Descriptors and Predictors of Burden and Information Needs

Advanced Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04069494
• Other study ID #: 200180015
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: February 29, 2020

Study information

• Verified date: July 2020
• Source: Chulabhorn Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• Family member of the care recipient can be spouse, child, parent, friend etc.

• Age: 18 years or over

• Only one family member if the patient presents with more than one.

• Same person in every time point

• Exclusion criteria for caregivers:

• Non-English, Non-Thai speaking

Related Conditions & MeSH terms

• Advanced Lung Cancer
• Lung Neoplasms
• Symptoms

Intervention

Other:
• questionnaires
Two questionnaires in patients and another two questionnaires in carer.

Locations

Country	Name	City	State
Thailand	ChulaBhorn Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Chulabhorn Cancer Center	University of Glasgow

Country where clinical trial is conducted

Thailand, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of symptom experiences	Measure by the Thai version of modified version of the Memorial Symptom Assessment Scale (MSAS)	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.
Primary	Changes of information need	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.	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.