Patient Care Needs and the Decision-Making Experience of Patients With Cancer and Family Caregivers Regarding Immunotherapy: A Qualitative and Quantitative Mixed Methods Study

National Taiwan University Hospital1 site in 1 country184 target enrollmentOctober 18, 2019

ConditionsSupportive Care Needs Immunotherapy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Supportive Care Needs
Sponsor: National Taiwan University Hospital
Enrollment: 184
Locations: 1
Primary Endpoint: Supportive Care Needs Survey
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Immunotherapy is currently a crucial cancer treatment option. Despite the development of new cancer treatment, patients and their family caregivers still experience complex psychological feelings and challenges about the effectiveness of immunotherapy, financial burden, and treatment related side effects which reflect the problems related to decision-making and the supportive care needs.

Registry

clinicaltrials.gov

Start Date

October 18, 2019

End Date

November 22, 2022

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

National Taiwan University Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•20 years old and above.
•Patients diagnosed with cancer by a physician.
•The patient has a known condition and has received immunotherapy.
•Those who have received at least 1 time immunotherapy, including: receiving a single drug or immunotherapy combined with other treatment.

Exclusion Criteria

•Patients with mental illness.
•Confused and unable to communicate verbally or in writing to complete the research interviews.
•Those who are reluctant to accept interviews and participate in research surveys.
•Family caregivers
•Inclusion Criteria:
•20 years old and above.
•Live with the patient and spend the most time caring for the patient.
•The primary family caregiver is identified by the patient.
•Exclusion Criteria:
•Caregivers with mental illness.

Outcomes

Primary Outcomes

Supportive Care Needs Survey

Time Frame: 1 time points: From date of approaching patient until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.

Patients' and family caregivers' supportive care needs will be measured by Supportive Care Needs Survey(SCNS) .It is a 5-Point Likert Scale,higher scores mean more care needs.

Secondary Outcomes

CollaboRATE scale and SURE scale(1 time points: From date of approaching patient until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.)
Physical and Psychological Symptoms Scale(1 time points: From date of approaching patient until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.)
Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT)(1 time points: From date of approaching patient until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.)
Common Terminology Criteria for Adverse Events (CTCAE) version 5.0(1 time points: From date of approaching patient until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.)