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

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05740800
• Collaborator: (none)
• Enrollment: 184
• Location: 1
• Anticipated Duration (Months): 41.4
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Supportive Care Needs; Immunotherapy

Study Design

• Study Type: Observational
• Actual Enrollment: 184 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• 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
• Actual Study Start Date: Oct 18, 2019
• Actual Primary Completion Date: Oct 18, 2021
• Anticipated Study Completion Date: Mar 31, 2023

Outcome Measures

Primary Outcome Measures

1. Supportive Care Needs Survey [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 Outcome Measures

1. 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.]

   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) .

2. 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.]

   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.

3. 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.]

   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.

4. 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.]

   Patients' immunotherapy side effects will be measured by CTCAE.The severity is divided into 5 grades, the higher the grade, the higher the severity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University	Taipei		Taiwan	802

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT05740800
• Other Study ID Numbers: 201812191RINB
• First Posted: Feb 23, 2023
• Last Update Posted: Feb 23, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Taiwan University Hospital: cancer; caregiver; immune therapy; treatment decision making; care need

Study Results

No Results Posted as of Feb 23, 2023