|Year : 2022 | Volume
| Issue : 1 | Page : 35-44
Construction and validation of palliative care nursing theory guidelines for patients with advanced cancer
C Vasantha Kalyani1, Kusum K Rohilla2, Amit Gupta3, Sweety Gupta4, Manoj Gupta4, Nirmal Matella5
1 College of Nursing, All India Institute of Medical Sciences, Deoghar, Jharkhand, India
2 College of Nursing, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India
3 Department of Surgery, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India
4 Department of Radiation Oncology, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India
5 Director, Art of Living, Rishikesh, Uttarakhand, India
|Date of Submission||30-Nov-2021|
|Date of Decision||03-Jan-2022|
|Date of Acceptance||09-Mar-2022|
|Date of Web Publication||31-Mar-2022|
Kusum K Rohilla
PhD Scholar, College of Nursing, All India Institute of Medical Sciences, Rishikesh, Uttarakhand
Source of Support: None, Conflict of Interest: None
Background: Globally, there are many patients suffering from advanced cancers. There is a limited structured theoretical framework available for providing palliative care to these patients.
Objectives: We aimed to construct and validate palliative care nursing theory guidelines to provide better palliative services to patients with advanced cancer.
Materials and Methods: This study was conducted in Departments of Surgery and Radiation Oncology at the All India Institute of Medical Sciences, Rishikesh. In the present study, we used mixed-method design in which both qualitative and quantitative methods were used. In the qualitative study, exploratory surveys were used to derive themes using directed content analysis. We used the prospective cohort methods in the quantitative study. We tested the palliative care nursing theory on 80 patients with advanced gallbladder cancer and their caregivers for 6 months using the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QOL) scale and assessed the survival outcomes.
Results: Between July 2019 and Dec 2019, we enrolled 25 patients in the qualitative study. Four concepts of palliative care nursing theory were derived, that is, symptomatic management, problem-solving counseling, yoga and meditation, and family or caregiver involvement. Out of these, we developed a conceptual framework and palliative care nursing theory. In the subsequent quantitative study, we then tested this palliative care nursing theory on 80 patients (40 in the interventional group and 40 in the control group) with advanced cancer who were receiving palliative treatment. We provided care according to the palliative care nursing theory guidelines to the patients in the interventional group and found that this resulted in a significant benefit for both overall survival and quality of life (P = 0.0001; 95% confidence interval [CI], 5.97–87.82).
Conclusion: Our validated palliative care nursing theory is a structured and well-designed tool to provide comprehensive palliative care to patients with cancer. This can guide palliative care teams to provide better palliative care to patients and their families.
Keywords: Construction, gallbladder cancer, palliative care, palliative care nursing theory, quality of life, validation
|How to cite this article:|
Kalyani C V, Rohilla KK, Gupta A, Gupta S, Gupta M, Matella N. Construction and validation of palliative care nursing theory guidelines for patients with advanced cancer. Cancer Res Stat Treat 2022;5:35-44
|How to cite this URL:|
Kalyani C V, Rohilla KK, Gupta A, Gupta S, Gupta M, Matella N. Construction and validation of palliative care nursing theory guidelines for patients with advanced cancer. Cancer Res Stat Treat [serial online] 2022 [cited 2022 May 21];5:35-44. Available from: https://www.crstonline.com/text.asp?2022/5/1/35/341238
| Introduction|| |
The World Health Organization (WHO) defines palliative care (2008) as an approach to improving the quality of life (QOL) of chronically ill patients with any life-threatening conditions and their family members. The National Consensus Project (2006) developed palliative care guidelines which emphasize the four domains, that is, physical, social, spiritual, and family health, while delivering palliative care to any chronically ill patient.
Advanced cancer has a major impact on the QOL of patients and their families.,, Patients with advanced cancer face a lot of physical and mental problems including disease-related symptoms, anxiety, and sleep disturbances.,, Family members of the patient with cancer also suffer along with the patients. They face problems like a lack of knowledge regarding the disease and its prognosis, and economic problems. Therefore, patients with advanced cancer who are receiving treatment with palliative intent, as well as their family members have an impaired QOL and poor physical and mental health. Another major gap is the lack of structural palliative framework to identify the needs of patients with cancer and family.
Global Cancer Observatory: Cancer Today (GLOBOCAN) 2020 data showed that in Gangetic belt, gallbladder cancer is the most prevalent cancer. Majority (60%) of patients who suffer from gallbladder cancer are often asymptomatic and present to health-care facilities in the advanced stage., Treatment options available for patients with advanced gallbladder cancer are limited and include either palliative radiation therapy or chemotherapy. Advanced gallbladder cancer patients survival outcomes are limited, and reported only 5% after 1-year of their diagnosis., Hence, the main purpose of our study was to explore the needs of patients with advanced gallbladder cancer who were receiving therapy with palliative intent and their families and to design and validate palliative care nursing theory for palliative patients and their caregivers.
| Materials and Methods|| |
General Study Details
This was a mixed-method study that was conducted from July 2019 to July 2020 in the Departments of Surgery and Radiation Oncology at the All India Institute of Medical Sciences, Rishikesh, India. Ethical approval was obtained from the Institute Ethical Committee (AIIMS/IEC/19/912 on dated 07/19/2019) [Supplementary Appendix 1]. The present study was funded by Uttarakhand State Council of Science and Technology (UCS &T/R & D-03/20-21/19062), Dehradun. The study was registered with the Clinical Trials Registry-India, CTRI/2021/01/030791.Written informed consent was obtained from each study participant and their caregiver, and their anonymity and confidentiality were maintained throughout the study. The study was conducted according to the ethical guidelines outlined in the Declaration of Helsinki, Good Clinical Practice Guidelines, and the Indian Council of Medical Research guidelines.
For the qualitative study, we included patients who had been diagnosed with advanced cancer and were receiving palliative intent treatment. Participants had to be over 18 years old and willing to participate in the study. For the quantitative study, we included patients who had been recently diagnosed with advanced stage gallbladder cancer (staging and grading of gallbladder cancer were performed according to the American Joint Committee on Cancer [AJCC] staging system, eighth guidelines), age more than 18 years, and who were ready to participate in the study. We excluded persons with any mental disabilities and those who did not have caregivers.
The primary objective was to construct palliative care nursing theory guidelines to provide palliative care to patients with advanced cancer. Our secondary objective was to validate these palliative care nursing theory guidelines in patients with advanced gallbladder cancer.
We used both qualitative and quantitative approaches. The qualitative research tools consisted of evaluation of the biodemographic variables, that is, age, gender, marital status, Eastern Cooperative Oncology Group (ECOG) performance, and treatment status, and a structured questionnaire with 18 items (showing excellent reliability [r = 0.92]). The quantitative research tools consisted of biodemographic variables, that is, age, gender, marital status, distance from the hospital care facility, stage, and symptoms duration, and the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QOL) scale and living status. In the qualitative apart of the study, we used the direct content analysis method to collect information from each participant [Table 1].
|Table 1: Biodemographic data of patients (n=25) in the qualitative study|
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The data collection tools used for the qualitative study were 18 semi-structured, open-ended questions to collect data from each patient and their caregivers. The data collection was performed by conducting a personal interview, as described below. Qualitative data analysis was done after each interview. The researcher transcribed the recorded interview word for word and then checked its accuracy and similarity to the recorded tapes. A primary code (need, problems, or common symptoms) was derived for each area, and then, four themes (symptomatic management, problem-solving counseling, yoga and meditation, and family or caregiver involvement) and eight subthemes (general needs, special needs, and problems faced by patients, etc.) were extracted by using direct content analysis [Table 1].
In the quantitative part, we used the prospective cohort design to collect information on the theoretical framework for palliative care nursing theory, that is, its effectiveness, feasibility, and application. The tools used in the quantitative study consisted of questions regarding the sociodemographic variables, clinical profile, palliative care treatment, and QOL by the EORTC QOL. After gathering the subthemes, the themes were extracted and drawn into a conceptual framework for the palliative care nursing theory [Table 1]. By following the palliative care nursing theory, palliative care was provided to 80 patients (40 in the experimental group and 40 in the control group) and their caregivers [Table 2].
Phases of Palliative Care Nursing Theory Development
Phase I: Qualitative data were collected by conducting personal interviews using 18 semi-structured interview questions, which were developed by an extensive review of the literature and experts' suggestions., The study participants' behavior was observed and recorded by the researchers. To obtain reliable information, the researchers developed close and direct relationships with each patient and their caregiver by conducting an informal session, followed by the formal interview session. The mean interview duration was 45 min (range, 30–60 min). All interviews were recorded and then transcribed verbatim. The patients and their caregivers were asked the following questions during the interviews: “What does cancer mean to you?” “What does palliative care mean to you?” “Did you face difficulties related to cancer diagnosis and its treatment?” “What is your attitude toward cancer management done in hospital?” “How does cancer affect your life as a whole?” “How do you manage physical, social, and spiritual well-being during this phase?” “What education did you and your family/caregiver receive related to cancer and how does it affect your and your family's social life?” At the end of each interview, the researchers could add something by asking the following question: “Is there anything else left that you feel is relevant and would like to add?” The structured questionnaire was validated by 11 experts in the field of oncology and the inter-rater reliable score showed excellent reliability (r = 0.92).
Phase II: From the four derived themes, that is, symptomatic management, problem-solving counseling, yoga and meditation, and family or caregiver involvement, palliative care concepts were developed. Out of these concepts, a conceptual framework was prepared and palliative care nursing theory was developed.
Phase III: Palliative care nursing theory was tested on 80 advanced cancer patients (40 in the interventional group and 40 in the control group) and their caregivers. Palliative care was provided to the patients in the interventional group by following the palliative care nursing theory, and the patients in the control group received routine care. After 6 months, quantitative data were again collected through a structured personal interview of each participant and their caregiver. The quantitative data collection tools used in this study were validated by experts in the field of oncology and showed excellent inter-rater reliability (r = 0.90) [Table 2].
For the qualitative study, sample size calculation was done by using Raosoft software, that is, with a prevalence (p) value of 0.005, a minimum sample size of 30 was calculated using the purposive sampling technique. Out of 30 participants, final data were collected from 25 patients and their caregivers. For the quantitative study, sample size was calculated by using the Cochrane formula in which the sample size was calculated using prevalence, that is, P = 0.005, q = (1 − p), that is, q = 0.095, and degree of freedom, that is, d2 = 0.05 values by using purposive sampling technique. We estimated a sample size of 80 patients with advanced gallbladder cancer and their caregivers, who would be recruited over 6 months. Qualitative and quantitative data analyses were done by using the Statistical Package for the Social Sciences (IBM Corp. released 2015, IBM SPSS Statistics for Windows, version 23.0; IBM Corp., Armonk, NY, USA). Qualitative data analysis was done using Maxqda software. For the qualitative study, frequency and percentage were calculated to extract the subthemes and themes for palliative care nursing theory. For the quantitative study, descriptive statistics, that is, frequencies, percentage, and ranking and inferential statistics, that is, odds ratio, were used to check the efficacy of palliative care nursing model using P < 0.05 as the level of significance.
| Results|| |
Between July 2019 and July 2020, we enrolled 30 patients in the qualitative study; 85 patients were recruited for testing the palliative care theory. The status of five (16%) patients in the qualitative study and five (5%) in the quantitative study were either lost to follow-up or their disease status had not been documented. Of the 25 patients in the qualitative study, the majority were women (75%), married (90%), and had an ECOG performance score between 2 and 3 (40% in each). [Figure 1] shows our patient recruitment chart. Four main concepts of palliative care were derived, that is, symptomatic management, problem-solving counseling, yoga and meditation, and family or caregiver involvement [Table 1].
Phase I: Theme of Palliative Care Nursing
Symptomatic management: Cancer affects the physical health of patients. Symptomatic management consists of two main subthemes, “general needs” and “special needs.” For participants in the present study, vital needs such as water, food, and defecation were also affected by the advanced cancer. Ten participants said, “Cancer has suppressed my appetite. I am feeling lethargic.” Five participants said, “I am having continuous itching in my whole body.” Additionally, patients with advanced cancer have some special needs. Nine participants said, “PTBD (percutaneous transhepatic biliary drainage) tube needs careful handling, so I faced difficulty in moving about in bed and also while walking.” Eight participants said, “I am suffering from continuous pain in the epigastric region. This pain will take my life.”
Problem-solving counseling: The problem-solving counseling theme helps in assessing the patients' problems during advanced stage cancer and providing appropriate counseling. This theme consists of two subthemes: “assessing the problems faced by patients” and “counseling to help them out”. In this theme, there were various problems reported by participants. Some participants and family members said, “I am facing problems related to my cancer diagnosis, and I do not know the treatment options for me and the outcomes of that treatment.” Some participants and family members said, “I got counselling regarding my diagnosis of cancer only. I need more information regarding treatment options and the outcomes.” Two participants said, “Initially the palliative team had a discussion regarding my diagnosis of cancer. But now, they are discussing very little. I need more explanation about my status of cancer and its treatment outcome.”
Yoga and meditation: The theme of yoga and meditation derived from this study is a very important mechanism to maintain the mental health of patients and their family members. This theme helps in solving the problem of sleep deprivation and reducing anxiety related to the disease and its treatment among patients and family members. The theme consists of two subthemes: “factors affecting mental health” and “factors reducing mental stress.” For the subtheme factors affecting mental health, participants and their family members reported that a major factor affecting their mental health was sleep deprivation because of loss of privacy as well as disease symptoms.
A participant reported, “Since I was admitted in this ward, I have been unable to get sound sleep during the night because of pain and a lot of disturbance in my cabin.”
For the subtheme factors reducing mental stress, participants and their family members reported that major factors which helped in reducing mental stress were mediation and/or sometimes yoga. The participants and family members reported, “By chanting 'Om', my heart feels light.” A few participants and family members reported, “When I close my eyes to meditate, I feel relaxed and more energetic.”
Family or caregiver involvement: Family members' involvement helps in gaining the confidence of both patients and family members. This theme mainly consists of two subthemes: “Patient's satisfaction” and “Family had more confidence in the health system.” For the subtheme patient's satisfaction, participants felt more satisfied with the healthcare services as all their health issues were discussed with their family members. The participants reported, “I feel happy when all discussion regarding my disease is done in the presence of my family members.” For the subtheme family had more confidence in the health system, family members trusted the health services as they were fully involved in the decision-making regarding their patient treatment choices. Few families' members reported, “I have full confidence and am satisfied by the health services provided to my patient” [Figure 2].
Phase II: Palliative Care Nursing Theory Development
Designing of a conceptual system: A conceptual model provides structure for organizing various ideas into a meaningful palliative care plan. This conceptual model consists of five important concepts, that is, palliative care, patients and caregivers, and physical, socioeconomic, and spiritual factors. The National Consensus Project (2006) emphasized the importance of all four concepts of palliative care, that is, physical, social, spiritual, and family health, while delivering palliative care to chronically ill patients; it did not explain much about these concepts. We, therefore, performed a comprehensive literature review and built this conceptual framework for palliative care.
Process of development of concepts: Organization of reference points to address palliative care can lead to the development of well-defined concepts. We collected the qualitative data from 25 patients receiving palliative care; from the analysis of the palliative care research, we identified five main concepts, that is, physical, socioeconomic, and spiritual factors, and patient and caregiver [Figure 3].
Knowledge of these concepts is used by the palliative care nurses and other members of the palliative care team to plan appropriate interactions according to the palliative care needs of the patients and their caregivers. In addition, these concepts also provide ideas for further research in palliative care.
Theory of palliative care nursing: The goal of palliative care nursing theory is to identify, plan, and provide palliative care in such a way that patients and their caregivers achieve a good QOL after the diagnosis of a deadly disease. The five concepts which were selected from the palliative care system (physical, socioeconomic, and spiritual factors, and patient and caregiver) were incorporated into a palliative care nursing theory.
Palliative care nursing theory: A palliative care nursing theory was developed that presented the process by which the various contributing factors affected the individuals involved, that is, patient, caregiver, and nurse [Figure 3]. Factors like physical, socioeconomic, and spiritual have a strong impact on patients as well as caregivers, affecting different domains of health. Contributing factors for nurses providing palliative care to patients included education for palliative care, empathy, communication, and cost-effective care. All these factors should be considered while providing palliative care to patients and their caregivers.
Interaction: A palliative care nurse should have the knowledge and skill to identify the contributing factors, their interaction, and should be able to communicate with other palliative team members to provide holistic palliative care to patients and their caregivers.
QOL: QOL is assessed by asking questions related to physical, mental, social, and psychological health to patients and caregivers. When all contributing factors related to palliative care of patients and caregivers are addressed with appropriate interventions, patients and caregivers have a good QOL. Leaving even one factor unaddressed leads to poor QOL and the patient then goes through the same cycle starting from the initial step of palliative care nursing theory [Figure 4].
Phase III: Testing of the Palliative Care Nursing Theory
To test and validate the palliative care nursing theory, we provided problem-solving counseling, symptom management, and bhastrika pranayama (breathing exercise in which rapid and forceful inhalation and exhalation occur) three cycles per day to 80 patients with advanced gallbladder cancer who were receiving palliative care at the All India Institute of Medical Sciences, Rishikesh, India. For the caregivers, we provided problem-solving counseling, education regarding the care of the percutaneous transhepatic biliary drainage (PTBD) tube, and sudershan kriya (advanced rhythmic and cyclical breathing with slow, medium, and fast cycles) each day [Table 2].
The majority of patients were young adults (31–40 years), women (78%), belonging to rural areas (64%), and married (93%), and their caregivers were illiterate (40%). The majority (75%) had been diagnosed with stage IV cancer, and 44% had experienced disease-related symptoms for the preceding 3–6 months. The time gap from the onset of symptoms to the diagnosis of cancer was approximately 1 month in 97% of the patients. Most of the patients (55%) had not taken any alternative treatment for gallbladder cancer. Palliative care treatment was provided to the 80 patients with advanced gallbladder cancer as per the schedule. Most of the patients (55%) had not taken any alternative treatment for gallbladder cancer. Palliative care treatment was provided to the 40 experimental and 40 control group patients with advanced gallbladder cancer as per the schedule [Table 3] and [Table 4]. The majority of the patients (64%) received treatment for 6 months according to the following plan: continuous assessment and management of pain, that is, its management as per WHO analgesic ladder pattern, palliative chemotherapy, that is, gemcitabine in combination with cisplatin, PTBD tube insertion and daily care, supportive nursing care, yoga and meditation, and problem-solving counseling. The majority of the patients (64%) received treatment for 6 months according to the following plan: continuous assessment and management of pain, as per WHO analgesic ladder pattern, palliative chemotherapy, that is, gemcitabine in combination with cisplatin, PTBD tube insertion and daily care, supportive nursing care, yoga and meditation, and problem-solving counseling [Table 4]. About 37 out of 51 patients (72%) were alive after 6 months of treatment following palliative care nursing theory [Figure 5].
|Table 3: Biodemographic variables, clinical profile of patients, and quality of life of the study patients (n=80) in the quantitative study|
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|Table 4: Association of palliative care domains with the survival status of patients according to palliative care nursing theory (n1=40, n2=40)|
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The patients who received palliative care nursing theory had a significantly improved survival and significantly better QOL (P = 0.0001; 95% confidence interval [CI], 5.97–87.82), which supports the effectiveness of the palliative theory for advanced cancer patients [Figure 6].
|Figure 6: Quality of life of patients who were treated according to the palliative care nursing theory. PTBD = percutaneous transhepatic biliary drainage|
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| Discussion|| |
In the first phase of our study, we developed and validated the palliative care nursing theory. We discovered four main themes that need to be taken into account to provide good palliative care to patients and their families. The symptomatic needs of patients and their caregivers, including both general and special needs, should be explored and fulfilled. We found that patients and their caregivers suffered from reduced appetite, challenges to fulfill their basic needs, continuous fatigue, difficulties with daily activities, dependence on caregivers for ambulation and personal work, and so on. A study conducted in Cyprus on patients with advanced prostate cancer reported that the majority of participants experienced the symptoms of anxiety, depression, fear, and weakness. A study conducted in Texas on patients with chronic hepatitis demonstrated a negative impact of chronic disease on patients' overall QOL.
Counseling for problem-solving is a need of patients as well caregivers. Both had many unaddressed queries and recurrent doubts regarding the cancer diagnosis, treatment options, and the outcome of the planned treatment. Counseling helped in clearing the doubts and solving their social and economic issues. A study conducted in Japan on patients with breast cancer showed a significant effect of problem-solving counseling on patients' and caregivers' fear, worry, self-efficacy, and QOL. In our study, problem-solving counseling was provided to both patients and their family members regularly to address the issues faced by them during their treatment schedule.
Spiritual health must be assessed and interventions planned for participants and their families. A review article reported that yoga helped to reduce stress among patients with cancer and their family members, and it also modulated the response to any further stressors. In the present study, patients and family members were trained for yoga and meditation practices, and they routinely followed it and showed a good compliance for it.
Family/caregivers are an important domain in palliative care. Patients and caregivers have a direct and strong relationship with each other. If one is affected, the other is also affected. If patients are symptom free, their caregivers also experience less physical strain. A study conducted in Turkey reported cancer patient's family members always impacted their disease process i.e., starting from the diagnosis of cancer to various treatments by health accessibility to their patients and afford their treatment expenses, all of which greatly impacted patients' QOL. Another study conducted in China showed that if family member had a positive attitude toward any chronic disease, their patient always had a better QOL. In the present study, after the completion of 6 months of this study, the patients who had received palliative care as per the palliative care nursing theory were alive and had a good QOL.
We derived four concepts from the qualitative study, then framed the conceptual model for palliative care, and ultimately developed the palliative care nursing model. The majority of patients with gallbladder cancer present to the hospital in an advanced stage and require palliative treatment for symptoms.,
During the quantitative study, all patients had a good performance status, that is, an ECOG performance status less than 2, and received standardized treatment according to the patient's condition. All patients' symptoms were assessed and managed, and the patients had a good QOL. During the course of the treatment, caregivers were educated and counseled regularly regarding the homecare management of their patients.
The study was limited by the fact that we included only patients with advanced gallbladder cancer who were receiving palliative treatment. Thus, the results of the study may not be readily generalizable to patients with other malignancies.
Palliative care nursing theory developed in this study [Figure 4] is a specific theory for advanced cancer patients who are receiving palliative treatment. Till date, to the best of our knowledge, no palliative care nursing theory for patients receiving palliative intent therapy has been developed. Cancer has a strong impact on all domains of patients and their caregivers. The palliative care nursing theory that we have developed addresses all domains of palliative care. This validated palliative care nursing theory will help to guide, plan, and intervene standardized palliative care to each palliative patient.
| Conclusion|| |
The palliative care nursing theory, which we developed and tested on patients with advanced gallbladder cancer, is beneficial for patients with advanced cancer and their caregivers. The optimal application of palliative care nursing theory requires interdisciplinary team cooperation as well as regular quality improvement. Our vision for the future is that nurses will provide palliative care services according to the palliative care nursing theory globally. After diagnosis that a patient is to receive therapy with a palliative intent, the patient and their family members should receive palliative services as directed by the palliative care nursing model. Palliative care nursing theory will help to provide palliative services either in hospital, palliative care centers, or hospices. The evidence-based conceptual system of palliative care will be useful to deliver professional palliative care.
We extend our sincere thanks and acknowledgements to the participants and their caregivers of this study for cooperating throughout our data collection period.
Data sharing statement
Individual deidentified participant data (including data dictionaries) will be shared. Particular patient data will not be shared. The study protocol has been made available as a supplementary appendix, along with this article. The data will be made available up to 6 months after publication. Access to the data will be provided to any researcher who has any queries or in case the data are needed for further study. The data will be shared on request to Ms. Kusum K Rohilla, email ID: [email protected]
Conflicts of interest
There are no conflicts of interest.
| Supplementary Appendix 1: Study Protocol|| |
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]
[Table 1], [Table 2], [Table 3], [Table 4]