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CompletedNCT04069494Updated Jul 17, 2020

Descriptors and Predictors of Burden and Information Needs

An observational study in Advanced Lung Cancer and Symptoms, sponsored by Chulabhorn Cancer Center. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-17.

Sponsored by Chulabhorn Cancer Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
112
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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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Conditions studied

  • Advanced Lung Cancer
  • Symptoms

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Keywords

  • symptoms
  • predictor
  • information needs
  • self-management at home
  • palliative radiotherapy
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 112 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Chulabhorn Cancer Center is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
112 participants (actual)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • 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

  • Otherquestionnaires

    Two questionnaires in patients and another two questionnaires in carer.

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What researchers measure

Primary outcomes

  1. Changes of symptom experiences

    Measure by the Thai version of modified version of the Memorial Symptom Assessment Scale (MSAS)

    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.

  2. 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.

    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.

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Study locations

1 site
  • ChulaBhorn Hospital
    Bangkok, 10210, Thailand
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References and documents

Publications

  • Bade BC, Thomas DD, Scott JB, Silvestri GA. Increasing physical activity and exercise in lung cancer: reviewing safety, benefits, and application. J Thorac Oncol. 2015 Jun;10(6):861-71. doi: 10.1097/JTO.0000000000000536. Erratum In: J Thorac Oncol. 2015 Dec;10(12):1712. doi: 10.1097/JTO.0000000000000681. PubMed 25831230 ↗
  • Carnio S, Di Stefano RF, Novello S. Fatigue in lung cancer patients: symptom burden and management of challenges. Lung Cancer (Auckl). 2016 May 9;7:73-82. doi: 10.2147/LCTT.S85334. eCollection 2016. PubMed 28210163 ↗
  • Choi S, Ryu E. Effects of symptom clusters and depression on the quality of life in patients with advanced lung cancer. Eur J Cancer Care (Engl). 2018 Jan;27(1). doi: 10.1111/ecc.12508. Epub 2016 Apr 26. PubMed 27112232 ↗
  • Deshields TL, Potter P, Olsen S, Liu J. The persistence of symptom burden: symptom experience and quality of life of cancer patients across one year. Support Care Cancer. 2014 Apr;22(4):1089-96. doi: 10.1007/s00520-013-2049-3. Epub 2013 Dec 3. PubMed 24292095 ↗
  • Dionne-Odom JN, Hull JG, Martin MY, Lyons KD, Prescott AT, Tosteson T, Li Z, Akyar I, Raju D, Bakitas MA. Associations between advanced cancer patients' survival and family caregiver presence and burden. Cancer Med. 2016 May;5(5):853-62. doi: 10.1002/cam4.653. Epub 2016 Feb 10. PubMed 26860217 ↗
  • Kotronoulas G, Papadopoulou C, Burns-Cunningham K, Simpson M, Maguire R. A systematic review of the supportive care needs of people living with and beyond cancer of the colon and/or rectum. Eur J Oncol Nurs. 2017 Aug;29:60-70. doi: 10.1016/j.ejon.2017.05.004. Epub 2017 May 30. PubMed 28720267 ↗
  • Lee YH, Liao YC, Liao WY, Shun SC, Liu YC, Chan JC, Yu CJ, Yang PC, Lai YH. Anxiety, depression and related factors in family caregivers of newly diagnosed lung cancer patients before first treatment. Psychooncology. 2013 Nov;22(11):2617-23. doi: 10.1002/pon.3328. Epub 2013 Jul 28. PubMed 23893960 ↗
  • Lou VW, Chen EJ, Jian H, Zhou Z, Zhu J, Li G, He Y. Respiratory Symptoms, Sleep, and Quality of Life in Patients With Advanced Lung Cancer. J Pain Symptom Manage. 2017 Feb;53(2):250-256.e1. doi: 10.1016/j.jpainsymman.2016.09.006. Epub 2016 Nov 8. PubMed 27832984 ↗
  • Miaskowski C. Future Directions in Symptom Cluster Research. Semin Oncol Nurs. 2016 Nov;32(4):405-415. doi: 10.1016/j.soncn.2016.08.006. Epub 2016 Oct 21. PubMed 27776833 ↗
  • Morrison EJ, Novotny PJ, Sloan JA, Yang P, Patten CA, Ruddy KJ, Clark MM. Emotional Problems, Quality of Life, and Symptom Burden in Patients With Lung Cancer. Clin Lung Cancer. 2017 Sep;18(5):497-503. doi: 10.1016/j.cllc.2017.02.008. Epub 2017 Mar 2. PubMed 28412094 ↗
  • Rueda JR, Sola I, Pascual A, Subirana Casacuberta M. Non-invasive interventions for improving well-being and quality of life in patients with lung cancer. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD004282. doi: 10.1002/14651858.CD004282.pub3. PubMed 21901689 ↗
  • Schroder C, Engenhart-Cabillic R, Vorwerk H, Schmidt M, Huhnt W, Blank E, Sidow D, Buchali A. Patient's quality of life after high-dose radiation therapy for thoracic carcinomas : Changes over time and influence on clinical outcome. Strahlenther Onkol. 2017 Feb;193(2):132-140. doi: 10.1007/s00066-016-1068-7. Epub 2016 Oct 27. PubMed 27787567 ↗
  • Shallwani SM, Simmonds MJ, Kasymjanova G, Spahija J. Quality of life, symptom status and physical performance in patients with advanced non-small cell lung cancer undergoing chemotherapy: an exploratory analysis of secondary data. Lung Cancer. 2016 Sep;99:69-75. doi: 10.1016/j.lungcan.2016.06.018. Epub 2016 Jun 23. PubMed 27565917 ↗
  • Stapleton SJ, Holden J, Epstein J, Wilkie DJ. A Systematic Review of the Symptom Distress Scale in Advanced Cancer Studies. Cancer Nurs. 2016 Jul-Aug;39(4):E9-E23. doi: 10.1097/NCC.0000000000000292. PubMed 26252436 ↗
  • Sun V, Grant M, Koczywas M, Freeman B, Zachariah F, Fujinami R, Del Ferraro C, Uman G, Ferrell B. Effectiveness of an interdisciplinary palliative care intervention for family caregivers in lung cancer. Cancer. 2015 Oct 15;121(20):3737-45. doi: 10.1002/cncr.29567. Epub 2015 Jul 6. PubMed 26150131 ↗
  • Tan JY, Molassiotis A, Lloyd-Williams M, Yorke J. Burden, emotional distress and quality of life among informal caregivers of lung cancer patients: An exploratory study. Eur J Cancer Care (Engl). 2018 Jan;27(1). doi: 10.1111/ecc.12691. Epub 2017 Apr 18. PubMed 28417550 ↗
  • Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4. PubMed 25651787 ↗
  • Wong ML, Cooper BA, Paul SM, Levine JD, Conley YP, Wright F, Hammer M, Miaskowski C. Differences in Symptom Clusters Identified Using Ratings of Symptom Occurrence vs. Severity in Lung Cancer Patients Receiving Chemotherapy. J Pain Symptom Manage. 2017 Aug;54(2):194-203. doi: 10.1016/j.jpainsymman.2017.04.005. Epub 2017 May 19. PubMed 28533161 ↗
  • Wong ML, Paul SM, Cooper BA, Dunn LB, Hammer MJ, Conley YP, Wright F, Levine JD, Walter LC, Cartwright F, Miaskowski C. Predictors of the multidimensional symptom experience of lung cancer patients receiving chemotherapy. Support Care Cancer. 2017 Jun;25(6):1931-1939. doi: 10.1007/s00520-017-3593-z. Epub 2017 Feb 3. PubMed 28160076 ↗
  • Yorke J, Lloyd-Williams M, Smith J, Blackhall F, Harle A, Warden J, Ellis J, Pilling M, Haines J, Luker K, Molassiotis A. Management of the respiratory distress symptom cluster in lung cancer: a randomised controlled feasibility trial. Support Care Cancer. 2015 Nov;23(11):3373-84. doi: 10.1007/s00520-015-2810-x. Epub 2015 Jun 26. PubMed 26111954 ↗
  • Chindaprasirt J, Limpawattana P, Pakkaratho P, Wirasorn K, Sookprasert A, Kongbunkiat K, Sawanyawisuth K. Burdens among caregivers of older adults with advanced cancer and risk factors. Asian Pac J Cancer Prev. 2014;15(4):1643-8. doi: 10.7314/apjcp.2014.15.4.1643. PubMed 24641382 ↗
  • Korner P, Ehrmann K, Hartmannsgruber J, Metz M, Steigerwald S, Flentje M, van Oorschot B. Patient-reported symptoms during radiotherapy : Clinically relevant symptom burden in patients treated with palliative and curative intent. Strahlenther Onkol. 2017 Jul;193(7):570-577. doi: 10.1007/s00066-017-1146-5. Epub 2017 Jun 1. PubMed 28573475 ↗
  • Mohile SG, Heckler C, Fan L, Mustian K, Jean-Pierre P, Usuki K, Sprod L, Janelsins M, Purnell J, Peppone L, Palesh O, Devine KA, Morrow G. Age-related Differences in Symptoms and Their Interference with Quality of Life in 903 Cancer Patients Undergoing Radiation Therapy. J Geriatr Oncol. 2011 Oct;2(4):225-232. doi: 10.1016/j.jgo.2011.08.002. PubMed 22888384 ↗
  • Reinke LF, Feemster LC, Backhus LM, Gylys-Colwell I, Au DH. Assessment and Management of Symptoms for Outpatients Newly Diagnosed With Lung Cancer. Am J Hosp Palliat Care. 2016 Mar;33(2):178-83. doi: 10.1177/1049909114557635. Epub 2014 Nov 5. PubMed 25376224 ↗
  • Zeng L, Koo K, Zhang L, Jon F, Dennis K, Holden L, Nguyen J, Tsao M, Barnes E, Danjoux C, Sahgal A, Chow E. Fatigue in advanced cancer patients attending an outpatient palliative radiotherapy clinic as screened by the Edmonton Symptom Assessment System. Support Care Cancer. 2012 May;20(5):1037-42. doi: 10.1007/s00520-011-1179-8. Epub 2011 May 4. PubMed 21538097 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04069494
Lead sponsor
Chulabhorn Cancer Center
Collaborators
University of Glasgow
Responsible party
Saengrawee Thanthong (Principal Investigator, Chulabhorn Cancer Center) — Principal investigator
First posted
Aug 28, 2019
Start date
Oct 1, 2019
Primary completion
Feb 29, 2020
Completion
Feb 29, 2020
Last update
Jul 17, 2020

Study contacts

Saengrawee Thanthong
principal investigator · Mrs

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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