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

Immunotherapy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05740800
• Other study ID #: 201812191RINB
• Status: Active, not recruiting
• Start date: October 18, 2019
• Est. completion date: March 31, 2023

Study information

• Verified date: February 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 184
• Est. completion date: March 31, 2023
• Est. primary completion date: October 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immunotherapy
• Supportive Care Needs

Locations

Country	Name	City	State
Taiwan	National Taiwan University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Supportive Care Needs Survey	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.	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	Physical and Psychological Symptoms Scale	Patients' and family caregivers' physical and psychological symptoms will be measured by Physical and Psychological Symptom Scale.It use Numerical Rating Scale(VRS)0-10.It is a 11 Point Likert Scale(e. g. 0 is no pain; 10 is unbearable pain) .	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	CollaboRATE scale and SURE scale	Patients' and family caregivers' decision making process and conflict will be measured by CollaboRATE scale and SURE scale. CollaboRATE scale is a 10-Point Likert Scale (0-9), higher the score, the more effort you pay on this issues. SURE scale which base on Decisional Conflict Scale are 4 items,The question you agree that you can answer "YES" and got 1 point,if you not fit the description you have to answer "NO" and got 0 points,The lower the total score, the greater the decision conflict.	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	Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT)	Patients' financial toxicity will be measured by COST-FACIT. It is a 5-Point Likert Scale (0-4),The higher the score for each question, the more often the problem occurs.	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	Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	Patients' immunotherapy side effects will be measured by CTCAE.The severity is divided into 5 grades, the higher the grade, the higher the severity.	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.