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Cited by 250Palliative Care and End-of-Life IssuesPalliative and Oncologic CareStatistical Methods in Clinical Trials

Attrition rates, reasons, and predictive factors in supportive care and palliative oncology clinical trials

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Hui, David, Glitza, Isabella, Chisholm, Gary, Yennu, Sriram, Bruera, Eduardo·2013·Cancer
DOI 10.1002/cncr.27854PMC PMC3568443
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Abstract

BACKGROUND: Attrition is common among supportive care/palliative oncology clinical trials. However, to the authors' knowledge, few studies to date have documented the reasons and predictors for dropout. In the current study, the authors' objective was to determine the rate, reasons, and factors associated with attrition both before reaching the primary endpoint and at the end of the study. METHODS: A review of all prospective interventional supportive care/palliative oncology trials conducted in the Department of Palliative Care and Rehabilitation Medicine at The University of Texas MD Anderson Cancer Center in Houston between 1999 and 2011 was performed. Patient and study characteristics and attrition data were extracted. RESULTS: A total of 1214 patients were included in 18 clinical trials. The median age of the patients was 60 years. Approximately 41% had an Eastern Cooperative Oncology Group performance status of ≥ 3, a median Edmonton Symptom Assessment Scale (ESAS) for fatigue of 7 of 10, and a median ESAS for dyspnea of 2 of 10. The attrition rate was 26% (95% confidence interval [95% CI], 23%‐28%) for the primary endpoint and 44% (95% CI, 41%‐47%) for the end of the study. Common reasons for primary endpoint dropout were symptom burden (21%), patient preference (15%), hospitalization (10%), and death (6%). Primary endpoint attrition was associated with a higher baseline intensity of fatigue (odds ratio [OR], 1.10 per point; P = .01) and a longer study duration ( P = .04). End‐of‐study attrition was associated with higher baseline levels of dyspnea (OR, 1.06; P = .01), fatigue (OR, 1.08; P = .01), Hispanic race (OR, 1.87; P = .002), higher level of education ( P = .02), longer study duration ( P = .01), and outpatient studies ( P = 0.05). CONCLUSIONS: The attrition rate was high in supportive care/palliative oncology clinical trials, and was associated with various patient characteristics and a high baseline symptom burden. These findings have implications for future clinical trial design including eligibility criteria and sample size calculation. Cancer 2013. © 2012 American Cancer Society.

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  • People with advanced cancer have a higher risk of mental health problems, including mood disorders, depressive symptoms, cognitive disorders, anxiety, insomnia, and death ideas.

    “Las personas con cáncer avanzado presentan aún mayor riesgo de presentar problemas de salud mental (8-10) , con prevalencias elevadas de trastornos del estado de ánimo y síntomas depresivos, trastornos cognitivos, ansiedad, insomnio e ideas de muerte (11-13) .”

    From AVANZACT: protocolo e intervención psicoterapéutica en cáncer avanzado basados en Terapia de Aceptación y Compromiso. (2025) · cites this paper as [13]

    In Patients and Methods (Data Collection for Patient Characteristics; page not provided), the paper lists depression, anxiety and sleep among symptoms assessed in patients with advanced cancer. Results (Patient Characteristics; page not provided) describe sleep symptom burden as relatively high. The paper does not establish a higher risk of mental health problems or elevated prevalence of the listed disorders and symptoms, and it does not report death ideation. (LLM, conf=0.82)

    Experimental — accuracy not yet measured

  • In people with advanced cancer, a high rate of treatment rejection and abandonment is common.

    “dado que en personas con cáncer avanzado es habitual una alta tasa de rechazo y abandono del tratamiento (13,48,72)”

    From AVANZACT: protocolo e intervención psicoterapéutica en cáncer avanzado basados en Terapia de Aceptación y Compromiso. (2025) · cites this paper as [13]

    The Methods section identifies the participants as patients with advanced cancer, and the Discussion reports high dropout from supportive and palliative oncology trials, including patients who chose to withdraw. It does not establish a high rate of treatment rejection or abandonment: the measured outcome was withdrawal from a clinical trial, not refusal or discontinuation of treatment. (LLM, conf=0.86)

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Authors
Hui, D., Glitza, I., Chisholm, G., Yennu, S., & Bruera, E.
Affiliations
The University of Texas MD Anderson Cancer Center (US)
Corresponding author
Hui, David
ORCID
Venue
Cancer
Publisher
Wiley
Published
2012-11-06
Volume
119
Issue
5
Pages
1098-1105
ISSN
  • 0008-543X (ISSN-L)
  • 1097-0142
DOI
10.1002/cncr.27854
PMC
PMC3568443
OpenAlex
W2052953863
Cited by
250
References
31
Citations by year
2026: 28 · 2025: 19 · 2024: 22 · 2023: 23 · 2022: 22 · 2021: 35 · 2020: 29 · 2019: 17 · 2018: 11 · 2017: 14 · 2016: 8 · 2015: 7 · 2014: 10 · 2013: 3 · 2012: 1
FWCI
6.48
Type
journal article
Language
en
Open access
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations
  • Cancer (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • National Institutes of Health (5r01ca124481-03, 5r01nr010162-04)
  • National Cancer Institute (R01CA12 4481-01, CA 016672, T32CA009666, R01CA122292, R01 CA124481, P30CA016672)
  • National Institute of Nursing Research (R01NR010162-01A1, R01 NR010162)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Palliative Care and End-of-Life Issues
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Palliative and Oncologic Care
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords
attrition, trial dropout, palliative oncology, predictive factors, fatigue, dyspnea, symptom burden, patient preferences, study duration, Hispanic patients, clinical trial design, sample size determination
MeSH terms
Adult, Aged, Aged, 80 and over, Clinical Trials as Topic, Dyspnea, Fatigue, Female, Hospitalization, Humans, Male, Middle Aged, Neoplasms, Palliative Care, Patient Dropouts, Young Adult

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