Informed consent is a legal and ethical concept. It refers to a medical permission or decision given by a patient after being informed about the diagnosis, treatment, tests, or procedures related to a disease [1
]. Also, patient autonomy rights empowers patients to choose proper treatment and make medical decisions based on their medical diagnosis [2
]. However, knowing a life-threatening diagnosis (e.g., cancer diagnosis) often imposes a crisis on the patients. They have to confront the illness and its treatment. They also have to deal with issues related to the meaning of life, death, an uncertain future, and negative emotions (e.g., anxiety, distress, depression) related to the cancer diagnosis [4
], which may decrease their quality of life and shorten the prognosis.
In China, the most common approach to disclose a cancer diagnosis is the “family consent for disclosure” method [4
]. According to the law of the People’s Republic of China on Medical Practitioners, health care providers have the obligation to disclose the truth to the patients and their family members; they also have the responsibility to take necessary actions to avoid adverse consequences related to the diagnosis disclosure [5
]. Therefore, in clinical practice in China, the “family consent for disclosure” approach was frequently used by the health care providers to disclose a life-threatening diagnosis (e.g., cancer diagnosis) [6
]. In these circumstances, health care providers choose to disclose patients’ cancer diagnosis to their caregivers primarily, and then caregivers make the decision about further cancer diagnosis disclosure [6
]. This diagnosis disclosure strategy avoids a direct interaction between health care providers and patients. It reduces the possibility of bringing a high level of anxiety and distress to patients. However, from the legal and ethical aspects, it is inconsistent with patients’ informed consent and personal autonomy rights [1
]. Furthermore, in this situation, caregivers were placed in a difficult dilemma. They had to decide whether to disclose the cancer diagnosis to the patient, how, when, and what to do to reduce unnecessary anxiety and distress brought to the patient. It may increase the anxiety and distress level of caregivers, thus affecting the quality of supportive care they provided to the patients.
According to Leckie [8
], appropriate information could help patients know their health condition, improve their participation in the treatment, decrease their anxiety and distress levels, help them to feel safe, satisfied, and valued, and meet the psychological needs of patients with self-esteem and respect [8
]. As a result, patients’ psychological function and social function improved significantly. Also, results from the study conducted by Montgomery et al. [9
] showed that due to the undisclosed diagnosis, patients may not be able to fully understand and adhere to the treatment. With the progress of the treatment and the occurrence of adverse reactions, patients may suspect the kindly-told diagnosis or undisclosed diagnosis. When there was no way to confirm, patients’ anxiety or distress levels were even higher than that of patients who had already known their disease diagnosis [9
]. Therefore, cancer diagnosis disclosure should be done with caution and well preparedness.
The SPIKES protocol is a ‘bad news’ delivering guideline which is popularly used in the United States [10
]. It has reached guideline status in America and in a number of other countries [11
]. It is used as a guide for sensitive practice and for communication skills training [12
], with a special application for cancer patients [13
]. However, there is a lack of reports about its application in Chinese health care settings.
With the purpose of exploring the influence of cancer diagnosis disclosure and psychological care intervention on the quality of life of the informed person (patients or caregivers), this study applied the SPIKES protocol to disclose cancer diagnosis in elderly cancer patients and implemented psychological care for the informed person after cancer diagnosis disclosure. The informed person’s quality of life was measured sequentially to test the effect of cancer diagnosis disclosure and psychological care intervention. The hypothesis related to the aims of the study were: 1. No significant decrease was found in the informed person’s quality of life after the cancer diagnosis was disclosed; 2. The informed person’s quality of life increased significantly after the psychological care intervention was implemented.
To our knowledge, to date, this study is the first application study using SPIKES protocol to disclose cancer diagnosis among Chinese patients. Cancer diagnosis disclosure is a difficult situation to be handled, which may arouse long-term distress and anxiety [24
]. Previous studies [27
] showed knowing a cancer diagnosis had a significant influence on the informed person’s psychological and social functions. However, in this study, we used the Medical Coping Modes Questionnaire to select the informed person, which potentially decreased negative effects on the psychological vulnerable informed person. Also, we used the SPIKES strategy to disclose the cancer diagnosis, which helped to avoid a significant change on the informed person’s psychological and social functions. Although in the early stage after the cancer diagnosis was disclosed, most of the informed persons were not able to accept the reality right away, however, with a carefully preparation instructed by the SPIKES strategy, we avoided bringing unnecessary distress and anxiety to the informed person during the cancer diagnosis disclosure. We helped the informed person to overcome the stages of the negative psychological emotions (e.g., “tumor psychological shock period”, which was characterized by obvious anxiety, fear, and other negative emotions [30
]; the stage of defense and denial which was characterized by fear of death, being scared of radiation, chemotherapy, and surgery, and worrying about medical costs [31
]; and the stage of reluctant acceptance, which was characterized by the acceptance of their roles as cancer patients or the caregivers of cancer patients [32
]) with a positive attitude, thus the informed person was able to transit through the stages of negative psychological emotion within a short period.
Furthermore, the tailored psychological interventions improved the psychological and social function of the informed person, thus increasing the quality of life of the informed person. After taking multiple psychological interventions, such as giving pertinent and tailored psychological counseling, the informed person got out from the “tumor psychological shock period” promptly and developed trust in the health care providers. Also, connecting the informed person with the cancer group helped them to develop confidence to fight with cancer. The group activities which launched on a regular basis also offered them an opportunity to exchange their experiences and provided them a chance to share and solve their confusions toward cancer treatments. Furthermore, they provided ‘talking treatment’ service and spiritual support helped the informed person to form a positive belief towards death. It also provided us with valuable opportunities to be aware of and prevent multiple predictable accidents (e.g., suicides).
Due to the limitation of time and resources, this study had several limitations. First, the sample was randomized from one chosen hospital in China, which may limit the result to be generalized to other settings. Second, this study was a quasi-experimental study which lacked a control group. This may not be able to eliminate the effect of confounders. Lastly, some of the caregivers were chosen to be informed about the cancer diagnosis in this study. This required more work when the diagnosis needed to be further disclosed to the patients, which may increase the workload of the health care team.