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Clinical Trials/NCT04069494
NCT04069494
Completed
Not Applicable

Descriptors and Predictors of Burden and Information Needs on Symptom Self-management in Thai Patients With Lung Cancer and Their Family Caregivers During Palliative Radiotherapy

Chulabhorn Cancer Center1 site in 1 country112 target enrollmentOctober 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Advanced Lung Cancer
Sponsor
Chulabhorn Cancer Center
Enrollment
112
Locations
1
Primary Endpoint
Changes of symptom experiences
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

the purpose of this study is to investigate over time patients' symptom burden, caregiving burden, and patients and caregivers' need for information on patient symptom self-management at home during palliative radiotherapy(RT) for lung cancer. Repeatedly assessing burden and information needs on symptom self-management at home can help healthcare professionals to design a bespoke service and plan of care for both patients and family caregivers. In addition, I will explore psycho-social and clinical predictors of burden and information needs in patients and caregivers. These predictors can help health professionals to identify patients and caregivers at risk for distress during palliative radiotherapy for lung cancer.

Detailed Description

Eligible patients will be invited to take part in the study via a patient information sheet. They will also be asked to nominate their primary caregiver, who will also be invited to take part in the study. We will give patients and caregivers 24 hours to decide whether they want to take part or not. If they do decide to take part, all research participants will be involved in the study on four consecutive occasions before, during and after their treatment. These four time points will be the following: * before first fraction of RT * 1st week of RT (1st-5th faction) * 2nd week of RT (6th-10th fraction) * 1 month after the last fraction of RT The principal researcher, i.e. Saengrawee Thanthong, will endeavour to collect questionnaires in the hospital. If participants cannot come to the hospital to receive radiotherapy or for their follow up appointment and complete the questionnaire, then the principal researcher will call them and offer to complete the questionnaires over the phone so as to minimise missing data due to attrition.

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
February 29, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chulabhorn Cancer Center
Responsible Party
Principal Investigator
Principal Investigator

Saengrawee Thanthong

Principal Investigator

Chulabhorn Cancer Center

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria for patients:
  • Histological diagnosis of Lung cancer with stage III-IV(TNM)
  • Age: 18 years or over
  • Planning for palliative RT
  • Scheduled to receive up to 10 fractions of palliative radiotherapy (Stevens, Macbeth, Toy, Coles, \& Lester, 2015)
  • Exclusion criteria for patients:
  • Non-English, Non-Thai speaking
  • Diagnosis of severe cognitive or mental illness that affects communication
  • Patients' family caregivers will also be invited to participate as per below:
  • Inclusion criteria for caregivers:

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Changes of symptom experiences

Time Frame: These four time points will be the following: before first fraction of RT, 1st week of RT (1st-5th faction), 2nd week of RT (6th-10th fraction) and 1 month after the last fraction of RT.

Measure by the Thai version of modified version of the Memorial Symptom Assessment Scale (MSAS)

Changes of information need

Time Frame: These four time points will be the following: before first fraction of RT, 1st week of RT (1st-5th faction), 2nd week of RT (6th-10th fraction) and 1 month after the last fraction of RT.

information need on symptom self-management at home measure by The Supportive Care Needs Survey - Patient version (SCNS) (Bonevski et al., 2000\& McElduf et al., 2004) and Partners and Caregivers version (SCNS-P\&C) - Information needs subscale.

Study Sites (1)

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