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CompletedNCT05667571Updated Dec 28, 2022

Symptom Communication in Advanced Cancer

An observational study in Communication, Cancer and Symptom, Behavioral, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-12-28.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
52
Ages
20 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Communication
  • Cancer
  • Symptom, Behavioral

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03

In context

Behavioral Symptoms

90 studies on the registry are indexed under Behavioral Symptoms; 18 are open to participants now.

This study's enrollment of 52 is below the median of 229 across 12 observational studies indexed under Behavioral Symptoms.

Browse Behavioral Symptoms studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Advanced cancer patients

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

Exclusion Criteria:

  • Do not experience any symptoms
  • Are hospitalized at recruitment
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
52 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Chinese Patients' Satisfaction Scale (C-PSS)

    patient satisfaction

    Time frame: Once, immediately after outpatient visit

Secondary outcomes

  1. European Organization for Research and Treatment of Cancer (EORCT-QLQ C30)

    congruence of symptom management between patients and providers

    Time frame: Once, immediately after outpatient visit

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Study locations

1 site
  • National Taiwan University Hospital
    Taipei, 10051, Taiwan
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References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 1, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05667571
Lead sponsor
National Taiwan University Hospital
Collaborators
Ministry of Science and Technology, Taiwan
Responsible party
Sponsor
First posted
Dec 28, 2022
Start date
Jan 9, 2019
Primary completion
Sep 2, 2020
Completion
Sep 2, 2020
Last update
Dec 28, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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