Clinical trial NCT05761093: Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
Official title: A Study to Evaluate Patient and Physician Benefit/ Risk Preferences for Treatment of Metastatic Prostate Cancer (mPC) in Hong Kong: a Discrete Choice Experiment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 306
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300 consecutive patients with metastatic prostate cancer (150 mHSPC and 150 mCRPC) within 5 years will be recruited

Brief summary: The objective of this study is to examine the preference weightings in term of risk/ benefit attributes of treatment in physician and prostate cancer patients from different stages of disease.


Eligibility criteria: Inclusion Criteria:

* aged 18 years or older,
* diagnosis of metastatic prostate cancer within 5 years,
* able to read and write,
* accepting and signing the informed consent

Exclusion Criteria:

* if patients are unable to complete the survey by themselves due to physical or psychological reasons,
* deemed ineligible by treating physicians if patients are unable to complete the survey by themselves due to physical or psychological reasons,
* deemed ineligible by treating physicians

Primary outcomes:
measure: Patient preferences for treatment attributes in prostate cancer from different stages of disease
timeFrame: 15 minutes (Once through survey)
measure: The Preference weighting from Physicians involved in the treatment of prostate cancer in term of risk/benefit attributes of treatment.
timeFrame: 15 minutes (Once through survey)
Secondary outcomes:
measure: To examine the effect of socio-economic status on preference weighing
timeFrame: 15 minutes (Once through survey)
measure: To examine the status of comorbidities on preference weighing
timeFrame: 15 minutes (Once through survey)
measure: To examine their willingness of trading off survival with improving QOL
timeFrame: 15 minutes (Once through survey
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Chi Fai NG, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sartor O, de Bono JS. Metastatic Prostate Cancer. N Engl J Med. 2018 Feb 15;378(7):645-657. doi: 10.1056/NEJMra1701695. Epub 2018 Feb 7. No abstract available.
citation: Feldman-Stewart D, Brundage MD, Van Manen L, Svenson O. Patient-focussed decision-making in early-stage prostate cancer: insights from a cognitively based decision aid. Health Expect. 2004 Jun;7(2):126-41. doi: 10.1111/j.1369-7625.2004.00271.x.
citation: Aning JJ, Wassersug RJ, Goldenberg SL. Patient preference and the impact of decision-making aids on prostate cancer treatment choices and post-intervention regret. Curr Oncol. 2012 Dec;19(Suppl 3):S37-44. doi: 10.3747/co.19.1287.
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citation: Hauber AB, Arellano J, Qian Y, Gonzalez JM, Posner JD, Mohamed AF, Gatta F, Tombal B, Body JJ. Patient preferences for treatments to delay bone metastases. Prostate. 2014 Nov;74(15):1488-97. doi: 10.1002/pros.22865. Epub 2014 Aug 17.
citation: Ryan M, Farrar S. Using conjoint analysis to elicit preferences for health care. BMJ. 2000 Jun 3;320(7248):1530-3. doi: 10.1136/bmj.320.7248.1530. No abstract available.
citation: Fizazi K, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Kappeler C, Snapir A, Sarapohja T, Smith MR; ARAMIS Investigators. Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2019 Mar 28;380(13):1235-1246. doi: 10.1056/NEJMoa1815671. Epub 2019 Feb 14.
citation: Gravis G, Fizazi K, Joly F, Oudard S, Priou F, Esterni B, Latorzeff I, Delva R, Krakowski I, Laguerre B, Rolland F, Theodore C, Deplanque G, Ferrero JM, Pouessel D, Mourey L, Beuzeboc P, Zanetta S, Habibian M, Berdah JF, Dauba J, Baciuchka M, Platini C, Linassier C, Labourey JL, Machiels JP, El Kouri C, Ravaud A, Suc E, Eymard JC, Hasbini A, Bousquet G, Soulie M. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013 Feb;14(2):149-58. doi: 10.1016/S1470-2045(12)70560-0. Epub 2013 Jan 8.