Breast CancerNCT05917444
Managing Breast Cancer Treatment: Dyad's Perspectives on Treatment Decision, Financial and Family Burden.
An observational study of Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to understand the financial burden and treatment decisions, based on both of patient's and family's perspectives in breast cancer patients who receive systemic chemotherapy, targeted therapy or immuno-therapy and their family caregivers . Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 224 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Apr 2023to 31 Mar 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have diagnosed breast cancer and their family.
Who may be able to join
- breast cancer
- Patients with newly diagnosed or recurrent breast cancer who require chemotherapy or targeted immunotherapy as recommended by their physicians
- Age 20 to 70
- Within 0.5 to 3 years of newly diagnosed or recurrent breast cancer
- Ability to perform housework or wage employment before cancer
- Those whose cognitive function is sufficient to read newspaper news and answer questionnaires
Show all 12Show fewer
- breast cancer family
- Patient has been 0.5 to 3 years since the first diagnosis or recurrence of breast cancer and the doctor recommends chemotherapy or targeted immunotherapy
- Patient's self-reported family members who are involved in the patient's physical, social, or medical caregivers with cancer
- Age 20 to 65
- Able to perform housework or wage workers
- Those whose cognitive function is sufficient to read newspaper news and answer questionnaires
Who cannot join
- breast cancer
- Patients who were disabled before suffering from cancer
- only undergoing surgery or hormone therapy
- breast cancer family
- Persons with physical, mental and social disabilities
- Family members who are not involved in the patient's physical, social, or medical care for cancer
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Linghsuan Chen, 886-930021676, linghsuan0303@gmail.com
About this study
The purpose of this study is to understand the financial burden and treatment decisions, based on both of patient's and family's perspectives in breast cancer patients who receive systemic chemotherapy, targeted therapy or immuno-therapy and their family caregivers .
Read the detailed description
This study utilizes a cross-sectional survey and qualitative research design. Data collection includes questionnaire surveys and recorded qualitative interviews. A total of 224 patients or family members who meet the criteria will be invited to participate in the study at oncology units and outpatient clinics. Among them, 30 subjects, either patients or family caregivers will be invited to explore their experience on and concerns about financial burden and treatment decision making as facing breast cancer.
- Conditions
- Breast Cancer
- Keywords
- breast cancer, financial toxicity, Financial and Family Burden
- Medical subject headings
- Breast Neoplasms, Financial Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese version of the short form 36 health survey questionnaire (SF-36)
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: within the past month
FACT-COST(COmprehensive Score for financial Toxicity)
instrument that assesses the degree of financial distress experienced by cancer patient,12-item COST-PROM the terms used to describe feelings about financial condition have been numerous, including perceived economic well being,personal financial wellness, financial satisfaction, perceived income adequacy, financial stress, debt stress, economic strain, and economic distress.Using the Likert five-point scale, the scores represent the following: 0 indicates 'completely absent,' 1 indicates 'very few,' 2 indicates 'few,' 3 indicates 'some,' and 4 indicates 'very many.' Higher scores indicate better economic conditions
Measured: Past 7 days
M. D. Anderson Symptom Inventory
The first part of the MDASI consists of 13 single-item measures of symptom intensity, including fatigue, sleep disturbance, pain, drowsiness, poor appetite, nausea, vomiting, shortness of breath, numbness, difficulty remembering, dry mouth, distress, and sadness. Each symptom item is rated on a scale of 0 (not al all) to 10 (as bad as you can imagine). The second part of the MDASI assesses the extent to which symptoms interfere with general activities, mood, normal work, relations with other people, walking, and enjoyment of life. Each of the six interference items is rated on a scale of 0 (does not interfere) to 10 (completely interferes). A symptom severity composite score (average of the 13 symptom items) and an interference composite score (average of the six interference items) were computed.
Measured: within 24 hours
Cancer Behavior Inventory-Brief
12-item measure of self-efficacy for coping, including:(1) Maintenance of Activity and Independence; (2) Coping with Treatment-Related Side Effects; (3) Accepting Cancer/Maintaining Positive Attitude; (4) Seeking and Understanding Medical Information; (5) Affective Regulation; (6) Seeking Support; and (7) Stress Management for Medical Appointments. Likert-type scale that ranged from 1 (not at all confident) to 9 (totally confident), reflecting the degree of confidence the patient has that he or she can perform that particular coping behavior.
Measured: Past 7 days
Decisional Regret Scale
The Decision Regret Scale measures the level of regret that patients have regarding their overall cancer treatment. It consists of five items that assess feelings related to the rightness or wrongness of the decision, the harm caused, and whether they would make the same decision again after surgery. It is scored using a 5-point Likert scale, with higher scores indicating a greater level of regret.
Measured: Past 7 days
Financial and Work ability Index
The self-administered questionnaire consists of 7 items, including aspects such as physical and mental ability, cognitive function, and health status of the worker. The scores of each item are summed up, resulting in a total score ranging from 7 to 49. A higher score indicates better work ability. The work ability is assessed based on the total score
Measured: Past a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start12 Apr 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Responsible party
- Sponsor
- Investigators
- Yen-Shen Lu, Principal investigator, National Taiwan University HospitalShiuyu C. LEe, Principal investigator, National Taipei University of Nursing and Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917444
- Sponsor's protocol ID
- 202301195RINB
- Status last verified
- Mar 2023
- First submitted
- 31 Mar 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Breast Cancer Treatment: Dyad's Perspectives on Treatment Decision, Financial and Family Burden.
- ClinicalTrials.gov ID
- NCT05917444
- Acronym / sponsor ID
- 202301195RINB
- Conditions
- Breast Cancer
- Keywords
- breast cancer, financial toxicity, Financial and Family Burden
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 23 Jun 2023 (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.
The purpose of this study is to understand the financial burden and treatment decisions, based on both of patient's and family's perspectives in breast cancer patients who receive systemic chemotherapy, targeted therapy or immuno-therapy and their family caregivers .
Detailed description
This study utilizes a cross-sectional survey and qualitative research design. Data collection includes questionnaire surveys and recorded qualitative interviews. A total of 224 patients or family members who meet the criteria will be invited to participate in the study at oncology units and outpatient clinics. Among them, 30 subjects, either patients or family caregivers will be invited to explore their experience on and concerns about financial burden and treatment decision making as facing breast cancer.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have diagnosed breast cancer and their family.
Key inclusion criteria (12 listed)
- breast cancer
- breast cancer family
Key exclusion criteria (6 listed)
- breast cancer
- breast cancer family
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chinese version of the short form 36 health survey questionnaire (SF-36)
Time frame: within the past month
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
FACT-COST(COmprehensive Score for financial Toxicity)
Time frame: Past 7 days
instrument that assesses the degree of financial distress experienced by cancer patient,12-item COST-PROM the terms used to describe feelings about financial condition have been numerous, including perceived economic well being,personal financial wellness, financial satisfaction, perceived income adequacy, financial stress, debt stress, economic strain, and economic distress.Using the Likert five-point scale, the scores represent the following: 0 indicates 'completely absent,' 1 indicates 'very few,' 2 indicates 'few,' 3 indicates 'some,' and 4 indicates 'very many.' Higher scores indicate better economic conditions
M. D. Anderson Symptom Inventory
Time frame: within 24 hours
The first part of the MDASI consists of 13 single-item measures of symptom intensity, including fatigue, sleep disturbance, pain, drowsiness, poor appetite, nausea, vomiting, shortness of breath, numbness, difficulty remembering, dry mouth, distress, and sadness. Each symptom item is rated on a scale of 0 (not al all) to 10 (as bad as you can imagine). The second part of the MDASI assesses the extent to which symptoms interfere with general activities, mood, normal work, relations with other people, walking, and enjoyment of life. Each of the six interference items is rated on a scale of 0 (does not interfere) to 10 (completely interferes). A symptom severity composite score (average of the 13 symptom items) and an interference composite score (average of the six interference items) were computed.
Cancer Behavior Inventory-Brief
Time frame: Past 7 days
12-item measure of self-efficacy for coping, including:(1) Maintenance of Activity and Independence; (2) Coping with Treatment-Related Side Effects; (3) Accepting Cancer/Maintaining Positive Attitude; (4) Seeking and Understanding Medical Information; (5) Affective Regulation; (6) Seeking Support; and (7) Stress Management for Medical Appointments. Likert-type scale that ranged from 1 (not at all confident) to 9 (totally confident), reflecting the degree of confidence the patient has that he or she can perform that particular coping behavior.
Decisional Regret Scale
Time frame: Past 7 days
The Decision Regret Scale measures the level of regret that patients have regarding their overall cancer treatment. It consists of five items that assess feelings related to the rightness or wrongness of the decision, the harm caused, and whether they would make the same decision again after surgery. It is scored using a 5-point Likert scale, with higher scores indicating a greater level of regret.
Financial and Work ability Index
Time frame: Past a month
The self-administered questionnaire consists of 7 items, including aspects such as physical and mental ability, cognitive function, and health status of the worker. The scores of each item are summed up, resulting in a total score ranging from 7 to 49. A higher score indicates better work ability. The work ability is assessed based on the total score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
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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.
Yen-Shen Lu principal investigator
National Taiwan University Hospital
Shiuyu C. LEe principal investigator
National Taipei University of Nursing and Health Science
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 National Taiwan University Hospital at 1 site in Taiwan.
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 12 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Jun 2023. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linghsuan Chen (886-930021676, linghsuan0303@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese version of the short form 36 health survey questionnaire (SF-36) (time frame: within the past month). The study lists 6 primary outcomes in all. 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 23 Jun 2023.