Advanced Lung CancerNCT04069494
Descriptors and Predictors of Burden and Information Needs
An observational study of Advanced Lung Cancer and Symptoms, run by Chulabhorn Cancer Center at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lung Cancer, Symptoms
- What is being tested?
- questionnaires
- How many people
- 112 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2019to 29 Feb 2020
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- Non-English, Non-Thai speaking
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Advanced Lung Cancer, Symptoms
- Being tested
- questionnaires
- Keywords
- symptoms, predictor, information needs, self-management at home, palliative radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
Two questionnaires in patients and another two questionnaires in carer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: questionnaires | |
| care giver | Patients' family caregivers will also be invited to participate Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of symptom experiences
Measure by the Thai version of modified version of the Memorial Symptom Assessment Scale (MSAS)
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Oct 2019
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Advanced Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Chulabhorn Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Principal investigator, Saengrawee Thanthong, Chulabhorn Cancer Center
- Investigators
- Saengrawee Thanthong, Principal investigator, Mrs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069494
- Sponsor's protocol ID
- 200180015
- Status last verified
- Jul 2020
- First submitted
- 2 Aug 2019
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 25831230Carnio 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 28210163Choi 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 27112232Deshields 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 24292095Dionne-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 26860217Kotronoulas 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 28720267Lee 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 23893960Lou 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 27832984Miaskowski 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 27776833Morrison 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 28412094Rueda 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 21901689Schroder 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 27787567Shallwani 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 27565917Stapleton 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 26252436Sun 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04069494
- Acronym / sponsor ID
- 200180015
- Conditions
- Advanced Lung Cancer, Symptoms
- Keywords
- symptoms, predictor, information needs, self-management at home, palliative radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Chulabhorn Cancer CenterUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | – | Other: questionnairesPeople diagnosed with advanced lung cancer and scheduled to receive palliative RT will be invited to participate between 1st July 2019 and 31st January 2020. |
| care giver | – | Other: questionnairesPatients' family caregivers will also be invited to participate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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)
- Non-English, Non-Thai speaking
Key exclusion criteria (1 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesTwo questionnaires in patients and another two questionnaires in carer. | Other | care giver, patients |
Primary outcome
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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Background: PubMed 25831230Bade 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.
- Background: PubMed 28210163Carnio 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.
- Background: PubMed 27112232Choi 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.
- Background: PubMed 24292095Deshields 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.
- Background: PubMed 26860217Dionne-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.
- Background: PubMed 28720267Kotronoulas 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.
- Background: PubMed 23893960Lee 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.
- Background: PubMed 27832984Lou 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.
- Background: PubMed 27776833Miaskowski 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.
- Background: PubMed 28412094Morrison 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.
- Background: PubMed 21901689Rueda 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.
- Background: PubMed 27787567Schroder 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.
- Individual participant dataSharing planned: Undecided
Related trials for Advanced Lung Cancer
RecruitingObservational study
Real-World Outcomes of Sevabertinib in HER2-Mutant Advanced NSCLC: A Bidirectional Cohort Study
HER2-mutant Advanced Non-Small Cell Lung Cancer
RecruitingPhase 1/2
A 2-part Phase 1/2 Open-label Trial on ODM-212
Mesothelioma, Pancreatic Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 3
A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)
Non-small Cell Lung Cancer (NSCLC)
Recruiting
Multi-site Trial of a Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer
Advanced Lung Cancer, Dyspnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saengrawee Thanthong principal investigator
Mrs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Lung Cancer and Symptoms, run by Chulabhorn Cancer Center at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04069494, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.