Managing Breast Cancer Treatment: Dyad's Perspectives on Treatment Decision, Financial and Family Burden.

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 .

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer

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 Type: Observational
• Enrollment (Estimated): 224

Contacts and Locations

• Study Contact: Name: Linghsuan Chen; Phone Number: 886-930021676; Email: linghsuan0303@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Linghsuan Chen; Phone Number: 886-930021676; Email: linghsuan0303@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients who have diagnosed breast cancer and their family.

Description

Inclusion Criteria:

• breast cancer

  1. Patients with newly diagnosed or recurrent breast cancer who require chemotherapy or targeted immunotherapy as recommended by their physicians
  2. Age 20 to 70
  3. Within 0.5 to 3 years of newly diagnosed or recurrent breast cancer
  4. Ability to perform housework or wage employment before cancer
  5. Those whose cognitive function is sufficient to read newspaper news and answer questionnaires

• breast cancer family

  1. 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
  2. Patient's self-reported family members who are involved in the patient's physical, social, or medical caregivers with cancer
  3. Age 20 to 65
  4. Able to perform housework or wage workers
  5. Those whose cognitive function is sufficient to read newspaper news and answer questionnaires

Exclusion Criteria:

• breast cancer

  1. Patients who were disabled before suffering from cancer
  2. only undergoing surgery or hormone therapy

• breast cancer family

  1. Persons with physical, mental and social disabilities
  2. Family members who are not involved in the patient's physical, social, or medical care for cancer

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Taipei University of Nursing and Health Sciences
• Investigators: Principal Investigator: Yen-Shen Lu, National Taiwan University Hospital; Principal Investigator: Shiuyu C. LEe, National Taipei University of Nursing and Health Science

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: March 31, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: breast cancer; financial toxicity; Financial and Family Burden
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 202301195RINB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No