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Completed

NCT Number: NCT04069494

Descriptors and Predictors of Burden and Information Needs

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ChulaBhorn Hospital

Bangkok, 10210, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

Two questionnaires in patients and another two questionnaires in carer.

Primary outcomes

  1. 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)

  2. 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.

Sponsors and collaborators

Lead sponsor

Chulabhorn Cancer Center

Other

Collaborators

  • University of Glasgow

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2019
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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