Clinical trial NCT05917444: Managing Breast Cancer Treatment: Dyad's Perspectives on Treatment Decision, Financial and Family Burden.
Official title: Managing Breast Cancer Treatment: Dyad's Perspectives on Treatment Decision, Financial and Family Burden.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: breast cancer
financial toxicity
Financial and Family Burden
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taipei University of Nursing and Health Sciences
First posted: 2023-06-23
Enrollment: 224
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have diagnosed breast cancer and their family.

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 .

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.

Eligibility criteria: 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

Primary outcomes:
measure: Chinese version of the short form 36 health survey questionnaire (SF-36)
timeFrame: within the past month
measure: FACT-COST(COmprehensive Score for financial Toxicity)
timeFrame: Past 7 days
measure: M. D. Anderson Symptom Inventory
timeFrame: within 24 hours
measure: Cancer Behavior Inventory-Brief
timeFrame: Past 7 days
measure: Decisional Regret Scale
timeFrame: Past 7 days
measure: Financial and Work ability Index
timeFrame: Past a month
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yen-Shen Lu
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taipei University of Nursing and Health Science
name: Shiuyu C. LEe
role: PRINCIPAL_INVESTIGATOR
References: