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Knowledge, Attitude, and Perception of Clinical Trials among Cancer Patients in India: A Single-Center Cross-Sectional Study
CC BY 4.0 · Indian J Med Paediatr Oncol 2026; 47(04): 311-320
DOI: DOI: 10.1055/s-0046-1824463
Abstract
Introduction
Cancer is the leading cause of death globally and its incidence keeps increasing annually. Clinical trials (CTs) hold massive prospects to benefit patients, optimize treatment strategies, and improve evidence-based medical practice.
Objectives
To assess the present levels of knowledge, attitude, and perception of CTs among cancer patients.
Materials and Methods
A cross-sectional study was conducted in the tertiary care center among cancer patients using a standardized self-administered questionnaire consisting of the domains—demographics, knowledge, attitude, and perception.
Results
A total of 679 cancer patients were invited to participate in the survey. Of these, 375 (n = 375) answered “yes” to the screening question and went on to complete the remaining 15 questions, which evaluated their knowledge, attitudes, and perceptions of CTs. This resulted in a final sample size of 375 participants, reflecting that 55.2% had an understanding of CTs. A total of 311 (82.9%) patients recognized that CT participation is voluntary. Additionally, 307 (81.9%) participants were open to the idea of engaging in CT if required in the future, whereas 290 (77.3%) were apprehensive of the potential risks that may be associated with the CT.
Conclusion
The study provides valuable insights into the factors that affect the understanding of CTs among cancer patients and highlights the positive attitude and perception, while significant gaps remain in awareness and actual participation, along with the understanding of the ethical conduct of CTs. Targeted educational initiatives, physician involvement, community-based advocacy, and culturally focused communication strategies are essential to bridge these gaps.
Patient Consent
Written informed consent was obtained.
Publication History
Article published online:
17 June 2026
© 2026. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)
Thieme Medical and Scientific Publishers Private Limited
A-13A, Graphix Tower 1, 6th floor, Sector 62, Noida 201309, Uttar Pradesh, India
Abstract
Introduction
Cancer is the leading cause of death globally and its incidence keeps increasing annually. Clinical trials (CTs) hold massive prospects to benefit patients, optimize treatment strategies, and improve evidence-based medical practice.
Objectives
To assess the present levels of knowledge, attitude, and perception of CTs among cancer patients.
Materials and Methods
A cross-sectional study was conducted in the tertiary care center among cancer patients using a standardized self-administered questionnaire consisting of the domains—demographics, knowledge, attitude, and perception.
Results
A total of 679 cancer patients were invited to participate in the survey. Of these, 375 (n = 375) answered “yes” to the screening question and went on to complete the remaining 15 questions, which evaluated their knowledge, attitudes, and perceptions of CTs. This resulted in a final sample size of 375 participants, reflecting that 55.2%. had an understanding of CTs. A total of 311 (82.9%) patients recognized that CT participation is voluntary. Additionally, 307 (81.9%) participants were open to the idea of engaging in CT if required in the future, whereas 290 (77.3%) were apprehensive of the potential risks that may be associated with the CT.
Conclusion
The study provides valuable insights into the factors that affect the understanding of CTs among cancer patients and highlights the positive attitude and perception, while significant gaps remain in awareness and actual participation, along with the understanding of the ethical conduct of CTs. Targeted educational initiatives, physician involvement, community-based advocacy, and culturally focused communication strategies are essential to bridge these gaps.
Keywords
clinical trial - attitude - awareness - knowledge - cancer patients - trial participation
Introduction
Cancer is the leading cause of death globally, and its incidence keeps increasing annually. In 2022, it was estimated that over half of all cases (49.23%) and the majority of cancer deaths worldwide (56.2%) will occur in Asia, home to 59.2%. of the world's population. According to GLOBOCAN (a database for global cancer burden), India ranks third for cancer incidence in 2020, behind China and the United States. Moreover, it also projected a 57.5%. increase between 2020 and 2040. The disproportionately greater cancer mortality burden compared to the corresponding incidence burden in Asian and African countries indicates the late stage of diagnosis.[1] Enrollment in a clinical trial (CT) is recommended for all eligible cancer patients who are either progressing or for whom there are no alternatives to standard-of-care treatment, as CTs are regarded as the pinnacle of research methodology when assessing the safety and efficacy of health care interventions. CT holds massive prospects to benefit patients, optimize treatment strategies, and improve evidence-based medical practice.[2] [3] The National Comprehensive Cancer Network states that “clinical research is the best treatment for any cancer patient.”[4] [5] Over the past decade, India has emerged as one of the main hubs for the conduct of clinical research.[6] As per the Clinical Trial Registry of India (CTRI) database as of May 5, 2024, 66,777 trials have been registered. However, the effectiveness of these trials heavily relies on the active participation and comprehension of the enrolled patients, as CT participants are the key to contributing to the researcher's knowledge regarding cancer and also help in the development of cancer treatment options.[7] [8] Poor enrollment in CT results not only in the delay of trial completion but also hampers the approval of more effective novel treatments for cancer patients. Various factors affect the patient's knowledge, attitude, and perception about CTs, which eventually affect the patient's recruitment and retention in CTs, and this, being the critical step in determining the success of CT, has also become the most challenging aspect of CT in recent times.[9] [10] [11] [12] Therefore, the present study aims to address the knowledge, attitude, and perception of CT among cancer patients; this could potentially be of value to oncologists to recruit and retain participants in CTs, improve patient education strategies, thereby enhancing the efficacy of CTs.
Materials and Methods
Study Design
The single-center cross-sectional study was conducted at a tertiary care center in the southern region of India, between August 2024 and October 2024. The Institutional Ethics Committee granted ethical approval. Written informed consent was obtained from cancer patients who met the inclusion and exclusion criteria and were invited to participate in the study. The study focused on Indian patients aged 18 to 80 years who had been diagnosed with cancer and had received either medical or surgical intervention or supportive care for cancer for at least 3 months and were clinically capable of completing the survey. The patients with known psychiatric illnesses, those who declined to participate, as well as individuals currently enrolled in a CT or who had completed a trial, were excluded from the study.
Questionnaire
A standardized self-administered questionnaire was developed with input from experts in their field and based on extensive literature reviews of similar questionnaires. The questionnaire was developed in English and later translated into Tamil and Telugu by bilingual experts. The questionnaire was administered in the participant's preferred language (English/Tamil/Telugu) and was given adequate time to answer, after the investigators explained the contents of the questionnaire. Any of the study team members will verbally read out the questionnaire to assist the illiterate participants in completing it. The questionnaire consists of four parts, of which the first contains the patient's demographic details such as age, gender, locality, education, occupation, and their diagnosis and the year of diagnosis. The next three sections of the questionnaire each consist of five questions on the domains of knowledge (K1–K5), attitude (A1–A5), and perception (P1–P5), along with an initial screening question, resulting in a total of 16 questions. If the response is “no” to the screening question, the subsequent questions become inapplicable. The questions were formatted as Yes or No, so participants indicated their responses by ticking the corresponding boxes.
Inclusion and Exclusion Criteria
Inclusion criteria include male or female cancer patients, aged between 18 and 80 years, diagnosed with any cancer and have received either medical or surgical intervention or supportive care for cancer for at least 3 months, and at any stage of cancer disease with any comorbidities.
Exclusion criteria include pediatric patients (age less than 18 years), patients with any known psychiatric illnesses, patients currently enrolled in or end of trial patients in one or more CTs of any phase approved by the Institute Ethics Committee (IEC), Cancer Institute (WIA), and participants withdrawn from the study based on the principal investigator or coinvestigator's discretion.
Primary and Secondary Outcome
The primary outcome is to elicit the participant's willingness to participate in a CT and advocate it to others and the secondary outcome is to assess the knowledge, attitude, and perception of CTs among cancer patients and to evaluate the factors that positively influenced the patient's willingness to partake in CTs and the barriers to participation.
Results
Statistical Analysis
The statistical analysis was primarily descriptive, with the results presented as percentages. A chi-square test was used to assess the relationship between the participants' knowledge, attitude, and perception with the categorical variants (age, gender, education, locality, and cancer diagnosis). It was not statistically significant, as p < 0.05 were considered statistically significant.
Ethical Approval
The study was approved by the Institutional Ethics Committee, Cancer Institute, WIA, with the study reference number IEC/2024/July 11 on July 26, 2024. All our study procedures adhered to the Declaration of Helsinki.
Results
The screening question asked was: “Do you understand what CTs (research studies) are?” Over the 3-month study period, 679 cancer patients were invited to participate in the survey. Of these, 375 (n = 375) answered “yes” to the screening question and went on to complete the remaining 15 questions, which evaluated their knowledge, attitudes, and perceptions of CTs. This resulted in a final sample size of 375 participants, reflecting that 55.2% had an understanding of CTs. Of 375 participants, the majority filled the questionnaire in Tamil (363), followed by English (10) and Telugu (3).
The median age of the study population was found to be 49 years (range: 18–80) with the interquartile range of 16 years, ranging from Q1 = 41 to Q3 = 57 years. There were 239 (63.73%) females and 136 (36.27%) males. It was found that 170 (45.3%) belonged to the urban population. Most of the study population had a school education—elementary school 130 (34.67%), secondary school 84 (22.4%), and high school 61 (16.27%). They were followed by 71 (18.9%) undergraduates and 27 (7.2%) postgraduates and above ([Table 1]).
A total of 304 (44.8%) of the participants had answered “no” to the screening question. Within this group, a higher proportion were elderly (48%), females (70.1%), and individuals from rural areas (70.4%), indicating potential disparities in awareness and access to information regarding clinical research.
Overall, 301 (80.3%) participants were aware of the potential benefits a CT could offer, and 288 (76.8%) knew that CTs had protocols to ensure patient safety. However, only 293 (63.7%) participants were aware of the ethics committee that governs and monitors CT and safeguards participants' welfare and rights, while 311 (82.9%) patients recognized that CT participation is voluntary ([Table 2]).
The participant's attitude regarding CT was mostly positive, nearly 371 (98.9%) believed CT contributes to medical achievements and 363 (96.8%) thought that the government should support CT and research through the provision of resources and awareness initiatives. Additionally, 307 (81.9%) participants were open to the idea of engaging in CT if required in the future, whereas 290 (77.3%) were apprehensive of the potential risks that may be associated with the CT ([Table 2]).
A total of 335 (89.3%) expressed that they would recommend their family/friends to participate in CT if suggested by the health care provider, signifying the importance of the role of the physician in CT advocacy. Only 236 (62.9%) had encountered CT through media resources, such as newspapers/magazines or other online platforms, and merely 95 (25.3%) had sought CT for their condition, suggesting the need for more widespread dissemination of information on clinical research by using multimedia resources. Only 25.3%. personally sought CTs, while a high proportion of participants reported familiarity with CT participation, which reflects perceived or indirect awareness, indicating a gap between awareness and true engagement ([Table 2]).
The chi-square test was used to assess the relationship between the participant's knowledge, attitude, and perception with categorical variants (age, gender, education, locality, and cancer diagnosis). It was not statistically significant, as p < 0.05 were considered statistically significant ([Tables 3] [4] [5] [6] [7]).
Discussion
The study was intended to assess the knowledge, attitude, and perception of CTs among cancer patients in a single tertiary care center in India. The study results reveal valuable perspectives on how cancer patients regard and comprehend CTs and research.
The findings exhibit encouraging levels of awareness and positivity toward CT, although a gap exists in the understanding of the role of the ethics committee and informed consent protocols, which need to be bridged.
A total of 301 (80.3%) were aware of the potential benefits of CT in our study, comparable to the 85.9% as per the study by Al-Tannir et al, conducted in Saudi Arabia.[13] Similarly, 311 (82.9%) participants acknowledged that participation in CT should be voluntary, which closely aligns with the 72.4%. reported by Al Tannir et al and is further supported by the study by Biswkarma et al of Delhi, where 94.72%. participants agreed that prior to the CT enrollment, the patient's willingness must be sought, emphasizing the voluntary participation in a CT.[14] Regarding the knowledge of the informed consent process in our study, it was around 297 (80%) participants, closely reflecting the finding of 76%. by Biswkarma et al. Al-Tannir et al reported that the knowledge regarding essential elements of informed consent ranges from 55.7 to 85.7%. But the knowledge regarding the placement of protocols to ensure patient safety and the presence of the ethics committee to monitor the research process and to protect patients in CTs was comparatively less, with 288 (76%) and 239 (63.7%), respectively, and this is crucial for ethical understanding and the trust in the governance. This is similar across different populations, as 48.7 and 79%. of the participants believed that CTs are conducted ethically as per Al-Tannir et al and Balasubramanian et al, respectively.[13] [14] [15] With the COVID-19 pandemic catalyzing a global shift in public interest in medical research and CT leading to an improved visibility and accreditation, including in the low- and middle-income countries, it is important to address this issue to promote recruitment and retention in the CT.[16] [17] As earlier literatures suggest with the understanding of the safety of trials significantly increases the patient's willingness to take part in a trial. The knowledge gap regarding the regulatory and ethical domains reflecting improved regulatory transparency highlights the need for improved patient education strategies as recommended by Pandey et al in their review of the CTRI, which plays a critical role in promoting accountability and patient safety.[4] [5]
The participant's attitude toward CT was generally positive, with the majority believing that it would contribute to medical advancements, potentially benefit the patient's health, and highlight the necessity for the government to encourage, support, and provide resources toward medical research/CTs. Despite the favorable outlook, 290 (77.3%) also believe that potential risk may be associated with CT. Several studies largely reflect this.
Factors facilitating include perceived personal health benefits, altruism, financial incentives, trust in physicians, understanding of CT, and motivation and effective engagement of the participants. Conversely, the barriers include mistrust in trial organizations, concerns regarding the efficacy and safety of investigational treatment, apprehension about loss of confidentiality, logistical challenges and dependence on others, as well as language limitations and psychological hesitations.[18] These underscore the cognitive, sociocultural, and emotional factors that play a role in deciding the willingness of the patient's participation in CTs, highlighting the need for culturally sensitive, trust-building, and participant-centered recruitment strategies.
Nevertheless, 307 (81%) participants were willing to participate in future CT, expressing high enrollment opportunities if appropriate information is made available, as only 95 (25%) had sought CT for their own condition, reflecting the gap between positive attitude and personal action, as noted by previous studies where many patients expressed interest in clinical research but was deterred by limited opportunities, knowledge, and resources.[8] [10] Therefore, with appropriate physician guidance, clear communication, and culturally tailored patient education, we could translate these positive attitudes into greater CT participation.
Almost 112 (70%) participants had discussed CTs with their physicians, highlighting the importance of clinician-initiated conversations, which aligns with the study by Sateren et al emphasizing that higher accrual is associated with health care providers support and institutional encouragement.[11] A total of 236 (62%) patients had encountered medical research via media exposure, such as newspapers/magazines/internet, indicating community exposure through mass media, which can further be utilized to clarify misconceptions regarding clinical research and to raise awareness, as well as harness it as a motivational tool to enhance recruitment.[18]
Additionally, peer influence has also emerged as a pivotal factor to promote trust and support openness toward clinical research. Prior studies suggest that peer networks and shared experiences can enhance confidence and acceptance of trial participation.[18] This underscores the potential of community-driven strategies such as patient testimonials and peer advocacy to complement institutional efforts for better recruitment, retention, and engagement for the participants.
The study gives valuable insights into the understanding of CTs using a structured questionnaire (including regional language), and a larger sample size could be beneficial for future considerations of factors that could contribute to or impede the planning, development, and implementation of CTs in the cohort of oncology patients, and also to improve the strategies to curb the barriers for CT enrollment and retention. The key limitation of the study is that confining the analysis to participants who responded yes to the screening question may have led to selection bias, potentially overestimating the participants knowledge, attitude, and willingness toward CT and also the questionnaire was tested among a small group of patients to assess clarity, informally; however, no formal pilot testing was performed. It is a cross-sectional design, henceforth subject to bias, as well as being single-center, the findings could not be generalized to other regions or health care settings.
Conclusion
The study provides valuable insights into the factors that affect the knowledge, attitude, and understanding of CTs among cancer patients, as there are limited data regarding this in India and highlights the positive attitude and perception, while significant gaps remain in awareness and actual participation, along with the understanding of the ethical conduct of CTs. Targeted educational initiatives, physician involvement, community-based advocacy, and culturally focused communication strategies are essential to bridge these gaps and to enhance CT enrollment and ensure ethical and effective clinical research to promote the platform of clinical research in the field of oncology in India, to contribute to further advancements.
References
- Bray F, Laversanne M, Sung H. et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2024; 74 (03) 229-263
- Croke JM, El-Sayed S. Multidisciplinary management of cancer patients: chasing a shadow or real value? An overview of the literature. Curr Oncol 2012; 19 (04) e232-e238
- Comis RL, Miller JD, Aldigé CR, Krebs L, Stoval E. Public attitudes toward participation in cancer clinical trials. J Clin Oncol 2003; 21 (05) 830-835
- Pandey A, Aggarwal A, Seth S, Maulik M, Bano R, Juneja A. Clinical Trials Registry–India: redefining the conduct of clinical trials. Indian J Cancer 2008; 45 (03) 79-82
- Ellis PM, Butow PN, Tattersall MH, Dunn SM, Houssami N. Randomized clinical trials in oncology: understanding and attitudes predict willingness to participate. J Clin Oncol 2001; 19 (15) 3554-3561
- Poongothai S, Unnikrishnan R, Balasubramanian J, Nair MD, Mohan V. Why are clinical trials necessary in India?. Perspect Clin Res 2014; 5 (02) 55-59
- Gillies K, Cotton SC, Brehaut JC, Politi MC, Skea Z. Decision aids for people considering taking part in clinical trials. Cochrane Database Syst Rev 2015; 2015 (11) CD009736
- Ahaghotu C, Tyler R, Sartor O. African American Participation in Oncology Clinical Trials–focus on prostate cancer: implications, barriers, and potential solutions. Clin Genitourin Cancer 2016; 14 (02) 105-116
- Robinson BN, Newman AF, Wallington SF, Swain SM. Focus on you: cancer clinical trials perspectives. Contemp Clin Trials Commun 2016; 4: 170-178
- Linden HM, Reisch LM, Hart Jr A. et al. Attitudes toward participation in breast cancer randomized clinical trials in the African American community: a focus group study. Cancer Nurs 2007; 30 (04) 261-269
- Sateren WB, Trimble EL, Abrams J. et al. How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. J Clin Oncol 2002; 20 (08) 2109-2117
- Mc Grath-Lone L, Day S, Schoenborn C, Ward H. Exploring research participation among cancer patients: analysis of a national survey and an in-depth interview study. BMC Cancer 2015; 15: 618
- Al-Tannir MA, El-Bakri N, Abu-Shaheen AK. Knowledge, attitudes and perceptions of Saudis towards participating in clinical trials. PLoS One 2016; 11 (02) e0143893
- Biswkarma VK, Rohatgi N, Saxena R, Gupta SK. Knowledge, attitudes, and perception of 398 cancer patients toward participation in clinical trials: a single-center study from New Delhi, India. Perspect Clin Res 2022; 13 (01) 43-47
- Balasubramanian J, Rukmani A, Rajesh Kumar R, Purushothaman K. A questionnaire based survey on awareness of clinical trials among general population. Int J Allied Med Sci Clin R 2020; 1 (01) 8-17
- Park JJH, Mogg R, Smith GE. et al. How COVID-19 has fundamentally changed clinical research in global health. Lancet Glob Health 2021; 9 (05) e711-e720
- Alqahtani AM, Almazrou SH, Alalweet RM, Almalki ZS, Alqahtani BF, AlGhamdi S. Impact of COVID-19 on public knowledge and attitudes toward participating in clinical trials in Saudi Arabia: a cross-sectional study. Int J Gen Med 2021; 14: 3405-3413
- Shah JY, Phadtare A, Rajgor D. et al. What leads Indians to participate in clinical trials? A meta-analysis of qualitative studies. PLoS One 2010; 5 (05) e10730
Address for correspondence
Publication History
Article published online:
17 June 2026
© 2026. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)
Thieme Medical and Scientific Publishers Private Limited
A-13A, Graphix Tower 1, 6th floor, Sector 62, Noida 201309, Uttar Pradesh, India
References
- Bray F, Laversanne M, Sung H. et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2024; 74 (03) 229-263
- Croke JM, El-Sayed S. Multidisciplinary management of cancer patients: chasing a shadow or real value? An overview of the literature. Curr Oncol 2012; 19 (04) e232-e238
- Comis RL, Miller JD, Aldigé CR, Krebs L, Stoval E. Public attitudes toward participation in cancer clinical trials. J Clin Oncol 2003; 21 (05) 830-835
- Pandey A, Aggarwal A, Seth S, Maulik M, Bano R, Juneja A. Clinical Trials Registry–India: redefining the conduct of clinical trials. Indian J Cancer 2008; 45 (03) 79-82
- Ellis PM, Butow PN, Tattersall MH, Dunn SM, Houssami N. Randomized clinical trials in oncology: understanding and attitudes predict willingness to participate. J Clin Oncol 2001; 19 (15) 3554-3561
- Poongothai S, Unnikrishnan R, Balasubramanian J, Nair MD, Mohan V. Why are clinical trials necessary in India?. Perspect Clin Res 2014; 5 (02) 55-59
- Gillies K, Cotton SC, Brehaut JC, Politi MC, Skea Z. Decision aids for people considering taking part in clinical trials. Cochrane Database Syst Rev 2015; 2015 (11) CD009736
- Ahaghotu C, Tyler R, Sartor O. African American Participation in Oncology Clinical Trials–focus on prostate cancer: implications, barriers, and potential solutions. Clin Genitourin Cancer 2016; 14 (02) 105-116
- Robinson BN, Newman AF, Wallington SF, Swain SM. Focus on you: cancer clinical trials perspectives. Contemp Clin Trials Commun 2016; 4: 170-178
- Linden HM, Reisch LM, Hart Jr A. et al. Attitudes toward participation in breast cancer randomized clinical trials in the African American community: a focus group study. Cancer Nurs 2007; 30 (04) 261-269
- Sateren WB, Trimble EL, Abrams J. et al. How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. J Clin Oncol 2002; 20 (08) 2109-2117
- Mc Grath-Lone L, Day S, Schoenborn C, Ward H. Exploring research participation among cancer patients: analysis of a national survey and an in-depth interview study. BMC Cancer 2015; 15: 618
- Al-Tannir MA, El-Bakri N, Abu-Shaheen AK. Knowledge, attitudes and perceptions of Saudis towards participating in clinical trials. PLoS One 2016; 11 (02) e0143893
- Biswkarma VK, Rohatgi N, Saxena R, Gupta SK. Knowledge, attitudes, and perception of 398 cancer patients toward participation in clinical trials: a single-center study from New Delhi, India. Perspect Clin Res 2022; 13 (01) 43-47
- Balasubramanian J, Rukmani A, Rajesh Kumar R, Purushothaman K. A questionnaire based survey on awareness of clinical trials among general population. Int J Allied Med Sci Clin R 2020; 1 (01) 8-17
- Park JJH, Mogg R, Smith GE. et al. How COVID-19 has fundamentally changed clinical research in global health. Lancet Glob Health 2021; 9 (05) e711-e720
- Alqahtani AM, Almazrou SH, Alalweet RM, Almalki ZS, Alqahtani BF, AlGhamdi S. Impact of COVID-19 on public knowledge and attitudes toward participating in clinical trials in Saudi Arabia: a cross-sectional study. Int J Gen Med 2021; 14: 3405-3413
- Shah JY, Phadtare A, Rajgor D. et al. What leads Indians to participate in clinical trials? A meta-analysis of qualitative studies. PLoS One 2010; 5 (05) e10730