease Receptivity. Success is defined by achieving predefined model fit indices, including a Comparative Fit Index (CFI) ≥ 0.90, a Tucker Lewis Index (TLI) ≥ 0.90, and a Root Mean Square Error of Approximation (RMSEA) ≤ 0.08. * Scale Description: The Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC) is a self-administered tool consisting of 8 items. * Scale Scoring: Each item is rated on a 7-point Likert scale ranging from 0 ("never true") to 6 ("always true"). * Minimum and Maximum Values: The total score ranges from a minimum of 0 to a maximum of 48. * Intrepretation: Higher scores indicate a higher level of disease acceptance.
次要结局
- Reliability of the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC)(At enrollment (Baseline) and 10-15 days after surgery)
- Interpretability of The Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC)(Through study completion, an average of 15 days)
- Psychological Inflexibility measured by the Acceptance and Action Questionnaire - II (AAQ-II)(At enrollment (Baseline))
- Psychological Distress measured by the Depression, Anxiety, and Stress Scale-21 (DASS-21)(At enrollment (Baseline))
- Catastrophizing thoughts measured by the Pain Catastrophizing Scale (PCS)(At enrollment (Baseline))
- Health-Related Quality of Life measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(At enrollment (Baseline))
- Breast Cancer-Specific Quality of Life measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR23)(At enrollment (Baseline))
研究者
Teresa Paolucci
Principal Investigator, Associate Professor
G. d'Annunzio University