NCT05917444

Brief 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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

April 12, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

June 23, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

March 31, 2023

Last Update Submit

June 15, 2023

Conditions

Breast Cancer

Keywords

breast cancerfinancial toxicityFinancial and Family Burden

Outcome Measures

Primary Outcomes (6)

  • 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.

    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

    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.

    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.

    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.

    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

    Past a month

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have diagnosed breast cancer and their family.

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsFinancial Stress

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Yen-Shen Lu

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

  • Shiuyu C. LEe

    National Taipei University of Nursing and Health Science

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Linghsuan Chen

CONTACT

886-930021676linghsuan0303@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2023

First Posted

June 23, 2023

Study Start

April 12, 2023

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

June 23, 2023

Record last verified: 2023-03

Locations

TW(1)