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

NCT05740800 | Completed

• 1 other identifier: 201812191RINB
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Supportive Care Needs; Immunotherapy

Keywords

cancer; caregiver; immune therapy; treatment decision making; care need

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

• 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.

• 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.

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients and their family caregivers with immunotherapy.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• \. Caregivers with mental illness.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University

Taipei, 802, Taiwan

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 23, 2023
• Study Start: October 18, 2019
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: July 22, 2024

Record last verified: 2023-02

Locations

TW (1)