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Older adult participation in cancer clinical trials: A systematic review of barriers and interventions.
Literature Information
| DOI | 10.3322/caac.21638 |
|---|---|
| PMID | 33002206 |
| Journal | CA: a cancer journal for clinicians |
| Impact Factor | 232.4 |
| JCR Quartile | Q1 |
| Publication Year | 2021 |
| Times Cited | 209 |
| Keywords | clinical trials, older adults, oncology, patient participation, patient selection |
| Literature Type | Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't, Systematic Review |
| ISSN | 0007-9235 |
| Pages | 78-92 |
| Issue | 71(1) |
| Authors | Mina S Sedrak, Rachel A Freedman, Harvey J Cohen, Hyman B Muss, Aminah Jatoi, Heidi D Klepin, Tanya M Wildes, Jennifer G Le-Rademacher, Gretchen G Kimmick, William P Tew, Kevin George, Simran Padam, Jennifer Liu, Andrew R Wong, Andrea Lynch, Benjamin Djulbegovic, Supriya G Mohile, William Dale |
TL;DR
This systematic review highlights the significant underrepresentation of older adults in cancer clinical trials, despite their increasing numbers, due to various barriers and a lack of effective interventions to enhance their participation. The authors call for modifications to the current research infrastructure and propose underused solutions to address the evidence gap in geriatric oncology, emphasizing the need for trials specifically designed for older and frail patients.
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clinical trials · older adults · oncology · patient participation · patient selection
Abstract
Cancer is a disease of aging and, as the world's population ages, the number of older persons with cancer is increasing and will make up a growing share of the oncology population in virtually every country. Despite this, older patients remain vastly underrepresented in research that sets the standards for cancer treatments. Consequently, most of what we know about cancer therapeutics is based on clinical trials conducted in younger, healthier patients, and effective strategies to improve clinical trial participation of older adults with cancer remain sparse. For this systematic review, the authors evaluated published studies regarding barriers to participation and interventions to improve participation of older adults in cancer trials. The quality of the available evidence was low and, despite a literature describing multifaceted barriers, only one intervention study aimed to increase enrollment of older adults in trials. The findings starkly amplify the paucity of evidence-based, effective strategies to improve participation of this underrepresented population in cancer trials. Within these limitations, the authors provide their opinion on how the current cancer research infrastructure must be modified to accommodate the needs of older patients. Several underused solutions are offered to expand clinical trials to include older adults with cancer. However, as currently constructed, these recommendations alone will not solve the evidence gap in geriatric oncology, and efforts are needed to meet older and frail adults where they are by expanding clinical trials designed specifically for this population and leveraging real-world data.
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Primary Questions Addressed
- What specific barriers do older adults face when considering participation in cancer clinical trials, and how do these barriers differ from those experienced by younger populations?
- What are some innovative interventions that have been proposed or implemented to enhance the enrollment of older adults in cancer clinical trials?
- How can the design of clinical trials be modified to better accommodate the unique needs and preferences of older cancer patients?
- In what ways can real-world data be leveraged to improve the representation of older adults in cancer research and trials?
- What role do healthcare providers play in influencing older adults' decisions to participate in clinical trials, and how can their involvement be optimized?
Key Findings
Research Background and Purpose
Cancer prevalence increases with age, leading to a growing population of older adults diagnosed with cancer. Despite this demographic shift, older patients are significantly underrepresented in cancer research, particularly in clinical trials that inform treatment standards. The purpose of this systematic review is to assess the barriers to participation of older adults in cancer trials and to evaluate interventions aimed at improving their enrollment.
Main Methods/Materials/Experimental Design
The authors conducted a systematic review of existing literature to identify barriers to participation and interventions targeting older adults in cancer clinical trials. The following steps were involved in their methodology:
- Literature Search: Comprehensive searches of databases to find relevant studies.
- Barrier Identification: Evaluation of the multifaceted barriers preventing older adults from participating in clinical trials.
- Intervention Analysis: Review of studies that tested interventions aimed at increasing enrollment.
- Quality Assessment: Assessment of the quality of evidence available in the literature regarding barriers and interventions.
Key Results and Findings
- The literature identified numerous barriers to participation for older adults, including:
- Health status and comorbidities
- Lack of awareness or understanding of clinical trials
- Transportation and mobility issues
- Caregiver availability
- Only one intervention study was found that specifically aimed to increase the enrollment of older adults in cancer trials.
- The overall quality of evidence regarding barriers and interventions was deemed low.
Main Conclusions/Significance/Innovation
The findings highlight a significant gap in effective, evidence-based strategies to improve the participation of older adults in cancer clinical trials. The authors emphasize the need for a reformed cancer research infrastructure that is more accommodating to the needs of older patients. Proposed solutions include:
- Expanding eligibility criteria for trials to include older patients.
- Utilizing real-world data to better understand the treatment outcomes in older populations.
- Enhancing outreach and education about clinical trials tailored to older adults.
Research Limitations and Future Directions
- Limitations: The systematic review revealed a lack of high-quality studies and a single intervention, indicating a need for more robust research in this area.
- Future Directions:
- Develop and implement targeted interventions to address identified barriers.
- Conduct further studies to establish effective strategies for recruiting older adults into clinical trials.
- Explore innovative trial designs that can incorporate older and frail populations more effectively.
| Aspect | Summary |
|---|---|
| Research Gap | Underrepresentation of older adults in cancer trials |
| Barriers Identified | Health status, awareness, transportation, caregiver issues |
| Intervention Studies | Only one study aimed at increasing enrollment |
| Quality of Evidence | Overall low quality of studies |
| Recommendations | Modify trial designs, use real-world data, enhance outreach |
This review underscores the urgent need to address the challenges faced by older adults in cancer research, aiming to create a more inclusive and representative clinical trial landscape.
References
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Literatures Citing This Work
- Association of Age at Cancer Diagnosis and Clinical Trial Participation. - Jessica Keim-Malpass;Héctor E Alcalá - JAMA network open (2021)
- Different Impact of Definitions of Sarcopenia in Defining Frailty Status in a Population of Older Women with Early Breast Cancer. - Andrea Bellieni;Domenico Fusco;Alejandro Martin Sanchez;Gianluca Franceschini;Beatrice Di Capua;Elena Allocca;Enrico Di Stasio;Fabio Marazzi;Luca Tagliaferri;Riccardo Masetti;Roberto Bernabei;Giuseppe Ferdinando Colloca - Journal of personalized medicine (2021)
- Age Is Just a Number: Considerations for Older Adults in Cancer Clinical Trials. - Dany Habr;Lynn McRoy;Vassiliki A Papadimitrakopoulou - Journal of the National Cancer Institute (2021)
- Racial and socioeconomic disparities in lung cancer screening in the United States: A systematic review. - Ernesto Sosa;Gail D'Souza;Aamna Akhtar;Melissa Sur;Kyra Love;Jeanette Duffels;Dan J Raz;Jae Y Kim;Virginia Sun;Loretta Erhunmwunsee - CA: a cancer journal for clinicians (2021)
- Understanding Treatment Tolerability in Older Adults With Cancer. - Marie A Flannery;Eva Culakova;Beverly E Canin;Luke Peppone;Erika Ramsdale;Supriya G Mohile - Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2021)
- Decision Making in Older Adults With Cancer. - Clark DuMontier;Kah Poh Loh;Enrique Soto-Perez-de-Celis;William Dale - Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2021)
- Immunotherapy in Older Adults With Cancer. - Carolyn J Presley;Fabio Gomes;Christin E Burd;Ravindran Kanesvaran;Melisa L Wong - Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2021)
- Survivorship Care of Older Adults With Cancer: Priority Areas for Clinical Practice, Training, Research, and Policy. - Erin E Kent;Eliza M Park;William A Wood;Ashley Leak Bryant;Michelle A Mollica - Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2021)
- Models of Care in Geriatric Oncology. - Andrew E Chapman;Rawad Elias;Elana Plotkin;Lisa M Lowenstein;Kristine Swartz - Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2021)
- Development and validation of a prediction model for 1-year mortality among older adults with Hodgkin Lymphoma who receive dose-intense chemotherapy. - Anita J Kumar;Jason Nelson;Angie Mae Rodday;Andrew M Evens;Jonathan W Friedberg;Tanya M Wildes;Susan K Parsons - Journal of geriatric oncology (2021)
... (199 more literatures)
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