NCT06067087

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

January 3, 2025

Status Verified

January 1, 2025

Enrollment Period

10 months

First QC Date

September 27, 2023

Last Update Submit

January 2, 2025

Conditions

Keywords

Prognostic understandingEnhanced Supportive Care TeamQuality of lifeAnxietyDepressionSatisfaction

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Related Publications (28)

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    PMID: 22203758BACKGROUND
  • Groenvold 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: 16162404BACKGROUND
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    PMID: 33284483BACKGROUND
  • Hui 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: 20233823BACKGROUND
  • Jackson 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: 23786425BACKGROUND
  • Janssens 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: 30635259BACKGROUND
  • Kennedy 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: 29308429BACKGROUND
  • Kroenke 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: 14583691BACKGROUND
  • Kuhne 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: 34248736BACKGROUND
  • Kurita 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: 29753102BACKGROUND
  • Li 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: 17397440BACKGROUND
  • Mack 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: 29683788BACKGROUND
  • Mayer 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: 28049573BACKGROUND
  • Sato 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: 30120158BACKGROUND
  • Shen 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: 29611241BACKGROUND
  • Shin 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: 27124211BACKGROUND
  • Tang 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: 26283000BACKGROUND
  • Tang 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: 26386187BACKGROUND
  • Thompson 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: 19826116BACKGROUND
  • Zimmermann 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

Anxiety DisordersDepressionPersonal Satisfaction

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Patrick Stone, Prof

    University College, London

    PRINCIPAL INVESTIGATOR
  • Joanna Sheppard, MD

    University College London Hospital

    PRINCIPAL INVESTIGATOR

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

Locations