Descriptors and Predictors of Burden and Information Needs

NCT04069494 | Completed DMC

• 1 other identifier: 200180015
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Lung Cancer; Symptoms

Keywords

symptoms; predictor; information needs; self-management at home; palliative radiotherapy

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (2)

patients

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.

Other: questionnaires

care giver

Patients' family caregivers will also be invited to participate

Other: questionnaires

Interventions

questionnaires OTHER

Two questionnaires in patients and another two questionnaires in carer.

care giver; patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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:
• 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
• Non-English, Non-Thai speaking

Sponsors & Collaborators

• Chulabhorn Cancer Center: lead
• University of Glasgow: collaborator

Study Sites (1)

ChulaBhorn Hospital

Bangkok, 10210, Thailand

Location

Related Publications (25)

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MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Saengrawee Thanthong

  Mrs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 28, 2019
• Study Start: October 1, 2019
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

TH (1)