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

February 20, 2023 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

184

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 802
        • National Taiwan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cancer patients and their family caregivers with immunotherapy.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Supportive Care Needs Survey
Time Frame: 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.
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
Time Frame: 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) .
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
Time Frame: 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.
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)
Time Frame: 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.
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
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2019

Primary Completion (Actual)

October 18, 2021

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Estimate)

February 23, 2023

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201812191RINB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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