Clinical trial NCT05740800: Patient Care Needs and the Decision-Making Experience of Patients With Cancer and Family Caregivers Regarding Immunotherapy: A Qualitative and Quantitative Mixed Methods Study
Official title: Patient Care Needs and the Decision-Making Experience of Patients With Cancer and Family Caregivers Regarding Immunotherapy: A Qualitative and Quantitative Mixed Methods Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Supportive Care Needs
Immunotherapy
Keywords: cancer
caregiver
immune therapy
treatment decision making
care need
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 184
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients and their family caregivers with immunotherapy.

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.


Eligibility criteria: Patient

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with mental illness.
2. Confused and unable to communicate verbally or in writing to complete the research interviews.
3. Those who are reluctant to accept interviews and participate in research surveys.

Family caregivers

Inclusion Criteria:

1. 20 years old and above.
2. Live with the patient and spend the most time caring for the patient.
3. The primary family caregiver is identified by the patient.

Exclusion Criteria:

1. Caregivers with mental illness.

Primary outcomes:
measure: Supportive Care Needs Survey
timeFrame: 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.
Secondary outcomes:
measure: Physical and Psychological Symptoms Scale
timeFrame: 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.
measure: CollaboRATE scale and SURE scale
timeFrame: 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.
measure: Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT)
timeFrame: 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.
measure: Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
timeFrame: 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.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
References: