NCT05667571

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 28, 2022

Completed
Last Updated

December 28, 2022

Status Verified

September 1, 2018

Enrollment Period

1.6 years

First QC Date

September 27, 2022

Last Update Submit

December 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Chinese Patients' Satisfaction Scale (C-PSS)

    patient satisfaction

    Once, immediately after outpatient visit

Secondary Outcomes (1)

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

    Once, immediately after outpatient visit

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Advanced cancer patients

You may qualify if:

  • 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.

You may not qualify if:

  • Do not experience any symptoms
  • Are hospitalized at recruitment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10051, Taiwan

Location

MeSH Terms

Conditions

CommunicationNeoplasmsBehavioral Symptoms

Condition Hierarchy (Ancestors)

Behavior

Study Design

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

Study Record Dates

First Submitted

September 27, 2022

First Posted

December 28, 2022

Study Start

January 9, 2019

Primary Completion

September 2, 2020

Study Completion

September 2, 2020

Last Updated

December 28, 2022

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations