Attitude of patients with liver cancer toward clinical drug trials: Empirical Qualitative Research

doi:10.21203/rs.3.rs-4867249/v1

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Attitude of patients with liver cancer toward clinical drug trials: Empirical Qualitative Research

https://doi.org/10.21203/rs.3.rs-4867249/v1

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Aims

To explore the attitude of patients with liver cancer toward clinical drug trials and promote the development of clinical drug trials in patients with liver cancer.

Design:

Qualitative study

Methods

In this study conducted in a tertiary hospital, we conducted in-depth interviews in 19 patients with liver cancer, including those who were: 1. diagnosed with primary liver cancer according to the “Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)”; 2. without cognitive or language impairment and were able to express their thoughts; and 3. willing to participate in the study and provided written informed consent. We excluded those with serious physical diseases or other malignant tumors and mental disorders. The attitudes of patients with liver cancer toward clinical drug trials were evaluated along with the awareness of clinical drug trials and factors affecting their participation in order to promote the development of clinical drug trials for this population.

Results

We summarized the attitude of patients to clinical drug trials into two themes. The first involved differences in patients' awareness of clinical drug trials, which comprised lack of awareness, doubts and worries, blind trust in authoritative sources, and rational participation. The second highlighted factors influencing participation in clinical drug trials, which included: 1. positive factors such as a doctor’s recommendation, expectations, peer effect, economic burden, desire to contribute to medical research, and family support, and 2. negative factors consisting of the side effects of drugs, drug safety, and problems guaranteeing patients’ rights and interests.

Conclusion

There were differences in the attitudes of liver cancer patients toward clinical drug trials.

Implications for the Profession and Patient Care:

Researchers should improve the awareness of liver cancer patients with regard to clinical drug trials and understand the factors that affect their participation.

Patient or public contribution

: The patients had no contributions in the design or conduct of the study, analysis or interpretation of the data, or in the preparation of the manuscript

Biological sciences/Cancer

Health sciences/Medical research

liver cancer

clinical drug trial

qualitative research

participation

attitude

Liver cancer is a common malignancy. A survey by the International Agency for Research on Cancer revealed there were approximately 906,000 new cases of liver cancer in 2020, accounting for 4.7% of all cancer incidences. Moreover, liver cancer led to about 830,000 deaths in 2020, accounting for 8.3% of all cancer-related deaths and the second highest mortality rate of cancer among men (Siegel et al., 2020). Considering the insidious onset of neck cancer, although early screening is possible with methods including liver ultrasonography, serum alpha-fetoprotein assay, and liver cancer risk assessment (Fan et al., 2020), the proportion of patients who are suitable for radical surgery at the first diagnosis is still below 30% (Bureau of Medical Administration, National Health Commission of the People’s Republic of China, 2022). Systemic antitumor therapy is crucial for treating advanced liver cancer.

A clinical drug trial is the systematic study of a drug in an individual (patient or volunteer) to determine drug safety and efficacy (The State Council of the People’s Republic of China, 2020), and its success relies on the number and characteristics of the recruited participants. However, it is difficult to motivate patients to participate in clinical trials and, with the low rate of active participation (Kong et al., 2016), compliance is often compromised due to passive participation (Liu et al., 2019). Previous research (Lara et al., 2005; Huang, Fan, et al., 2020) has suggested that patients’ participation in clinical trials is directly affected by their awareness of the trials. Huang, Fang, et al. (2020) reported that cancer patients in China have limited awareness of clinical drug trials, with only 54.6% possessing a correct view. Further, research is scarce regarding the specific aspects of patients’ insufficient awareness of clinical drug trials, their individual differences, and factors affecting participation.

3.1 Aims and Objective

This study identified the awareness of clinical drug trials among these patients and explored factors affecting their participation in order to promote the development of clinical drug trials for this population.

4.1 Design

We adopted a phenomenological research method to investigate the attitudes of patients with liver cancer toward clinical drug trials.

4.2 Sampling and Recruitment

Between March and August 2021, patients with primary liver cancer were recruited at the hepatobiliary surgery department of our tertiary grade A hospital, using purposeful sampling.

The sample size was determined based on the principle of data saturation.

4.3 Inclusion and Exclusion Criteria

The study included patients who were: 1. diagnosed with primary liver cancer according to the “Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)” (Bureau of Medical Administration, National Health Commission of the People’s Republic of China. Guidelines for the diagnosis and treatment of primary liver cancer, 2022); 2. without cognitive or language impairment and were able to express their thoughts; and 3. willing to participate in the study and provided written informed consent. We excluded those with: 1. serious physical diseases or other malignant tumors; and 2. mental disorders.

4.4 Interview

A draft interview outline was first formulated after a literature review (Huang, Fan, et al., 2020; Lara et al., 2005; Liu et al., 2019) and group discussions; the outline was used to pre-interview three patients with liver cancer. The draft was then revised based on pre-interview findings and further discussed by the research team before finalization. The main contents of the interview outline included: 1. Do you know what a clinical trial is? How did you find out about clinical trials?; 2. Are you willing to participate in clinical trials? Why?; 3. What are the factors that may affect your consent and willingness to participate in a clinical trial?; 4. Can you talk about your family’s or friends’ attitudes and views on clinical trials? How do these attitudes influence your decision-making?; 5. Are you aware of the rights and obligations of participating in clinical trials?; 6. Are you aware of relevant laws and regulations for clinical trials in China? What contents are you interested in learning?; 7. What concerns do you have about clinical trials?; 8. What do you hope to gain from participating in clinical trials?; 9. After being admitted to a clinical trial, what difference did you feel compared to the previous regular (self-funded) examinations and treatment in the hospital?; and 10. How do you feel the clinical trial can be improved? What are the current shortcomings?

4.5 Data collection

A semi-structured in-depth interview method was utilized. Before the interview, researchers introduced the research to the interviewees. Once consent was obtained, to make it easy for the interviewees, the interview time was set to avoid treatment or meal schedules, while the interview venue was located in a small meeting room in the ward with a quiet environment and privacy. The primary research tools were the researchers who were professionally trained in qualitative research and qualified to conduct interviews. The researcher asked the interviewee questions according to the interview outline. Each interviewee was interviewed once for 20–30 min. With the interviewee’s consent, the interview process was recorded and notes were taken. During the interview, the researcher closely monitored the interviewee’s non-verbal expressions, including facial expressions and body motions. Any ambiguous information during the interview was promptly clarified, and leading questions and hints were avoided.

4.6 Data analysis

This study adopted Colaizzi’s seven-step method for data analysis (Qi & Lv, 2021). To ensure data authenticity and accuracy, recordings were transcribed within 24 h of each interview. By combining onsite interview notes with situational recall, researchers carefully and repeatedly listened to the recordings and analyzed the data word by word. Once important statements were extracted, recurring and meaningful opinions were coded and divided into different categories to determine similarity. After a theme was sublimated, it was verified with the interviewee. The recordings were transcribed and organized by two researchers who independently extracted codes, categorized participants, and summarized themes. Upon disagreement, consensus was reached via group discussion to ensure result accuracy.

4.7 Ethical Considerations

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the ethics committee of the hospital.

5.1 Participants

Nineteen patients with primary liver cancer (A1–A19) were interviewed. Their general information is presented in Table 1. Most were male (84.2%), had a monthly income of < RMB 1500 (47.4%), had an educational level of junior high school (52.6%), and had rural cooperative (63.2%) and rural (57.9%) type medical insurance. The mean age of the participants was 56.47 ± 10.20 years. Most (52.6%) did not have previous experience in clinical trials.

Table 1

General participant information.
Number	Sex	Age	Monthly income	Occupation	Health insurance type	Educational level	Place of residence	Previous experience in clinical trials
A1	Male	60	3000–5000	Culture, education, health, and sports personnel	Employee medical insurance	Junior high school	Urban	Yes
A2	Male	60	< 1500	Farmer	Rural cooperative medical insurance	Primary school	Rural	Yes
A3	Male	57	1500–3000	Farmer	Rural cooperative medical insurance	Primary school	Rural	No
A4	Male	56	< 1500	Farmer	Rural cooperative medical insurance	Senior high school	Rural	Yes
A5	Male	52	Fluctuates	Farmer	Rural cooperative medical insurance	Junior high school	Rural	No
A6	Male	60	< 1500	Farmer	Rural cooperative medical insurance	Primary school	Rural	Yes
A7	Male	72	1500–3000	Farmer	Rural cooperative medical insurance	Primary school	Rural	Yes
A8	Female	39	< 1500	Farmer	Rural cooperative medical insurance	Junior high school	Rural	No
A9	Male	57	3000–5000	Worker	Employee medical insurance	Senior high school	Urban	No
A10	Male	59	3000–5000	Worker	Employee medical insurance	Senior high school	Urban	Yes
A11	Male	64	3000–5000	Retired	Employee medical insurance	Junior high school	Urban	No
A12	Female	78	3000–5000	Retired	Employee medical insurance	Junior high school	Urban	Yes
A13	Male	65	< 1500	Farmer	Rural cooperative medical insurance	Junior high school	Rural	Yes
A14	Male	42	Unknown	Enterprise employee	Employee medical insurance	Unknown	Urban	No
A15	Male	50	< 1500	Farmer	Rural cooperative medical insurance	Junior high school	Rural	Yes
A16	Female	48	< 1500	Unemployed	Rural cooperative medical insurance	Junior high school	Urban	No
A17	Male	40	< 1500	Farmer	Rural cooperative medical insurance	Junior high school	Rural	No
A18	Male	63	< 1500	Farmer	Rural cooperative medical insurance	Primary school	Rural	No
A19	Male	51	3000–5000	Worker	Employee medical insurance	Junior high school	Urban	No

5.2 Themes

Two major themes were yielded: differences in patients’ awareness of clinical drug trials and factors affecting participation in clinical drug trials. Illustrative quotes for each theme are presented in the text and in Table 2.

Table 2

Identified themes and example quotations.
Theme	Example quotations
Theme 1: Differences in patients’ awareness of clinical drug trials
Insufficient awareness	A1: “I have neither considered nor attempted to understand clinical trials. If there is any information (laws and regulations) available on them, please send it to me, as I would like to learn about it.” A2: “I do not know (what rights I have) or understand (relevant laws and regulations).” A3: “We definitely are unaware of it.” A6: “I have forgotten what they said, as it was last year.” A7: “I do not know much about the rights and laws or regulations.”
Doubts and concerns	A2: “I am definitely hesitant, especially regarding whether my physical condition is appropriate for the trial.” A3: “I do not trust the drug used in the clinical trial.” A4: “At the beginning, I was reluctant and scared of the clinical trial. My first reaction was that the clinical trial was experimenting on us to acquire data.” A10: “I was concerned about drug toxicity and risks of dermatitis, rash, hypertension, etc. before the clinical trial.” A11: “I have a bottom line for drug efficacy—I will not be hesitant about participating in a clinical drug trial if the success rate is approximately 80%. When you fight an unknown enemy, you will naturally worry about attacking underprepared.” A12: “I did not believe the drug efficacy. I was taking one pill daily for a total of 15 pills, but I stopped the drug myself.” A15: “I am definitely concerned.” A16: “Will the clinical trial be strictly conducted according to the doctor’s prescription? Will additional drugs be used?” A17: “The drug is unsafe as it is still in the research stage.”
Blind trust	A1: “I believe in science and medicine. Every drug must undergo clinical trials before its commercialization.” A7: “I trust my doctor and I am supported by my family who believe hospitals and doctors should be responsible for making the call.”
Rational participation	A6: “I was referred by Director XX. Later, I consulted with my sister-in-law, who studied medicine, and she said it was okay to participate.” A8: “I browsed the internet for information and learned that several patients who lived here participated and had good outcomes at the time.”
Theme 2: Factors affecting participation in clinical drug trials
Positive factors
Doctor’s recommendation	A1: “You must trust your doctor rather than believing in yourself for everything. Doctors cannot recommend bad treatment to patients.” A2: “I will definitely cooperate with doctors. Since this is an authoritative hospital, I must listen to the doctors.” A4: “I was referred by my outpatient physician. Not only is this a big hospital, but the treatment is available in several large hospitals.” A6: “Director XX recommended the clinical drug trial to me. He mentioned that the drug was a 1:1 duplicate of an imported drug, and the domestic version had the same efficacy.”
Expectations and hopes	A1: “It is worth trying and can probably yield good results.” A2: “If the doctor told me to come back in 20 days for treatment, I would definitely follow his/her instruction without delay. We want good treatment outcomes.” A4: “I hope to find a good hospital and effective drugs.” A8: “Since this disease cannot be cured, I am willing to have a few more years of treatment to let you try out the medicine. Given the trial drug is free, I’ll try it.” A9: “Since this is a new drug, I am willing to try it. There is no harm in trying this new drug, especially when existing treatment cannot cure my disease.” A11: “The stronger the effect, the better the drug. It is best that the trial drug can cure the disease. Although I know it might fail, I would like to try my luck.”
Peer effect	A4: “A patient in our village was diagnosed with advanced-stage cancer. I heard people around him say that it was okay to participate in this (clinical trial).” A5: “A fellow villager also participated in the trial and was prescribed with targeted drugs.” A8: “Several patients in this ward participated in the trial and had good outcomes.”
Economic burden	A1: “If not for the economic factor, I probably would not choose clinical trials.” A2: “My family is from the rural area. We are poor and cannot afford treatment.” A4: “I participated in the clinical trial mainly because of financial reasons as the clinical trial was free and could reimburse some transportation costs.” A5: “I will consider participating in clinical trials only if I am poor. If I am wealthy, I will not participate in clinical trials as they are risky.” A6: “The financial condition of my family is not great; therefore, I’ve chosen to participate in the clinical trial to save some money, particularly when subsequent treatment is costly.” A7: “I will not participate in the clinical trial if it is not free. I will not be able to continue treatment without a free trial.” A13: “I am from the rural area, and my family does not have the financial capacity to support my treatment.” A16: “I had targeted drugs, which cost more than RMB 20,000. I then ran out of money and could not continue drug administration. I will participate in a clinical trial as long as it is free.” A17: “I will participate in a clinical trial as long as it is free.”
Contribution to the cause of medicine	A11: “I am retired now and cannot make any further contributions. Since I am diagnosed with liver cancer, I could die soon. Therefore, I would like to make some contributions to medical research before dying.” A12: “After they discussed it with me, I thought in my heart that since I was old, I might contribute to medical research anyways to benefit my country.”
Family support	A2: “My family supports my participation. They want me to become better.” A6: “My family is supportive.” A11: “My daughter thinks it is okay to participate in the clinical trial. She has seen some people who are engaged in clinical trials and can visually tell that they look okay.” A12: “My children persuaded me to participate in the clinical trial. They said that I should believe in science.” A18: “All decisions were made by my family. I just followed whatever decision they made.” A5: “My family asked me to take this drug, but I was worried I would not be able to afford it over an extended period.”
Negative factors
Drug side effects	A2: “Clinical trial drugs can cause side effects and adverse reactions. I felt very uncomfortable during food intake in the clinical trial.” A4: “The drug reaction was strong. While I felt okay indoors, I usually felt uncomfortable outdoors. Moreover, I felt constant pain in this area (abdomen), and my neck and hands would become itchy (rashes) when exposed to the sun.” A6: “I took the drug for about 20 days, after which I experienced liver and kidney dysfunction and blood clots, forcing me to withdraw from the trial.” A12: “After taking the targeted drug, I had no strength at all, my feet became inflamed, and I could not sit due to skin ulceration.” A15: “I am fully aware that the drugs I take now are toxic, and I am expecting adverse reactions, such as increased blood pressure and hypothyroidism.”
Drug safety	A3: “We do not trust the drug.” A14: “My concern is that there is insufficient research on the drug, and it may introduce side effects.” A16: “I am concerned that the drugs are different. Clinical trial drugs are free and therefore may not be good.” A17: “I am mainly worried about safety.”
Incapability to ensure individual rights	A2: “I asked the clinical coordinator once about the reimbursement and he escalated it for me, but the payment has not arrived. The coordinator promised that the cost of each examination would be reimbursed, but this has not been done.” A6: “At the time, a subsidy was promised, and we expected to be credited in about 6 months. However, it has been 8–9 months into the trial and the payment has not arrived, making me wonder what is going on.” A7: “I am dissatisfied with the reimbursement, which has not been credited in a year. I hope it will be paid soon.” A12: “I asked the clinical coordinator when the promised reimbursements would arrive, and she told me to wait for another 2 years. I am surprised such a small thing cannot be fulfilled earlier. I wonder if I can wait for 2 years, and if I will lose the benefits upon death.”

5.2.1 Theme 1: Differences in patients’ awareness of clinical drug trials

5.2.1.1 Insufficient awareness

Only nine participants had previously participated in clinical trials. Although those without previous experience in clinical drug trials had heard of such trials, they were unaware of relevant laws and regulations or their rights and obligations; even participants who had participated in clinical trials demonstrated insufficient understanding of these aspects. Since these participants urgently required relevant information on clinical drug trials, researchers explained it to them individually to allow them to fully understand clinical drug trials and, on this basis, actively engage in them.

5.2.1.2 Doubts and concerns

Nine participants expressed significant doubts and concerns about the safety, efficacy, and side effects of clinical trials. Further, two participants mentioned that the screening period was extensive, and that they were concerned that the waiting period when no treatment was provided could aggravate disease progression. A1: “The waiting period is too long, during which you receive no treatment for 10–20 days. I felt very anxious during the waiting period, and was wondering if some other medicine should be prescribed to control the disease to some degree.” A2: “We have waited for at least 21 days without taking drugs. I am already sick, and yet the trial does not let me take any medicine for many days.”

5.2.1.3 Blind trust

Once patients learn they have liver cancer and the disease has progressed to the middle or advanced stage, they rely more on professional doctors. Most patients place their hopes on authoritative hospitals or professors for new treatment methods. The inherent belief that clinical drug trials represent the latest and best drug treatment makes patients have high expectations.

5.2.1.4 Rational participation

Two participants stated that they proactively learned the basic information of clinical drug trials by consulting professional doctors, browsing the internet for relevant information, and asking other patients with previous experience. Since they had a good understanding of the pros and cons of clinical drug trials, they were able to approach the clinical trial rationally and actively participate in the treatment.

5.2.2 Theme 2: Factors affecting participation in clinical drug trials

5.2.2.1 Positive factors

5.2.2.1.1 Doctor’s recommendation

Most participants in this study mentioned that they participated in clinical drug trials owing to the recommendation of their attending physicians.

5.2.2.1.2 Expectations and hopes

In this study, most patients’ disease was in the middle or advanced stage, and surgery was infeasible. Since existing treatment methods could introduce serious side effects without producing satisfactory outcomes, participants had high expectations of clinical trial drugs.

5.2.2.1.3 Peer effect

For some patients with liver cancer, in addition to the influence of medical personnel, whether patients with the same disease had participated in clinical trials seemed to affect their willingness to participate in trials. Three participants stated that they participated in the trial because patients in the same village/ward participated and felt that the drug had good efficacy.

5.2.2.1.4 Economic burden

The high cost of liver cancer treatment has brought a huge economic burden to patients’ families. In this study, most participants were male. Under traditional Chinese Confucianism, it is generally believed that men are the economic backbone of the family. If they become ill, male patients receive no further economic income and still have to take the responsibility of caring for parents, raising children (minors), and paying medical, transportation, and other expenses. Therefore, the disease has significantly increased the economic burden on non-wealthy families. Thus, the fact that clinical drug trials are free and can reimburse some transportation costs can alleviate the economic burden on families. In this study, nine participants participated in clinical drug trials because of the family’s financial burden.

5.2.2.1.5 Contribution to the cause of medicine

Two participants mentioned that they could contribute to medical research by participating in clinical drug trials; this provided them with a sense of value even though they were ill.

5.2.2.1.6 Family support

Five participants stated that they were willing to participate in clinical drug trials because of the support or advice of their family. One participant refused to participate in a clinical trial despite family support. Contrastingly, one participant insisted on participating in a clinical drug trial (due to economic burden) despite the objection of his family. The other five participants (A9, A14, A16, A17, and A19) who had not participated in clinical drug trials claimed that their participation would depend on their thoughts, and they believed that family members’ opinions were only for reference.

5.2.2.2 Negative factors

5.2.2.2.1 Drug side effects

Five participants who had previous experience in clinical drug trials mentioned that the drug side effects were significant, and that they were concerned with the efficacy of the drug and whether their physical conditions could sustain the drug. Two participants withdrew from trials due to a deteriorating physical condition.

5.2.2.2.2 Drug safety

Four participants who had not participated in clinical drug trials expressed that their major concern regarding clinical drug trials was drug safety given that these drugs may have many unknown side effects. They mentioned being afraid of these drugs further impacting their health.

5.2.2.2.3 Incapability to ensure individual rights

Six participants in this study who had participated in clinical drug trials mentioned that the reimbursement period was too long, which led to doubts about reimbursements and lack of confidence in clinical coordinators. Some of them mentioned doubting whether the costs would ever be reimbursed.

6.1 Differences in the awareness of clinical drug trials among patients with liver cancer

This study showed differences in awareness regarding clinical drug trials among liver cancer patients. Most patients had insufficient awareness concerning clinical drug trials and required relevant information, which is consistent with the findings of Huang, Fang, et al. (2020) and Qi & Lv. (2021). Numerous clinical trials on antitumor drugs have recently been conducted in China, greatly increasing the demand for participants (Center for Drug Evaluation, State Drug Administration, 2022; Li et al., 2019). However, the number of available participants is limited compared to the amount of newly diagnosed liver cancer patients. A study (Chen et al., 2014) suggested that participant recruitment affected clinical trials. Patients’ participation in clinical drug trials highly depends on their awareness of the trial (Lara et al., 2005; Huang, Fan, et al., 2020). Chu et al. (2015) revealed that a higher patient awareness of clinical drug trials increased active participation. Therefore, it is crucial to raise public awareness of clinical drug trials.

Internationally, countries have introduced measures such as setting up popular science websites and holding scientific and educational activities for clinical drug trials (Michaels et al., 2012; Solomon et al., 2009), which have successfully increased public awareness of clinical drug trials from 68–74% (Leiter et al., 2015). In contrast, the amount of domestic scientific education on clinical drug trials is extremely limited. Huang, Fang, et al. (2020) surveyed cancer patients’ awareness of clinical drug trials and reported that only 54.6% of the patients had a correct overview of clinical drug trials, whereas the awareness of relevant laws and regulations, medical expenses, and economic compensation was as low as 50%. Alternatively, Cao et al. (2017) conducted a survey on the awareness of clinical drug trials among outpatients at the departments of internal medicine, surgery, and obstetrics and gynecology in a hospital, and found that not only was the rate only 31.02%, more than half of the patients lacked a correct understanding of clinical drug trials. Factors that have contributed to the differences in the awareness of clinical drug trials of patients in China are outlined below.

The first involves differences in cognitive methods. Most studies measure patient awareness of clinical drug trials by assessing whether they have “heard” of the trials. However, a study indicated that whilst the awareness rate of clinical drug trails was high, only few participants held a correct understanding of the trial (Lim et al., 2017). This finding indicates that the nurses need to promote the clinical trial among liver cancer patients.

The second factor concerns insufficient publicity and education on clinical drug trials. Currently, there are inadequate official recruitment platforms and promotions on clinical drug trials in China. Therefore, the public has insufficient access to relevant knowledge on clinical drug trials and predominantly relies on recommendations by medical personnel, implying that the awareness of clinical drug trials among patients with liver cancer should be promoted via other methods. First, as nurses, who have the closest contact with the patients, we can improve the doctor-patient relationship and encourage patients to join the promotion of clinical drug trials. Relevant information should be delivered via simple and straightforward written and oral educational material to increase public awareness. Second, the internet should be utilized to establish additional popular science websites that can strengthen the delivery and education of basic knowledge on clinical drug trials, thereby reducing patients’ concerns.

The third factor is insufficient informed consent. Although patients with previous experience in clinical drug trials demonstrate a better awareness than those without such an experience, their awareness regarding aspects, including financial compensation, legal protection, and overview of clinical drug trials, is not necessarily superior (Huang, Fang, et al., 2020). This possibly highlights the reasons underlying insufficient informed consent and the weaknesses in the process of clinical drug trials. The finding implies that the primary investigators need to design a more rigorous and comprehensible informed consent form, and ensure the effectiveness and adequacy of informed consent. Nurses can facilitate the process of informed consent.

6.2 Factors affecting the participation of patients with liver cancer in clinical drug trials

The factors affecting the participation of patients with liver cancer in clinical drug trials in this study were consistent with those reported by Huang, Fan, et al. (2020) and Lang et al. (2019) The current study found that factors that would promote the participation of patients with liver cancer in clinical drug trials included a doctor’s recommendation, expectations, peer effect, economic burden, contribution to the cause of medicine, and family support, with a doctor’s recommendation being the most important, which is consistent with the results of relevant research. Jacobs et al. (2014) suggested that doctors were crucial in the process of participant recruitment during clinical trials. Similarly, Lang et al. (2019) indicated that a doctor’s recommendation was the key reason for cancer patients consenting to clinical drug trials. Therefore, to improve patients’ participation in clinical trials, it is crucial to fully utilize doctors.

Another factor that encouraged patients in this study to participate in clinical trials was the economic factor. Since most patients enroll in clinical trials to gain access to free treatment, transportation subsidies, and other benefits, it is established that medical benefits are a critical motivation for patient participation. Family support also plays an important role in encouraging patients to participate in clinical drug trials. Under the subtle influence of traditional Chinese Confucianism, individuals are closely bonded with their family. Therefore, whether a patient should participate in a trial is not a personal decision but rather a family decision. However, some researchers do not fully understand this complexity regarding patient participation in clinical drug trials. Moreover, most researchers notify patients without assessing if the information is relevant to the patient, whereas family members usually understand the real needs of patients when making decisions. Therefore, researchers should pay attention to the important role of family support in patients’ participation in clinical drug trials.

Other factors that motivated patients in this study to participate in clinical drug trials included expectations, peer effect, and contribution to the cause of medicine. Our findings showed that: 1. some patients placed their hopes on new drugs/treatment methods, expecting them to provide better medical experience and treatment outcomes; 2. a small number of patients gained confidence regarding treatments from the successful experience of others; and 3. two patients withdrew because of side effects. The patients hoped that the medical research field in China would develop rapidly, and new drugs for the treatment of liver cancer would be invented to alleviate patients’ pain. At the same time, they understood that the clinical application of new drugs relied on clinical trials, and therefore decided to contribute to medical research by participating in clinical trials.

Factors that discouraged patients from participating in clinical trials mainly included drug side effects, drug safety, and the incapability to ensure individual rights. Drug efficacy, side effects, and safety were the participants’ greatest concerns. Therefore, before trials, researchers should fully inform the patients of the risks, grouping methods, and possible adverse reactions, as well as establish emergency plans. During a trial, adverse reactions should be closely monitored and treated, and a standardized management process should be implemented. Financial compensation is also pivotal in clinical drug trials. In this study, six participants mentioned that after participating in clinical trials, the promised reimbursements were not paid promptly, thereby causing their mistrust of the clinical coordinators. Presently, there are multiple pharmaceutical companies in China, each with different reimbursement systems. Reasonable economic compensation for clinical trial participants is both an ethical and legal requirement. Therefore, corresponding regulations should be improved, and the reimbursement process and period should be optimized to protect the interests of trial participants. Nurses can provide emotional support to relieve the participants’ distress related to the financial issues.

6.3 Strengths and Limitations of the Work

This study used qualitative interviews to explore the attitude of patients with liver cancers toward clinical drug trials. However, this study had certain limitations. First, although we tried to include participants with the maximum amount of variation in characteristics, the youngest participant was aged 39 years. In future studies, it may be beneficial to include young patients to capture their views on clinical trials. Second, the results may be limited in terms of generalizability as all the participants were recruited from a single hospital. The patients’ perceptions of participating in clinical trials may vary with their experience at different hospitals.

This study investigated the attitudes of patients with liver cancer toward clinical drug trials by performing qualitative interviews with 19 patients with primary liver cancer. Two themes were highlighted from the interviews. Our results can help medical staff gain an in-depth understanding of the awareness of clinical drug trials among patients with liver cancer and their individual differences as well as factors affecting their participation. Nurses can improve the awareness of clinical drug trials among patients with liver cancer and, based on this, encourage participation by specifically targeting the provision of relevant information on clinical drug trials.

Author Contribution

WL, JL, SG; Data curation: WL, JL; Formal Analysis: WL, JL; Funding acquisition: WL, JHL; Investigation: JL; Methodology: WL; Project administration: WL; Resources: WL; Supervision: SG; Writing – original draft: WLWriting – review & editing: SG, JHL

Data Availability

Data availability statementThe data that support the findings of this study are available from the corresponding author, SG, upon reasonable request.

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No competing interests reported.

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You are reading this latest preprint version

Attitude of patients with liver cancer toward clinical drug trials: Empirical Qualitative Research

Status:

Version 1

Abstract

Aims

Design:

Methods

Results

Conclusion

Implications for the Profession and Patient Care:

Patient or public contribution

1 Introduction

2 Background

3 The Study

3.1 Aims and Objective

4 Methods

4.1 Design

4.2 Sampling and Recruitment

4.3 Inclusion and Exclusion Criteria

4.4 Interview

4.5 Data collection

4.6 Data analysis

4.7 Ethical Considerations

5 Findings

5.1 Participants

5.2 Themes

5.2.1 Theme 1: Differences in patients’ awareness of clinical drug trials

5.2.1.1 Insufficient awareness

5.2.1.2 Doubts and concerns

5.2.1.3 Blind trust

5.2.1.4 Rational participation

5.2.2 Theme 2: Factors affecting participation in clinical drug trials

5.2.2.1 Positive factors

5.2.2.1.1 Doctor’s recommendation

5.2.2.1.2 Expectations and hopes

5.2.2.1.3 Peer effect

5.2.2.1.4 Economic burden

5.2.2.1.5 Contribution to the cause of medicine

5.2.2.1.6 Family support

5.2.2.2 Negative factors

5.2.2.2.1 Drug side effects

5.2.2.2.2 Drug safety

5.2.2.2.3 Incapability to ensure individual rights

6 Discussion

6.1 Differences in the awareness of clinical drug trials among patients with liver cancer

6.2 Factors affecting the participation of patients with liver cancer in clinical drug trials

6.3 Strengths and Limitations of the Work

7 Conclusion

Declarations

Author Contribution

Data Availability

References

Additional Declarations

Status:

Version 1