The current study was structured to collect data regarding attitudes towards and understanding of the written consent form from a group of oncology patients. The results are expected that it plays an effective role in chemotherapy patients’ decision making and prepares them for the treatment process with more accurate and notable information.
Sociodemographic Factors
Firstly, sociodemographic characteristics were collected via the sociodemographic data form. According to the findings in Table 1, most of the patients (53.58%) were 60 years or older with an average of 61.79.
Table 1. Sociodemographic Factors of the Participant
Sociodemographic Factor
|
Frequency (N)
|
Percentage (%)
|
Gender
Male
Female
|
14
14
|
50.00
50.00
|
Ages
Average
< 60
60-69
> 70
|
61.79
13
11
4
|
46.42
39.29
14.29
|
Education Levels
Elementary
Middle School
High School
university
|
5
12
7
4
|
17.86
42.86
25.00
14.28
|
Occupation
Retired
Housewife
Businessman
Other
|
11
8
4
5
|
39.29
28.57
14.29
17.85
|
Types of Cancer
Breast
Colorectal
Lung
Other
|
9
7
5
7
|
32.14
25.00
17.86
25.00
|
Table 1 also shows that the participants were mainly (60.72%) elementary and middle school graduates. The number of male participants was equal to the number of females. Also, most of them (67.76%) were either retired or housewives. Some of them were employed as a teacher, attorney, or police officer. The most common kinds of cancer were found in breast cancer (32.14%) or colorectal cancer (25.00%). Also, nine females were suffering from breast cancer and five males from lung cancer. Other types of cancers were reported as stomach, prostate, and liver cancer. Only three participants were recently diagnosed with cancer and just started chemotherapy treatment.
Knowledge and Perceptions of The Written Informed Consent Form
The first question in the interview protocols was related to how well they knew about the informed consent form. Three indicated that they knew and heard it in the past. Some of them (N= 10) stated that it was handed during the doctor meeting, but others (N= 10) stated no form of any kind before the treatment. Only six patients remembered that they were given a “form or paper” during the meeting. For example, a 37 years old housewife diagnosed with breast cancer said, "I had signed a paper before my surgery. The doctor gave me information before chemotherapy”. In conclusion, the majority of the patients indicated that they did not hear any type of informed consent form. Many patients perceived the informed consent form as just the physicians’ regular reports about the patients’ health conditions during personal interviews. They also did not think the form that includes any specific information for themselves and their medical conditions.
Most of the patients (N=15) said that they were verbally informed about the content of the written consent form. Half of them (50%) stated that they were given sufficient information about the statements in the written consent form. However, some (N=8) believed that inadequate information was provided. One implied that “it wasn’t enough, I was scared because I didn’t have any information about the disease. They should have given some specifics about the drugs and treatment. I think it is somewhat commercial” (42 y.o, housewife, breast cancer). Some believed that the language of the form should be written more clearly for the patients.
Most of the patients believed that the informed consent form was not necessary, but a simple procedure and it should be completed because it gives them more information about the process and better prepares for the treatment. 23 (82%) were satisfied with the delivered information.
Regarding the issues of chemotherapy, the patients were experiencing certain side effects. They also suffer from nausea, loss of appetite, and skin rash. On the other hand, the participants with no side effect credited it to their healthy and strong body structures. An 80 years old housewife suffering from breast cancer explained that “I had dizziness, weakness, loss of appetite, inability to walk, and hair loss. I was feeling better when I stopped the treatment”.
The patients were also asked about the issues related to chemotherapy. 21 participants said that they were previously informed about the side effects. Two didn't have any experience of side effect so didn't know anything about it. They mostly heard about the side effects on the Internet or doctor meetings. Some of them were taking various precautions for protection from the side effects.
Some patients made suggestions to improve the informed consent form such as patients' expectations, more comprehensive explanations of the after-treatment procedure. They also emphasized that it should give more in-depth information regarding employment and social life issues during chemotherapy in addition to providing rich and diverse text content. For example, a 58 years old male patient diagnosed with abdominal mass stated that “I read the informed consent form and it had everything the doctor said. Other than that, what else could be in it? However, the expectations for the patient were missing. For instance, it stated that herbaceous plants were forbidden, but I didn’t know if it included dill and parsley. I later found out that it meant nettle. If it included how we would feel after the treatment, it would be better. I wanted to work but they didn’t inform me about it. Chemotherapy informed consent form is very general. They shouldn’t be a single common form”.
Some of the patients indicated particular factors for not willing to read the informed consent form. They listed the reasons for why not reading it as follows:
- It wasn't written with a plain language,
- Less time and too many patients,
- The patients were shocked when discussing it,
- Felling forced to sign it no matter what,
- Being a novice person in the process,
- Full reliance on the doctor.
Among the aforementioned reasons, the most popular explanations (N=12) were that; because they trusted their doctors and absolute belief in their treatments. Also, seven patients stated that they weren’t given any choices, but they signed it anyway.
Considering whom the written informed consent form should be obtained for, the patients provided different explanations such as only for the patients (N=9) or doctors (N=6) and both of them (N=6). The reason for answering ‘only for doctors' lies in putting the responsibility of the treatment on the patient, protecting their rights in case of any bad scenarios, and proving that the patients were informed. On the other hand, some participants expressed that it was written for the patients only because being better informed about the process, learning any side effects, accepting the treatment consciously. Only two of them didn’t know its purpose. They also listed some reasons behind their responses, “Doctors needs to avoid responsibilities; we learn about negative sides of treatment; practitioner learns them with us”.
Those that adversely affect a doctor's verbal explanation about the process included the patients being shocked, having a bad mood or physical state, relatives conducting the meeting, relatives taking care of the patient, and relatives trying to hide the disease from the patient.
Some of the patients were considering the informed consent form as ‘procedure' and ‘just a formality' because they had to accept the situation and felt completely helpless. Having a misconception about the informed consent form intended to protect the doctor, or the idea that the patients need the form when not trusting in the doctor makes it unnecessary for them.