Descriptors and Predictors of Burden and Information Needs

Completed

• Conditions: Symptoms; Advanced Lung Cancer
• Interventions: Other: questionnaires

• Registration Number: NCT04069494
• Lead Sponsor: Chulabhorn Cancer Center

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.

Study Timeline

• Study First Submitted: 2019-08-02
• Study First Submitted QC: 2019-08-23
• Study First Posted: 2019-08-28
• Study Start: 2019-10-01
• Primary Completion: 2020-02-29
• Study Completion: 2020-02-29
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
care giver	questionnaires	Patients' family caregivers will also be invited to participate
patients	questionnaires	People diagnosed with advanced lung cancer and scheduled to receive palliative RT will be invited to participate between 1st July 2019 and 31st January 2020.

Primary Outcome Measures

Name	Time	Method
Changes of symptom experiences	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	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.

Trial Locations

Locations (1)

ChulaBhorn Hospital; 🇹🇭 Bangkok, Thailand