Clinical trial NCT04069494: Descriptors and Predictors of Burden and Information Needs
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Lung Cancer
Symptoms
Keywords: symptoms
predictor
information needs
self-management at home
palliative radiotherapy
Lead sponsor: Chulabhorn Cancer Center
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2019-08-28
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People diagnosed with advanced lung cancer and scheduled to receive palliative RT and their carer will be invited to participate between 1st september 2019 and 29 Febuary 2020.

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.

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:

  * 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

Primary outcomes:
measure: Changes of symptom experiences
timeFrame: 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: Changes of information need
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: ChulaBhorn Hospital
Study officials:
affiliation: Mrs
name: Saengrawee Thanthong
role: PRINCIPAL_INVESTIGATOR
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