- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05667571
Symptom Communication in Advanced Cancer
A Mixed-Methods Pilot Study of Symptom Communication in Advanced Cancer: Patterns and Associating Factors
Background Improving patient-provider communication is a fundamental and cost-effective method to advance patient outcomes, including symptom management which is often the primary goal of care for patients with advanced cancer. Unfortunately, some studies revealed the poor quality of symptom communication among cancer patients and healthcare providers. While these evidences suggest important gaps in communication about symptoms with some of the most vulnerable patients, little is known about the patterns and associating factors of symptom communication.
Purpose and Specific Aims The proposed 3-year pilot project aims to provide an enrich and systematic description of symptom communication by validating a newly developed typology of interaction patterns of symptom communication (TIPSC) between patients with advanced cancer, their caregivers, and healthcare providers and explore factors related to each interaction pattern. The specific aims are to: (1) validate TIPSC in Taiwanese advanced cancer population, (2) explore patients' /caregivers' experience and thoughts of symptom discussion in regard to their interaction patterns and symptom management, and (3) examine relationships between interaction patterns and (a) demographic factors, (b) symptom severity, (c) congruence in symptom assessment between patients/caregivers and providers, (d) patients'/caregivers' perceived ability to communicate with providers, and (e) patient/caregiver satisfaction.
Sampling This pilot study plans to recruit about 50 patient/caregiver - oncologist dyads. The recruitment process contains three stages. First, medical oncologists who are currently in clinical practice at participating institutions and care for patients with solid tumors will be approached. Second, participating oncologists' patients will be recruited if they are: (1) currently a patient of a participating oncologist, (2) diagnosed with stage III or IV solid cancer, (3) aged 20 years or older, (4) able to tolerate an interview that will last approximately 30 minus, and (5) able to speak Chinese or Taiwanese. Finally, if applicable, adult caregivers who intent to join selected out-patient-department (OPD) visit with the patients will also be recruited.
Research Design This is a mixed-methods study with a two-phase exploratory sequential design. The first phase is a qualitative descriptive study in which the investigators will record patient/caregiver-oncologist OPD visits and conduct patient/caregiver interviews to address aim 1 and 2. Discourse and conversation analysis will be used to analyze the recorded visits and content analysis will be used to analyze the interviews. The second phase is a correlational study in which the investigators use questionnaires to measure variables and examine their relationship with interaction patterns (aim 3). Descriptive statistics, binomial logistic regression, and linear regression will be used to analyze quantitative data.
Expecting Results This is a pioneering study addressing the patterns and associating factors of symptom communication in Taiwanese patients with advanced cancer. The findings will systematically map out the patient/caregiver-provider symptom communication and identify relationships between communication patterns and meaningful indicators. This proposed study is a critical step to understand patient/caregiver-provider communication regarding symptoms in order to pinpoint symptom management and communication barriers and design proper interventions in Taiwan.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Taipei, Taiwan, 10051
- National Taiwan University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Currently a patient of a participating physician
- Diagnosed with advanced solid cancer (TNM stage III or IV)
- Aged 20 years or older
- Able to tolerate an interview that will last approximately 30 minus
- Able to speak Chinese or Taiwanese.
Exclusion Criteria:
- Do not experience any symptoms
- Are hospitalized at recruitment
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chinese Patients' Satisfaction Scale (C-PSS)
Time Frame: Once, immediately after outpatient visit
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patient satisfaction
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Once, immediately after outpatient visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
European Organization for Research and Treatment of Cancer (EORCT-QLQ C30)
Time Frame: Once, immediately after outpatient visit
|
congruence of symptom management between patients and providers
|
Once, immediately after outpatient visit
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201807052RINC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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