14. Informed Consent Pathway Example
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Informed Consent Pathway
We will now demonstrate how the communication pathway can guide the process of informing people about trials and help them to reach a decision. The study we have selected is an Australian randomised control trial of surgery alone versus chemoradiation followed by surgery for people diagnosed with oesophageal cancer. This study was conducted by the Australasian Gastro Intestinal Trials Group, AGIT, and the Trans-Tasman Radiation Oncology Group, TTROG. The results of the study were published in 2005 and a copy of the paper is available as part of this learning module if you would like to read more about this treatment.
Oesophageal Trial: Aims and Outcomes
The aim of this randomised control trial, which we will call the Oesophageal trial, was to investigate the effect of giving people diagnosed with oesophageal cancer chemotherapy combined with radiotherapy before surgery on stopping the cancer growing or getting worse. Oesophageal cancer, in case you aren’t sure, is a cancer of the gullet, that is, the tube that transports food and liquid from your mouth to your stomach. The main outcome of the study was progression free survival. This means the researchers wanted to know if adding chemotherapy combined with radiotherapy, before the surgery, resulted in people living longer without the cancer getting worse. This would include the cancer growing during the preoperative chemoradiation as well as the cancer coming back after surgery, or if the surgeon was able to remove all of the tumour during surgery. The researchers also wanted to know if adding extra treatment before surgery meant people lived longer overall, if their cancer or tumour got smaller during the chemoradiation, whether they were sicker than if they’d just had surgery alone, what happened after the treatment when the cancer came back, and how the treatments changed patients’ quality of life.
Trial Design
This study was a randomised control trial with two parallel arms. This means the study participants were randomised between two possible treatments. The first was surgery alone, the standard of care at the time, which anyone with resectable oesophageal cancer would be offered. The second was the experimental treatment and lasted three weeks and involved chemotherapy at the hospital on one day and then a total of course days of chemotherapy given by a long infusion with a little pump that patients carried with them over the whole four days. They also had radiotherapy every day for 15 days before their surgery. After the treatments were complete, participants saw their treatment doctor every three months to see how they were, and if their cancer had come back or was getting worse. Their doctor also checked to see if the treatments had caused any undesirable side effects, as well as getting people to fill out a questionnaire about their quality of life. Patients and doctors contributed data to the study until the participants died.
Framework of Mutual Understanding
It is important to establish a framework of collaboration and mutual understanding of the patient’s situation. This helps to work out how the patient and clinician can work together to decide about the treatment approach that best suits this person.
Bearings
During the bearing stage there are a number of activities that can help to establish a collaborative framework for the rest of the consultation. It helps if the doctor has done some preparation, that they know the patient’s diagnosis and results any of other tests performed already. They have in their mind what the treatment options would be, including a clinical trial, if relevant. Agenda setting involves encouraging the person with cancer to state what they want from the consultation, the doctor or the recruiter stating their agenda, as well as explicitly encouraging the patient to ask questions. It is important to hear the patient’s story from them rather than make assumptions about what they do or don’t know. This helps to establish a shared agreement about the patient’s situation. Underpinning this process is compassion and empathy from the doctor. We know from other research that very simple statements such as “this is a very difficult time for you, but we’ll work together to get through it” effectively convey empathy and compassion. They also help patients feel more supported by their doctors.
Standard Treatment
During pathway one, the doctor provides information about standard treatments.
Pathway 1
In the oesophageal trial, the standard management option would have been to have surgery to remove or resect the tumour. After surgery, depending on how it went, the kind of tumour, where it was and how completely it was resected, additional follow-up treatment such as chemotherapy and/or radiotherapy might have been considered. The surgery for oesophageal cancer is substantial and can take some time to recover from. Talking to people about this, what to expect and how long the recovery would take is important to help them understand what is involved. It would also help to draw out or elicit any concerns people had about this treatment, ensuring that the individual explicitly gave consent and agreed to have surgery was important.
Pathway 2
Only after consent to have active treatment was obtained would the doctor introduce the consent to the clinical trial. Here they talk about clinical trials in general, why they are done and then about the trial relevant to this situation.
Oesophageal Cancer Trial
As part of discussing the oesophageal trial, a doctor would outline the aim or the goal of the trial by saying something like, as we have already talked about, most people in your situation are treated with surgery to remove the tumour. However, we are running a study to see if giving people some chemotherapy combined with radiotherapy before surgery helps to remove the cancer and therefore the chance that people will live longer without the cancer returning or getting worse. Describing medical studies might include some of the following statements. We do medical studies or clinical trials to see if one treatment works better than another. We do this by comparing the results of treatment in two groups of people who are the same. The doctor would explain about randomisation in general, as well as how it works in this trial, why we compare the results of new treatment approaches to the standard care, the risks and benefits to each treatment, as well as emphasising that the choice to take part in a trial is the patients, and that their ongoing care will not be influenced by their decision to take part in this trial or not.
Randomisation
Randomisation is a complex concept that many people have difficulty understanding. But for anyone considering consent to participate in a randomised trial, it is important that they understand it. There are three concepts an individual needs to understand; why randomisation is used, how it works in this trial and the implication that if the individual decides to take part in the trial, they will need to be happy with any of the possible treatments as the treatment they will receive will not be decided by them or their treating doctors.
Randomisation
Here are some examples of what doctors might say about randomisation. You might like to take some time to read through these statements now.
Summarising
Once these things have been discussed, summarising the discussion and the advantages and disadvantages of the experimental treatment can assist in reaching a decision. Here some of the advantages might include the extra treatment might improve chances of living longer without the cancer coming back and getting worse. If the cancer does get worse during the preoperative chemoradiation, it might mean you avoid an operation that won’t help and that might take you a long time to recover from. Participating in the trial contributes to medical knowledge and may be able to improve treatment for people in the future. Some of the disadvantages are listed here, and they might include extra side effects of the treatments, not getting the surgery, having to wait for surgery and completing questionnaires during the follow-up visits.
Patient Voice
Listening to the patient voice involves trying to clarify and calibrate the individual’s values in the context of available treatment. This can be achieved by inviting the patient to discuss their concerns, what is important to them, any lifestyle factors that are important to them, and to encourage them to ask questions.
Recommendation
To help patients reach a decision, it is helpful for the doctor to make a clear statement that either the standard treatment or the trial would be acceptable treatment options for a person in their situation. It is probably sensible to reinforce the understanding that whatever decision, their care will not be compromised.
Patient Decision
Listening then to the patient’s response to information regarding the trial will help to achieve a decision.
The Next Step
If the patient then decides to participate in the trial, a practical application of the decision is needed. This means talking about what happens next.
Conclusion
Gaining consent is a complex process requiring a great deal from both doctor and patient.
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