Breast CancerCPAQ-8-BCNCT07328321
Development and Assessment of the 8-item Chronic Pain Acceptance Questionnaire to Measure Disease Acceptance in Women With Breast Cancer
An observational study of Breast Cancer, run by G. d'Annunzio University at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 87 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cancer Pathology Acceptance Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 101 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jan 2025to 19 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 87 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult age
- Confirmed histopathological diagnosis of Breast Cancer (BC)
- Ability to understand the Italian language
Who cannot join
- Documented peripheral or central neurological disorders
- Systemic illnesses
- Cognitive impairment
- Recent myocardial infarction
- Previous cerebrovascular events
Trial locations and contacts
1 site in 1 country.
Italy1 site
Simple Departmental Operative Unit - Breast Unit, "Santo Spirito" Hospital of Pescara
Pescara, Pescara, 65124
About this study
Official title: Development and Preliminary Validation of the Cancer Pathology Acceptance Questionnaire in Women With Breast Cancer
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.
Read the detailed description
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.
Data Collection: Participants filled out the self-administered Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC), which consists of 8 items rated on a scale of 0 (never true) to 6 (always true). A pilot testing phase was conducted to assess the scale's face validity, appropriateness, acceptability, and feasibility.
Psychometric Evaluation Plan
The primary focus of the psychometric testing is to investigate the Structural Validity, Reliability, and Interpretability of the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC):
- Structural Validity: Confirmatory Factor Analysis (CFA) is performed to test a single-factor structure against a pre-hypothesized two-factor structure consisting of Activity Engagement and Disease Receptivity. Model fit is evaluated using the Comparative Fit Index (CFI), Tucker Lewis Index (TLI), Standardized Root Mean Square Residual (SRMR), and Root Mean Square Error of Approximation (RMSEA).
- Reliability: Internal consistency is assessed using Cronbach's alpha and McDonald's omega. Test-Retest Stability is investigated using the Intraclass Correlation Coefficient (ICC2,1) over a 10-15 day period. The Standard Error of Measurement (SEM) is also calculated.
- Interpretability: The Minimum Detectable Change (MDC) is estimated to determine the smallest change in score that can be considered a true change rather than measurement error.
Clinical Relevance The Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC) is intended to serve as a tool for person-oriented evaluations in multidisciplinary rehabilitation settings. Identifying patients with low acceptance levels may help clinicians identify those prone to activity avoidance and poor functional recovery. The instrument is designed to support the tailoring of interventions, such as Acceptance and Commitment Therapy (ACT) or Cognitive-Behavioral Therapy (CBT), by assessing key areas of psychological flexibility.
- Conditions
- Breast Cancer
- Being tested
- Cancer Pathology Acceptance Questionnaire
- Keywords
- Breast Cancer, Neoplasm, Disease Acceptance, Psychometrics, Questionnaire, Rehabilitation, Psychological Flexibility, Commitment
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer Pathology Acceptance QuestionnaireBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cancer Pathology Acceptance Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (7)
Reliability of the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC)
This measure evaluates the consistency and stability of the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC). It includes the assessment of Internal Consistency for each factor (Activity Engagement and Disease Receptivity) and Test-Retest Stability.
- Scale Description: The Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC) is a self-administered questionnaire designed to quantify disease acceptance.
- Scale Scoring: The instrument consists of 8 items, each rated on a scale of 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.
- Interpretation: Higher scores indicate a higher level of disease acceptance.
- Stability Assessment: Test-Retest Stability is calculated using the Intraclass Correlation Coefficient (ICC2,1).
Measured: At enrollment (Baseline) and 10-15 days after surgery
Interpretability of The Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC)
This measure determines the smallest change in the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC) score that can be considered a true change rather than measurement error. This is assessed by calculating the Minimum Detectable Change (MDC) at a 95% confidence level.
- Scale Description: The Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC) is a self-administered questionnaire adapted from the 8-item Chronic Pain Acceptance Questionnaire (CPAQ-8).
- Scale Scoring: 8 items rated on a 7-point scale (0 to 6).
- Minimum and Maximum Values: Total scores range from 0 to 48.
- Interpretation: Higher scores reflect greater disease acceptance. The Minimum Detectable Change (MDC) value provides the threshold for identifying clinically relevant changes in an individual patient's score.
Measured: Through study completion, an average of 15 days
Psychological Inflexibility measured by the Acceptance and Action Questionnaire - II (AAQ-II)
This measure is used to establish the convergent validity of the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC) by assessing its association with the construct of psychological inflexibility (the opposite of psychological flexibility).
- Scale Description: The Acceptance and Action Questionnaire - II (AAQ-II) is a widely used 7-item self-report instrument designed to measure psychological inflexibility and experiential avoidance.
- Scale Scoring: Each item is rated on a 7-point Likert scale ranging from 1 ("never true") to 7 ("always true").
- Minimum and Maximum Values: The total score ranges from a minimum of 7 to a maximum of 49.
- Interpretation: Higher scores on the Acceptance and Action Questionnaire - II (AAQ-II) indicate greater levels of psychological inflexibility.
Measured: At enrollment (Baseline)
Psychological Distress measured by the Depression, Anxiety, and Stress Scale-21 (DASS-21)
This measure is used to evaluate the concurrent validity of the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC) by assessing its association with general levels of psychological distress.
- Scale Description: The Depression, Anxiety, and Stress Scale - 21 (DASS-21) is a 21-item self-report instrument designed to measure the three related negative emotional states of depression, anxiety, and tension/stress.
- Scale Scoring: The scale consists of three subscales (7 items each). Each item is rated on a 4-point Likert scale ranging from 0 ("did not apply to me at all") to 3 ("applied to me very much or most of the time").
- Minimum and Maximum Values: The total score for the Depression, Anxiety, and Stress Scale - 21 (DASS-21) ranges from a minimum of 0 to a maximum of 126 (or 0 to 42 for each subscale if not multiplied.
- Interpretation: Higher scores on the Depression, Anxiety, and Stress Scale-21 (DASS-21) indicate higher levels of psychological distress.
Measured: At enrollment (Baseline)
Catastrophizing thoughts measured by the Pain Catastrophizing Scale (PCS)
This measure is used to evaluate the convergent validity of the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC) by assessing its association with catastrophizing, a maladaptive cognitive-emotional response to illness or pain characterized by magnification, rumination, and helplessness.
- Scale Description: The Pain Catastrophizing Scale (PCS) is a 13-item self-report instrument that measures three dimensions of catastrophizing: rumination, magnification, and helplessness.
- Scale Scoring: Each item is rated on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("all the time").
- Minimum and Maximum Values: The total score ranges from a minimum of 0 to a maximum of 52.
- Interpretation: Higher scores on the Pain Catastrophizing Scale (PCS) indicate higher levels of catastrophizing (a worse outcome).
Measured: 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)
This measure is used to evaluate the concurrent validity of the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC) by assessing its association with the quality of life and physical, psychological, and social functioning of cancer patients.
- Scale Scoring: Most items are rated on a 4-point Likert scale (1 = "not at all" to 4 = "very much"), except for the global health status which uses a 7-point scale. All scores are linearly transformed to a scale of 0 to 100.
- Minimum and Maximum Values: The score for each subscale ranges from a minimum of 0 to a maximum of 100.
Interpretation:
For the Functional scales and the Global Health Status scale, a higher score represents a higher (better) level of functioning or quality of life.
For the Symptom scales and items, a higher score represents a higher (worse) level of symptomatology or problems.
Measured: 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)
This measure is used to evaluate the concurrent validity of the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC) by assessing its association with quality of life issues specifically related to Breast Cancer (BC), such as body image, sexual functioning, and treatment side effects.
Scale Scoring: Items are rated on a 4-point Likert scale (1 = "not at all" to 4 = "very much"). All scores are linearly transformed to a scale of 0 to 100.
Minimum and Maximum Values: The score for each subscale ranges from a minimum of 0 to a maximum of 100.
Interpretation:
For the Functional scales (e.g., Body Image), a higher score represents a higher (better) level of functioning.
For the Symptom scales (e.g., Systemic Therapy Side Effects), a higher score represents a higher (worse) level of symptomatology or distress. It is expected that higher acceptance scores on the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC) will correlate with better functionality
Measured: At enrollment (Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start13 Jan 2025
- Primary completion19 Aug 2025
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Paolucci, G. d'Annunzio University
- Investigators
- Teresa Paolucci, MD, PhD, Principal investigator, Department of Oral, Medical Sciences and Biotechnology (DSMOB), "G. d'Annunzio" University of Chieti-Pescara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328321
- Sponsor's protocol ID
- Protocol No. 53-2023
- Acronym
- CPAQ-8-BC
- Status last verified
- Mar 2026
- First submitted
- 16 Dec 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Preliminary Validation of the Cancer Pathology Acceptance Questionnaire in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT07328321
- Acronym / sponsor ID
- CPAQ-8-BC / Protocol No. 53-2023
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Neoplasm, Disease Acceptance, Psychometrics, Questionnaire, Rehabilitation, Psychological Flexibility, Commitment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Data Collection: Participants filled out the self-administered Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC), which consists of 8 items rated on a scale of 0 (never true) to 6 (always true). A pilot testing phase was conducted to assess the scale's face validity, appropriateness, acceptability, and feasibility.
Psychometric Evaluation Plan
The primary focus of the psychometric testing is to investigate the Structural Validity, Reliability, and Interpretability of the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC):
- Structural Validity: Confirmatory Factor Analysis (CFA) is performed to test a single-factor structure against a pre-hypothesized two-factor structure consisting of Activity Engagement and Disease Receptivity. Model fit is evaluated using the Comparative Fit Index (CFI), Tucker Lewis Index (TLI), Standardized Root Mean Square Residual (SRMR), and Root Mean Square Error of Approximation (RMSEA).
- Reliability: Internal consistency is assessed using Cronbach's alpha and McDonald's omega. Test-Retest Stability is investigated using the Intraclass Correlation Coefficient (ICC2,1) over a 10-15 day period. The Standard Error of Measurement (SEM) is also calculated.
- Interpretability: The Minimum Detectable Change (MDC) is estimated to determine the smallest change in score that can be considered a true change rather than measurement error.
Clinical Relevance The Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC) is intended to serve as a tool for person-oriented evaluations in multidisciplinary rehabilitation settings. Identifying patients with low acceptance levels may help clinicians identify those prone to activity avoidance and poor functional recovery. The instrument is designed to support the tailoring of interventions, such as Acceptance and Commitment Therapy (ACT) or Cognitive-Behavioral Therapy (CBT), by assessing key areas of psychological flexibility.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women diagnosed with Breast Cancer for Psychometric Evaluation | – | Behavioral: Cancer Pathology Acceptance QuestionnaireThis 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. |
Who may qualify
- Ages
- 18 to 87 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adult age
- Confirmed histopathological diagnosis of Breast Cancer (BC)
- Ability to understand the Italian language
Key exclusion criteria (5 listed)
- Documented peripheral or central neurological disorders
- Systemic illnesses
- Cognitive impairment
- Recent myocardial infarction
- Previous cerebrovascular events
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cancer Pathology Acceptance QuestionnaireA 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. | Behavioural | Women diagnosed with Breast Cancer for Psychometric Evaluation |
Primary outcome
Structural Validity of the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC)
Time frame: 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.
7 secondary outcomes
Reliability of the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC)
Time frame: At enrollment (Baseline) and 10-15 days after surgery
Interpretability of The Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC)
Time frame: Through study completion, an average of 15 days
Psychological Inflexibility measured by the Acceptance and Action Questionnaire - II (AAQ-II)
Time frame: At enrollment (Baseline)
Psychological Distress measured by the Depression, Anxiety, and Stress Scale-21 (DASS-21)
Time frame: At enrollment (Baseline)
Catastrophizing thoughts measured by the Pain Catastrophizing Scale (PCS)
Time frame: 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)
Time frame: 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)
Time frame: At enrollment (Baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Paolucci, MD, PhD principal investigator
Department of Oral, Medical Sciences and Biotechnology (DSMOB), "G. d'Annunzio" University of Chieti-Pescara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by G. d'Annunzio University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural Validity of the Cancer Pathology Acceptance Questionnaire for Breast Cancer (CPAQ-8-BC) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.