Prognostic Understanding in ESC (ProgESC Study)
Prognostic Understanding in Patients Receiving Enhanced Supportive Care (ProgESC Study)
2 other identifiers
observational
91
1 country
1
Brief Summary
This study aims to assess how aware patients with advanced cancer are about their prognosis when they are referred to an Enhanced Supportive Care (ESC) service. Further, the study aim to assess the relationship between patients prognostic understanding and their mental health, quality of life, trust in medical professionals as well as their perception of the care they receive. The study will involve adult patients with advanced cancer who are referred to the ESC service at London University College Hospital. Patients who agree to participate will provide consent and answer a questionnaire. The questionnaire will cover their prognostic awareness, psychological symptoms, and quality of life. It takes about 20 minutes to complete and can be done online via RedCap
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2023
CompletedFirst Posted
Study publicly available on registry
October 4, 2023
CompletedStudy Start
First participant enrolled
November 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedJanuary 3, 2025
January 1, 2025
10 months
September 27, 2023
January 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patients' prognostic understanding
Patients' prognostic understanding about their illness assessed through the Prognosis and Treatment Perception Questionnaire. This questionnaire assesses patient beliefs regarding the likelihood of cure, the preference for receiving prognostic information as well as the perceived helpfulness of knowing about prognosis
within 1 week after patient assessment by the Enhanced Supportive Care Team
Secondary Outcomes (1)
Perceived value of prognostic information
within 1 week after patient assessment by the Enhanced Supportive Care Team
Other Outcomes (5)
Symptoms of anxiety
within 1 week after patient assessment by the Enhanced Supportive Care Team
Symptoms of depression
within 1 week after patient assessment by the Enhanced Supportive Care Team
Patients' quality of life
within 1 week after patient assessment by the Enhanced Supportive Care Team
- +2 more other outcomes
Study Arms (1)
Patients with advanced cancer
Patients with advanced cancer that are referred to the Enhanced Supportive Care Team at University College London Hospital
Eligibility Criteria
Population: Consecutive patients with advanced cancer being referred to the Enhanced Supportive Care Team Setting: UCH Macmillan Cancer Centre
You may qualify if:
- All participants aged 18 and older with advanced cancer referred to the ESC team will be eligible for this study.
You may not qualify if:
- Younger than 18 years
- Insufficient English language to complete questionnaires
- cognitive impairment
- Participants who, in the opinion of the member of the ESC team, would not be appropriate to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University College Hospital Macmillan Cancer Centre
London, United Kingdom
Related Publications (28)
Bakitas MA, Tosteson TD, Li Z, Lyons KD, Hull JG, Li Z, Dionne-Odom JN, Frost J, Dragnev KH, Hegel MT, Azuero A, Ahles TA. Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial. J Clin Oncol. 2015 May 1;33(13):1438-45. doi: 10.1200/JCO.2014.58.6362. Epub 2015 Mar 23.
PMID: 25800768BACKGROUNDBakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198.
PMID: 19690306BACKGROUNDChen CH, Kuo SC, Tang ST. Current status of accurate prognostic awareness in advanced/terminally ill cancer patients: Systematic review and meta-regression analysis. Palliat Med. 2017 May;31(5):406-418. doi: 10.1177/0269216316663976. Epub 2016 Aug 4.
PMID: 27492160BACKGROUNDEl-Jawahri A, Traeger L, Park ER, Greer JA, Pirl WF, Lennes IT, Jackson VA, Gallagher ER, Temel JS. Associations among prognostic understanding, quality of life, and mood in patients with advanced cancer. Cancer. 2014 Jan 15;120(2):278-85. doi: 10.1002/cncr.28369. Epub 2013 Oct 10.
PMID: 24122784BACKGROUNDEnzinger AC, Zhang B, Schrag D, Prigerson HG. Outcomes of Prognostic Disclosure: Associations With Prognostic Understanding, Distress, and Relationship With Physician Among Patients With Advanced Cancer. J Clin Oncol. 2015 Nov 10;33(32):3809-16. doi: 10.1200/JCO.2015.61.9239. Epub 2015 Oct 5.
PMID: 26438121BACKGROUNDEpstein AS, Prigerson HG, O'Reilly EM, Maciejewski PK. Discussions of Life Expectancy and Changes in Illness Understanding in Patients With Advanced Cancer. J Clin Oncol. 2016 Jul 10;34(20):2398-403. doi: 10.1200/JCO.2015.63.6696. Epub 2016 May 23.
PMID: 27217454BACKGROUNDFisher K, Seow H, Cohen J, Declercq A, Freeman S, Guthrie DM. Patient characteristics associated with prognostic awareness: a study of a Canadian palliative care population using the InterRAI palliative care instrument. J Pain Symptom Manage. 2015 Apr;49(4):716-25. doi: 10.1016/j.jpainsymman.2014.08.008. Epub 2014 Sep 8.
PMID: 25220047BACKGROUNDGlare PA, Sinclair CT. Palliative medicine review: prognostication. J Palliat Med. 2008 Jan-Feb;11(1):84-103. doi: 10.1089/jpm.2008.9992.
PMID: 18370898BACKGROUNDGreer JA, Pirl WF, Jackson VA, Muzikansky A, Lennes IT, Heist RS, Gallagher ER, Temel JS. Effect of early palliative care on chemotherapy use and end-of-life care in patients with metastatic non-small-cell lung cancer. J Clin Oncol. 2012 Feb 1;30(4):394-400. doi: 10.1200/JCO.2011.35.7996. Epub 2011 Dec 27.
PMID: 22203758BACKGROUNDGroenvold M, Petersen MA, Aaronson NK, Arraras JI, Blazeby JM, Bottomley A, Fayers PM, de Graeff A, Hammerlid E, Kaasa S, Sprangers MA, Bjorner JB; EORTC Quality of Life Group. The development of the EORTC QLQ-C15-PAL: a shortened questionnaire for cancer patients in palliative care. Eur J Cancer. 2006 Jan;42(1):55-64. doi: 10.1016/j.ejca.2005.06.022. Epub 2005 Sep 12.
PMID: 16162404BACKGROUNDHausner D, Tricou C, Mathews J, Wadhwa D, Pope A, Swami N, Hannon B, Rodin G, Krzyzanowska MK, Le LW, Zimmermann C. Timing of Palliative Care Referral Before and After Evidence from Trials Supporting Early Palliative Care. Oncologist. 2021 Apr;26(4):332-340. doi: 10.1002/onco.13625. Epub 2021 Jan 2.
PMID: 33284483BACKGROUNDHui D, Elsayem A, De la Cruz M, Berger A, Zhukovsky DS, Palla S, Evans A, Fadul N, Palmer JL, Bruera E. Availability and integration of palliative care at US cancer centers. JAMA. 2010 Mar 17;303(11):1054-61. doi: 10.1001/jama.2010.258.
PMID: 20233823BACKGROUNDJackson VA, Jacobsen J, Greer JA, Pirl WF, Temel JS, Back AL. The cultivation of prognostic awareness through the provision of early palliative care in the ambulatory setting: a communication guide. J Palliat Med. 2013 Aug;16(8):894-900. doi: 10.1089/jpm.2012.0547. Epub 2013 Jun 20.
PMID: 23786425BACKGROUNDJanssens A, Derijcke S, Galdermans D, Daenen M, Surmont V, De Droogh E, Lefebure A, Saenen E, Vandenbroucke E, Morel AM, Sadowska A, van Meerbeeck JP. Prognostic Understanding and Quality of Life in Patients With Advanced Lung Cancer: A Multicenter Study. Clin Lung Cancer. 2019 May;20(3):e369-e375. doi: 10.1016/j.cllc.2018.11.011. Epub 2018 Dec 13.
PMID: 30635259BACKGROUNDKennedy BM, Rehman M, Johnson WD, Magee MB, Leonard R, Katzmarzyk PT. Healthcare Providers versus Patients' Understanding of Health Beliefs and Values. Patient Exp J. 2017;4(3):29-37.
PMID: 29308429BACKGROUNDKroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.
PMID: 14583691BACKGROUNDKuhne F, Hermann M, Preisler M, Rohrmoser A, Letsch A, Goerling U. Prognostic Awareness in Advanced Disease: A Review Update and Concept Analysis. Front Psychol. 2021 Jun 24;12:629050. doi: 10.3389/fpsyg.2021.629050. eCollection 2021.
PMID: 34248736BACKGROUNDKurita K, Siegler EL, Reid MC, Maciejewski RC, Prigerson HG. It Is Not What You Think: Associations Between Perceived Cognitive and Physical Status and Prognostic Understanding in Patients With Advanced Cancer. J Pain Symptom Manage. 2018 Aug;56(2):259-263. doi: 10.1016/j.jpainsymman.2018.04.016. Epub 2018 May 10.
PMID: 29753102BACKGROUNDLi C, Friedman B, Conwell Y, Fiscella K. Validity of the Patient Health Questionnaire 2 (PHQ-2) in identifying major depression in older people. J Am Geriatr Soc. 2007 Apr;55(4):596-602. doi: 10.1111/j.1532-5415.2007.01103.x.
PMID: 17397440BACKGROUNDMack JW, Fasciano KM, Block SD. Communication About Prognosis With Adolescent and Young Adult Patients With Cancer: Information Needs, Prognostic Awareness, and Outcomes of Disclosure. J Clin Oncol. 2018 Jun 20;36(18):1861-1867. doi: 10.1200/JCO.2018.78.2128. Epub 2018 Apr 23.
PMID: 29683788BACKGROUNDMayer DK, Nasso SF, Earp JA. Defining cancer survivors, their needs, and perspectives on survivorship health care in the USA. Lancet Oncol. 2017 Jan;18(1):e11-e18. doi: 10.1016/S1470-2045(16)30573-3.
PMID: 28049573BACKGROUNDSato T, Soejima K, Fujisawa D, Takeuchi M, Arai D, Nakachi I, Naoki K, Kawada I, Yasuda H, Ishioka K, Nukaga S, Kobayashi K, Masaki K, Inoue T, Hikima K, Nakamura M, Ohgino K, Oyamada Y, Funatsu Y, Terashima T, Miyao N, Sayama K, Saito F, Sakamaki F, Betsuyaku T. Prognostic Understanding at Diagnosis and Associated Factors in Patients with Advanced Lung Cancer and Their Caregivers. Oncologist. 2018 Oct;23(10):1218-1229. doi: 10.1634/theoncologist.2017-0329. Epub 2018 Aug 17.
PMID: 30120158BACKGROUNDShen MJ, Trevino KM, Prigerson HG. The interactive effect of advanced cancer patient and caregiver prognostic understanding on patients' completion of Do Not Resuscitate orders. Psychooncology. 2018 Jul;27(7):1765-1771. doi: 10.1002/pon.4723. Epub 2018 Apr 30.
PMID: 29611241BACKGROUNDShin JA, El-Jawahri A, Parkes A, Schleicher SM, Knight HP, Temel JS. Quality of Life, Mood, and Prognostic Understanding in Patients with Metastatic Breast Cancer. J Palliat Med. 2016 Aug;19(8):863-9. doi: 10.1089/jpm.2016.0027. Epub 2016 Apr 28.
PMID: 27124211BACKGROUNDTang ST, Chang WC, Chen JS, Chou WC, Hsieh CH, Chen CH. Associations of prognostic awareness/acceptance with psychological distress, existential suffering, and quality of life in terminally ill cancer patients' last year of life. Psychooncology. 2016 Apr;25(4):455-62. doi: 10.1002/pon.3943. Epub 2015 Aug 17.
PMID: 26283000BACKGROUNDTang ST, Wen FH, Hsieh CH, Chou WC, Chang WC, Chen JS, Chiang MC. Preferences for Life-Sustaining Treatments and Associations With Accurate Prognostic Awareness and Depressive Symptoms in Terminally Ill Cancer Patients' Last Year of Life. J Pain Symptom Manage. 2016 Jan;51(1):41-51.e1. doi: 10.1016/j.jpainsymman.2015.08.006. Epub 2015 Sep 18.
PMID: 26386187BACKGROUNDThompson GN, Chochinov HM, Wilson KG, McPherson CJ, Chary S, O'Shea FM, Kuhl DR, Fainsinger RL, Gagnon PR, Macmillan KA. Prognostic acceptance and the well-being of patients receiving palliative care for cancer. J Clin Oncol. 2009 Dec 1;27(34):5757-62. doi: 10.1200/JCO.2009.22.9799. Epub 2009 Oct 13.
PMID: 19826116BACKGROUNDZimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A, Moore M, Rydall A, Rodin G, Tannock I, Donner A, Lo C. Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet. 2014 May 17;383(9930):1721-30. doi: 10.1016/S0140-6736(13)62416-2. Epub 2014 Feb 19.
PMID: 24559581BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Stone, Prof
University College, London
- PRINCIPAL INVESTIGATOR
Joanna Sheppard, MD
University College London Hospital
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2023
First Posted
October 4, 2023
Study Start
November 15, 2023
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
January 3, 2025
Record last verified: 2025-01