Development and Assessment of the 8-item Chronic Pain Acceptance Questionnaire to Measure Disease Acceptance in Women With Breast Cancer

NCT07328321 | Completed

• 1 other identifier: Protocol No. 53-2023
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Neoplasm; Disease Acceptance; Psychometrics; Questionnaire; Rehabilitation; Psychological Flexibility; Commitment

Outcome Measures

Primary Outcomes (1)

• Structural Validity of the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC)

  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.

  Baseline

Secondary Outcomes (7)

• 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)

Study Arms (1)

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.

Behavioral: Cancer Pathology Acceptance Questionnaire

Interventions

Cancer Pathology Acceptance Questionnaire BEHAVIORAL

A self-reported questionnaire (CPAQ-8-BC) designed to assess two related dimensions of disease acceptance in women with breast cancer: Activity Engagement and Disease Receptivity. The instrument is used to measure psychological flexibility and experimental avoidance in this population.

Women diagnosed with Breast Cancer for Psychometric Evaluation

Eligibility Criteria

• Age: 18 Years - 87 Years
• Gender Eligibility Details: This study is specifically focused on women who have received a diagnosis of Breast Cancer. Participation is limited to individuals who are biologically female, consistent with the typical population affected by this condition.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study participants were consecutively enrolled from two specific inpatient Hospital Breast Units in Italy. The population consists of women attending these units who had received a confirmed histopathological diagnosis of Breast Cancer (BC). The units served as the primary recruitment sites for the study.

You may qualify if:

• Adult age
• Confirmed histopathological diagnosis of Breast Cancer (BC)
• Ability to understand the Italian language

You may not qualify if:

• Documented peripheral or central neurological disorders
• Systemic illnesses
• Cognitive impairment
• Recent myocardial infarction
• Previous cerebrovascular events

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

Simple Departmental Operative Unit - Breast Unit, "Santo Spirito" Hospital of Pescara

Pescara, Pescara, 65124, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Teresa Paolucci, MD, PhD

  Department of Oral, Medical Sciences and Biotechnology (DSMOB), "G. d'Annunzio" University of Chieti-Pescara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 9, 2026
• Study Start: January 13, 2025
• Primary Completion: August 19, 2025
• Study Completion: August 19, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)