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Descriptors and Predictors of Burden and Information Needs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069494
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
Saengrawee Thanthong, 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.

Condition or disease Intervention/treatment
Advanced Lung Cancer Symptoms Other: questionnaires

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 112 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
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
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : February 29, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Group/Cohort Intervention/treatment
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
Two questionnaires in patients and another two questionnaires in carer.

care giver
Patients' family caregivers will also be invited to participate
Other: questionnaires
Two questionnaires in patients and another two questionnaires in carer.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069494


Contacts
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Contact: Saengrawee Thanthong 07843838974 s.thanthong.1@research.gla.ac.uk
Contact: Bridget Johnston, professor +44 0) 141 330 3691 Bridget.Johnston@glasgow.ac.uk

Locations
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Thailand
ChulaBhorn Hospital
Bangkok, Thailand, 10210
Contact: Saengrawee Thanthong, M.N.S    852428949    saengrawee81@gmail.com   
Contact: Bridget Johnston, Professor    +44 0) 141 330 3691    Bridget.Johnston@glasgow.ac.uk   
Sponsors and Collaborators
Chulabhorn Cancer Center
University of Glasgow
Investigators
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Principal Investigator: Saengrawee Thanthong Mrs
Publications of Results:
Other Publications:

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Responsible Party: Saengrawee Thanthong, Principal Investigator, Chulabhorn Cancer Center
ClinicalTrials.gov Identifier: NCT04069494    
Other Study ID Numbers: 200180015
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Saengrawee Thanthong, Chulabhorn Cancer Center:
symptoms
predictor
information needs
self-management at home
palliative radiotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases