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 Overview
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Brief Summary
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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.

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

Conditions
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Supportive Care Needs, Immunotherapy

Participation Criteria
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Eligibility Criteria
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Patient 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: 1. Caregivers with mental illness.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, caregiver, immune therapy, treatment decision making, care need