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Early Palliative Care on Coping Ability Research Paper

Benefits of Early Palliative Care on Coping Ability for Patients with Lung Cancer

Cancer is considered to be the most wide-spread and prevalent disease that often ends with lethal outcomes (American Lung Association, 2016). In the United States, lung cancer is the leading cause of deaths among all patients with cancer (American Lung Association, 2016). In 2016, more than 224,000 of new lung cancer cases are to be recorded in the USA, along with more than 158,000 instances of deaths (American Cancer Society, 2016). The numbers of cases increase, in comparison to the number of 212,584 of new cases and 156,176 of deaths recorded in 2013 (Centers for Disease Control and Prevention, 2013). Furthermore, lung cancer is the world’s most prevalent type of cancer with the global annual number of new cases that are amounting up to 1.8 million, while the annual number of deaths is reaching the level of 1.6 million incidents (American Lung Association, 2016). Globally, lung cancer is caused by tobacco use, causing 20% of all cancer deaths and being responsible for 70% of lung cancer deaths (World Health Organization, 2015). Due to the high proliferation of the disease and its high mortality rate, it seems necessary to study various care options. Moreover, this study is valuable in the early management of advanced stages with the great risk of the lethal outcome of the disease. Hence, the aim of the current paper is to present a research proposal for an evidence-based practice (EBP) project about early palliative care in advanced lung cancer.

Background

Lung cancer is a highly prevalent and deadly disease that has been the number one cancer killer in the USA, since 1987, when it surpassed breast cancer as the leading cause of death among women (American Lung Association, 2016). Only relatively recently researchers have become interested in amending the standard cancer care and supplementing it with early palliative care (Bauman & Temel, 2014). Palliative care is being considered as a supportive care method for all types of cancer diseases. Currently, palliative care is considered to be “an approach that improves the quality of life of patients and their families facing the problem associated with life-threatening illness” (Yoong et al., 2013, p. 283).

In turn, National Hospice and Palliative Care Organization (2016) defines palliative care, “as patient and family-centered care that optimizes quality of life by anticipating, preventing, and treating suffering” and involves “addressing physical, intellectual, emotional, social, and spiritual needs” of patients.
Thus, the American Society of Clinical Oncology has included an option of early introduction of palliative care for patients in advanced stages of the disease into standard care protocols. The latter also means that palliative care programs need the development and the refinement. Palliative care programs for patients with advanced lung cancer are suggested to include seven key components, relating to rapport building, symptoms, coping, understanding of the disease, available treatments, end-of-life planning, and family relations (Yoong et al., 2013).

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Overview of the available literature has showed that coping stage is an underevaluated component that needs further study. In order to distinguish the coping component as an outcome measure, it is, first, necessary to define it. World Health Organization (1999) defines coping, “as a capacity to respond and recover from something stressful” (p. 2). As a result, coping ability is understood as the capacity of the patient to utilize existing inner resources and support techniques, as well as external support, to be able to deal with the diagnosis, to develop a positive attitude about the treatment and its outcomes, and not to fall into severe depression or a state of despair. The latter is congruent with the concept of resilience that means the adaptation to the diagnosis (Molina et al., 2014).

Clinical Significance

The issues of early palliative care, in general, the coping constraint, in particular, as well as its implementation in the lung cancer care programs are of increased interest in the health care field. Previous studies by Greer et al. (2012) and Pirl et al. (2012) show a positive impact of the early palliative care on the depression predispositions, survival of lung cancer patients, their end-of-life care, and quality of life of their family. Alongside, they do not investigate the changes in the coping ability of patients. Instead, most studies of palliative care for lung cancer patients focus on one’s quality of life (Vanbutsele et al., 2015). Hence, the research proposal involves testing the hypothesis that early palliative care can positively affect coping abilities of patients with advanced lung cancer.

Purpose

The purpose of this research is to evaluate the impact of the early palliative care options, implemented into the general care program of advanced lung cancer patients on the improvement in coping ability. The PICOT question for this study is: in patients within the first three weeks of diagnosis with metastatic lung cancer, does the integration of palliative care added to the standard oncologic visits, as compared to the standard care at oncologic visits alone, strengthen the patient’s coping ability at the 8 weeks’ period. Accordingly, the quality of care, measured by patient’s perceptions and symptoms indices, constitute the independent variables, while the level of coping abilities, along with the quality of life values, serve as the dependent variables.

Literature Review

The literature review reveals the recent evidence regarding the palliative care of lung cancer patients, who are within their first weeks of metastatic diagnosis. Though many palliative care services around the world are sharing the same general aim, they are still different because of local healthcare structures, national health system components and varying cultures. Moreover, some aspects of providing the necessary support to patients in both specialist and generalist settings are discursive (Bausewein, Currow, & Johnson, 2016). Bausewein et al. (2016) describe the necessity of palliative care specialists with the high-level education, the corresponding staff, and various other resources for delivering the high-quality lung cancer treatment.

Bausewein et al. (2016) use a multidisciplinary approach to describe the term “palliative care” and go further with the access and support to its services. They explain how important and necessary palliative care is for people who suffer from cancer, drawing the particular attention to the primary type of lung cancer. The results of their qualitative study are mostly about the psychological and physical needs of such patients, who are suffering from the feeling of being intercepted by the society.

Another study by Zimmermann et al. (2014) reported on the tendency of the life quality decrease in patients with advanced cancer, closer to the end of their lives. In their study conducted at the Princess Margaret Cancer Center (Toronto, ON, Canada) between December 1, 2006, and February 28, 2011, they interviewed patients on the quality of their life, including spiritual well-being, satisfaction with medical care, and the medical interactions’ problems. Each month for 4 months, they measured the Quality of Life (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being [FACIT-Sp] scale and Quality of Life at the End of Life [QUAL-E]scale), symptom severity (Edmonton Symptom Assessment System[ESAS]), satisfaction with care (FAMCARE-P16), and problem with medical interaction (Cancer Rehabilitation Evaluation System Medical Interaction Subscale [CARES-MIS]). The results of the research have demonstrated that 461 patients have completed the baseline measures, both in control and intervention groups. After three months of studies, the change in the scores between the groups was barely visible. However, after the fourth month, those differences were significant for the intervention group. The scholars interpret the results they got, supporting early palliative care and stating about the promising findings on the quality of life measures (Zimmermann et al., 2014).

Other scientists have studied the positive effect of palliative care, mentioning the quality of life (QOL) and suffering relief of patients with advanced cancer (Irwin, Greer, Khatib, Temel, & Pirl, 2013). Closer to the end of their life, these patients have both psychological distress and physical pain. Consequently, they choose the aggressive methods of therapy to fight against cancer. The scholars, based on the literature review, promote palliative care, as a conceptualized need, in comparison to curative therapy of cancer. Their preliminary research suggests that early palliative care is beneficial for QOL, healthcare level, and general mood of the patients. Moreover, the clients with cancer of lungs have a potential to make their life longer. The main research findings of their literature review concern the influence of palliative care on patients with the advanced cancer survival chances (Irwin et al., 2013).

Similarly, Ferrell et al. (2015) highlighted the importance of palliative care within the frames of QOL concerns and the symptom management. They tested the effectiveness of the interdisciplinary palliative care that is offered to the patients with non-small cell lungs cancer (NSCLC). They were enrolled in the quasi-experimental study and divided into the control and intervention care groups. In addition to four educational sessions, in both groups QOL, symptoms, and psychological distress were assessed using surveys like the Functional Assessment of Cancer Therapy-Lung And the Lung Cancer Subscale, the 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being, and the Distress Thermometer. The primary analysis included 491 patients. The ones who received the interventions have demonstrated better QOL results. The general improvements of the results were the most noticeable within the earlier stages of the disease, as compared to the stage IV. The main conclusion of this research is that the interdisciplinary approach to palliative care, especially in the ambulatory settings, is necessary because it significantly improves the symptoms, QOL, and distress of patients with NSCLC (Ferrell et al., 2015).

It is also vital to investigate the questions of early palliative care and treatment options for the advanced cancer patients within the frames of the supportive care services. Greer, Jackson, Meier, and Temel (2013) took an innovative approach to their research, paying particular attention to the support of service providers toward the patients with this diagnosis. They described several factors to explain the existence of disparages in cancer care amid the category of vulnerable population, which is important during the early stages of cancer treatment and palliative care services.

One of the principal problems they discuss is the lack of professionals who are trained to conduct the clinical care and research. The scholars further mention about the evidence paucity to test and develop the interventions to support the patients. Finally, the scholars analyze the issue of limited financial resources that are also very important in the process of curing and alleviating cancer symptoms (Greer et al., 2013).

Due to the various misconceptions regarding the functions and the general role of care providers, who sometimes failed to identify patients’ psychological distress, many clients perceived the oncologists and their treatment with distrust and misunderstanding; approximately 30% of patients in palliative care settings experience some combination of anxiety, depression and coping disorders. Another study concerning the patients who were diagnosed with metastatic lung and colorectal cancers identified the clients’ insufficient understanding of the limited chemotherapy efficiency (Greer et al., 2013).

The researchers also mention the lack of communication between the oncologists and patients, as one of the primary barriers for clients to feel less stressed, hopeless, and anxious. In the case of early palliative care, patients have the opportunities to develop communication bridges with the members of their supportive teams. The latter can help patients to understand their illness better and to develop decision-making options regarding the treatment. In their literature review, scholars present the examples of different studies of the palliative care patients and their service providers. The results have demonstrated the fact of better QOL of those participants who are on the early stages of cancer treatment, presenting the intervention group (Greer et al., 2013).

Moreover, the scholars suggested the relationship between the two interventions during the early palliative care and general clinical outcomes. The caregivers in their practice should apply the mentioned approach, based on a specialized education and training support, in the process of their decision-making. This will result in better QOL and physical symptoms, and change the mood of patients. Caregivers have also discovered the necessity of illness understanding and knowledge of the patients, which would help them to cope with the behaviors of the latter. As a result, they can choose anticancer therapies or end-of-life care. Finally, the main conclusion of this research is that early palliative care with all the rules to follow may result in patients’ higher chances to survive (Greer et al., 2013).

Back et al. (2014) are among those scholars who conducted the qualitative study, further discovering the role of clinician in the early palliative care of patients with cancer. The authors are convinced that this type of care increases prognostic awareness of patients, provides better QOL, and may even lead to their survival. However, as they stressed, not much research was conducted on the methods of achieving this model in the early outpatient care field.

They examined the focus groups with the clinicians who participated in the early palliative care trial, dealing with the metastatic lung cancer. The results of the study discovered three main roles of clinicians: symptoms management function to improve physiological state, patients’ engagement role in the facilitation of emotions, and interpreting function, which is about the general communication between the patient and his oncologist. The received data of this study can serve as the framework for various training programs for palliative care clinicians.

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Theoretical Framework

The literature review implies the significance of constructing early palliative care, while focusing on the humanism values. Caring as the unitary healthcare phenomenon, reinforced by the humanistic position, is explained in the Watson’s theory of human caring. That is the combination enabling to improve the emotional constraint of treatment of advanced lung cancer patients. In particular, the theory relies on the caring concepts that are related to the human values: caritas processes, the transpersonal direction of caring, consciousness and caring-healing modalities (Watson, 2014, p. 323). In particular, caritas processes predispose uniting the efforts of health care providers and patients in finding the curing congruence and relief through caring passion and commitment to holistic care program of lung cancer. Moreover, the caritas suggest acceptance of positive and negative issues of the disease course that help to prevent the moral exhaustion of the patients and reinforce the coping abilities. In the case of the current intervention, the transpersonal direction of caring manifests in the palliative care implementation that stresses on the communication issues in treating one’s sufferings. Expanding caring–healing–loving consciousness of members of the intervention via cross-training and motivational conversations is another essential component of the project. Finally, the model points on the heart-centered caring attitude that in the case of patients with the life-threatening disease is more valuable than just the technocure orientation (Watson, 2014, p. 330). Altogether, the concepts can serve as the guidelines of the early palliative intervention program. In turn, it strengthens the patients’ coping abilities that reflect on the QOL, quicker anxiety overcoming, and, finally, creates a possibility to survive.

Methods

Research Design

The PICOT question shapes the need for the quantitative quasi-experimental research design. To detect the effect of early palliative care integration, the non-randomized control trial will be applied. The randomization procedure is not available because of the small number of cases of early diagnosis of advanced cancer and ethical issues. The latter means that the people just diagnosed with the cancer experience sufferings that may hinder them from participating. The researcher controls the effect of intervention, assigning patients to the intervention and control group, based on the clinical characteristics. The perspective analysis will start with baseline questionnaires of patients within just first three weeks of diagnosis with metastatic lung cancer. The same questionnaires will be given to the participants every week and at the end of 8 weeks of the program’s implementation. As the result, the overall health rating for each patient will be calculated and the significance of the changes will be tested.

Sample

The data from two groups of respondents will be accessed. The first intervention group will include 15 patients who received early palliative care within the first three weeks of diagnosis with metastatic lung cancer. The second one is a control group and will include 15 selected patients, who decided not to receive the early palliative care within the first three weeks of diagnosis with metastatic lung cancer. Inclusion criteria are the following: adult patient is within 3 weeks after diagnosis of metastatic lung cancer and can read and write in English. Exclusion criteria are adults with no diagnosis of metastatic lung cancer and who cannot read and write in English. Data will be collected via the weekly questionnaires, which respondents are asked to submit in the written form during the visits to oncologists or in their home settings. Respondents will receive these questionnaires from the research team members. Each member was responsible for the group of respondents that consisted of ten patients.
First of all, patients were familiarized with the survey via flyers and advertisements in the oncology departments. In those flyers and advertisings, participants were informed about the research purpose, its methods, and asked to connect with the researches, if they are willing to participate. Thereby, sample includes those participants, who expressed a desire to participate in the survey.

Setting

The project is supposed to involve the clinical and home settings that will be the most appropriate for the cancer patients. The EBP project will be conducted in the clinic, located in the urban area of the southeast United States. In order to get the IRB approval, the letter of permission from the chosen clinics was received before the study (Appendix A).

Research Protocol

The research preparation starts with the identification of participants. The respondents will be recruited via oncologists’ requests to their patients. In case the researcher plans to get clinical characteristics from the medical records or the oncologist information, referring to the 2016/17 ICD-10-CM Diagnosis Code (2016). The collaboration with the oncologists and therapists, and nurse practitioners of the clinics enable to plan the most convenient setting to submit the consent.

Further, the measurement procedures are based on the questionnaires with the open- and closed-ended questions. The five points of Likert scale are used in a part of the closed-ended questions, in order to measure the perceptions of patients of the key aspects of their health. According to the previous studies (Damm, Roeske, & Jacob, 2013; Zimmermann et al., 2014), the questionnaires provided by the Functional Assessment of Cancer Therapy Measurement System (FACIT, 2010) are appropriate to assess all the domains of the oncological care, including the quality of life and the spiritual well-being. They are based on the ordinal measurements information about the perceptions of care, symptoms, suffering, relief, and quantitative descriptions of the disease flow (Appendix C). The Ways of Coping Inventory (WAYS) is used for evaluation of coping skills (Appendix C). The questionnaire is found to be applicable to patients with lung cancer (Genç & Tan, 2011). The time analysis of the indices enables to provide the ratio measurements and obtain the significance indicators.

Therefore, the importance of the time series of questionnaires relies on the implementation of early palliative care into the general oncological care during the research period. Earlier, the palliative care was defined as a complex system of tools, the efficiency of which depends on the collaboration and positive communication (Greer et al., 2013; Ferrell et al., 2015). The stressful character of the disease determines the need for focusing on supportive services, in addition to the aggressive chemotherapy. Consequently, the early collaboration of the oncologist and the palliative care specialist should refer to the assistance in managing the psychological distress of the newly diagnosed patients. Greer et al. (2013) propose to use consultations about the disease management, coping abilities, and building relationships with the patient and its family, as the primary issues of early palliative care intervention. Conversations about the disease prognosis constitute another element that is leading to the increased awareness, and as a result coping. The weekly home visits of nurse professionals educated in oncology and early palliative care are expected to facilitate the spiritual well-being and the positive emotional status. Altogether, the mentioned issues of palliative care determine the coping component of the QOL. Hence, the project means at finding the evidence of improved coping skills with the help of the early palliative care intervention.

Ethical Issues

During the project, several ethical issues came up. Firstly, the advanced cancer patients are especially vulnerable to the humanistic and positive communication. Consequently, only patient-centered and empathetic attitude, preliminary explanation, and signing the informed consent enable the voluntary participation – an essential ethical issue of the nursing project (Appendix B). Further, it is necessary to protect participants from the unauthorized access to their personal data and provide confidentiality for everyone. Thereby, all of the datasets will be electronically coded. Each participant’s name will be coded, thus the only primary investigator is able to match code to the patient names. Participants from the first group will be coded by letter P and appropriate participant number, and participants from the second group will be coded by letter C and the appropriate participant number.

Analysis

Data Analysis Methods

Non-randomized selection procedure suggests extraneous variables, such as demography characteristics, health history, and social status that can threat internal validity. Statistical control of groups, using ANCOVA tools, will be performed. The nominal and ratios characteristics of demographic data, such as age, marital status, race, gender, city/county of residence, and educational level will be collected and analyzed, prior to the research phase. The SPSS software serves the option for the statistical analysis of the collected data in the questionnaires. Additionally, collected qualitative data is coded and sorted that allows conducting descriptive statistics analyses for both data ranges. In order to analyze the collected data, the following descriptive statistical tools are used: measures of central tendency, such as mode, median, and mean; and measures of spread, such as range, quartiles, absolute deviation, variance and standard deviation. Thereby, the data analysis results are summarized in tables, in graphs and in charts. Additionally, in order to discover whether there is a difference between the control group and groups of patients who received a palliative care inferential statistics with a t-test applied. It allows the comparison of the means of overall health of patients and obtains ratio results.

Timeline

The project timeline is illustrated in Table 1. Accordingly, the project consists of two phases that enable to organize and conduct the research. The first one is a preparing phase, which lasts for three weeks. During this time, the investigator should prepare the environment for the research, involve and arrange the cooperation with the oncologists and therapists. To provide the timely intervention, the procedure of the enrollment of participants should be organized on this stage. The second one refers to a research phase that is aimed at obtaining evidence of the early-introduced palliative care. It is a core part of the project, since data collection and analysis should be provided within this time period. This step provides the researcher with some measurable variables to detect the statistically significant results. Finally, after the data analysis, the final report should be generated.

Phase of the project

  • Week 1 Consult with the faculty staff and the project team about the organization and the schedule of interviewing.
    Meet with the chairs and the oncologists of the oncology departments to invite participants and arrange the timetable of questionnaires
  • Week 2 Enroll the participants for the intervention. Submit informed consents
    Set up programming environment.
  • Week 3Provide descriptive analysis of demographic data
    Distinguish sample units. Prepare blinding

Research phase

  • Week 1 Conduct baseline questionnaires
    Fulfill descriptive statistical analysis of baseline data questionnaire
    Control confounding variables
  • Weeks 2-6 Organize and conduct weekly questionnaires. Obtain descriptive statistics for every week
  • Week 7 Provide data analysis. Evaluate significance of changes
    Formulate study findings.
  • Week 8 Prepare a report.

Appendices

Appendix A: Institutional Review Board Application

Request for Exempt Review and Approval

The IRB is a binding contract approving a specific research methodology. Variations in the methodology by the researcher must be approved by the IRB. Failure to adhere to this policy will lead to disciplinary action up to and including failure of the class and/or dismissal from the university.

Application Status: (indicate if application is complete or is seeking conditional certification)

Study will be funded by:
Self/Other

Researcher (or family member) will receive compensation or potential financial benefits from conducting study or study outcomes.
Yes/No

Researcher (or family member) owns business or is in position of authority at location of research.
Yes/No

Basis for Exemption

  • Normal educational settings or practices
  • Anonymous educational testing. Note: Attach copies of test
  • Anonymous survey or interviews, unless interviews can cause risk
  • Observational studies of public behavior
  • Anonymous preexisting data

Review of Literature

Evaluation of institutions, programs, or agencies with no deviation from standard practice

Consumer acceptance studies

Research Information

Describe research including the following:

Overview of Study:

Cancer is among the most wide-spread and prevalent diseases with lethal outcomes all over the world (American Lung Association, 2016). In the United States of America (USA), lung cancer is the leading cause of death among all patients with cancer (American Lung Association, 2016). In 2016, more than 224,000 of new lung cancer cases are to be recorded in the USA along with more than 158,000 instances of death (American Cancer Society, 2016). The numbers represent an increase in comparison to the number of 212,584 new cases and 156,176 deaths recorded in 2013 (Centers for Disease Control and Prevention, 2013). Moreover, lung cancer is the world’s most prevalent type of cancer with the global annual number of new cases amounting up to 1.8 million, while the annual number of deaths reaching the level of 1.6 million incidents (American Lung Association, 2016). Globally, lung cancer is caused mostly by tobacco use, causing 20% of all cancer deaths and being responsible for 70% of lung cancer deaths (World Health Organization, 2015). Because of the high proliferation of the disease and its high mortality rate, it seems necessary to study various care options. Moreover, this study is even more important for the advanced stages because of the high chance of the lethal outcome of the disease.

The research will contribute to the evaluation of the impact of the early-introduced palliative care constraint into the general care program of advanced lung cancer patients on their coping ability. Accordingly, the hypothesis is that early palliative care can positively affect coping abilities of patients with advanced lung cancer. In this case, the researchers consider a palliative care as the most appropriate supplementary care method (Bauman & Temel, 2014). It manifests in preventing and addressing physical, psychological, and social problems, related with the lung cancer.

Research questions:

In cancer patients within the first three weeks of diagnosis with metastasis (P), how does the integration of palliative care within the oncologic visits (I) as compared to standard care with oncologic visits (C) strengthen the coping ability of the patient (O) over 8 weeks (T).

Research methodology:

The quantitative quasi-experimental research design will be used. To detect the effect of early palliative care integration, the non-randomized control trial will be applied. The researcher controls the effect of intervention by assigning patients to the intervention and control group based on the clinical characteristics. The perspective descriptive statistical analysis will be based on the scaled variables of the weekly questionnaires

Research purpose:

The purpose of the research is to study the impact of introducing the early palliative care options into the general care program of advanced lung cancer patients on improving of the patients’ coping abilities.

What will be required of study participants?

  • That the participant is above the age of 18 years or is 18 years old
  • That the participant can read and write in English
  • That the patient has been diagnosed with metastatic lung cancer within 3 weeks
  • That the participants have signed the informed consent form

Exclusion criteria: adults with no diagnosis of metastatic lung cancer and who cannot read and write in English
Describe data source(s), if applicable.

Questionnaires

Explain your access to data source(s), if applicable.
The collaboration with the clinic and oncologists in particular will allow for access to the demographic data as required and based on the agreement as specified in the approval letter submitted to the management of the facility. The rest of data will be collected via quationnaires

Additional Forms Included in Application

  • Informed Consent. After receiving the approval from the regulatory institutions, the participants will be enrolled. Further, the sample units will be selected. On this stage, all patients that agreed to participate in the project will receive the consent forms. Each respondent should carefully read and sign three similar sample forms, which will be further provided to the institution Ethics Committee, the clinic, where the study is conducted, and to the researchers.
  • Institutional Approval. In order to start the project it is necessary to get approval from two regulatory institutions: University Ethics Committee and the health care facility, involved in the research. Documents that are necessary to submit, will include the following information: purpose of the research, population description, research methods and instruments.
  • Internal Studies. All data that will be collected from within University must include this completed (unsigned) form.
  • Survey and/or Data Collection Materials. The exact survey and survey link (if applicable) or other data collection method must be included with the application.
  • Recruitment Materials. The exact recruitment materials and/or wording for all participant contact and recruitment must be included in the application.
  • Conflict of Interest. See section on Funding and Conflict of Interest to determine if form is needed.

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Research Assistant or Proxy Agreement

This is included when the primary investigator will not be the one collecting data.

Researcher Agreement

The researcher agrees to the following:

The information in the IRB Application is true and complete.Any modification in study members or data collection sites will be communicated to the IRB immediately. Data collection will be placed on hold until IRB confirms approval of the change.

Any modification to the process will be communicated to the IRB prior to changing the approved study. Data collection will be placed on hold until IRB confirms approval of the change.Any possible or clear adverse events occurring during the study will be immediately communicated to the Dissertation Chair/Faculty Mentor and IRB.

Data collection will be placed on hold until the IRB approves the continuation of the study.Any risk to participants that develops during the study will be communicated to the Dissertation Chair/Faculty Mentor, IRB, and study participants. Data collection will be placed on hold until the IRB approves the continuation of the study.

Research will not commence until IRB Application is approved.

Failure to adhere to the researcher agreement terms may result in suspension of research and disciplinary action up to and including failure of the class and/or dismissal from the university.

Signature of Researcher

The Dissertation Chair / Faculty Mentor agrees to the following:

  • The information in the IRB Application is true and complete.
  • Chair/Mentor will review any substantive changes to the research process and notify the IRB for guidance.
  • Chair/Mentor will review and communicate to the IRB any adverse events occurring during the study.
  • Chair/Mentor will review research records produced and maintained by the researcher until final approval of the study is obtained.
  • Chair/Mentor will insure the IRB Application is completed before it is submitted.
  • Chair/Mentor will be responsible to insure the research follows university guidelines and policies as presented in the application.

Note: If approval for exempt status is denied, researcher may submit Expedited IRB Approval Form

You are being asked to take part in a research study to present a research proposal for an evidence-based practice (EBP) project about early palliative care in advanced Lung Cancer. We are asking you to take part because you are getting diagnose with metastatic Lung Cancer within three weeks. Please read this form carefully and ask any questions you may have before agreeing to take part in the study.

What the study is about: The purpose is to study the impact of introducing early palliative care into the general care program of advanced Lung Cancer patients to improve coping ability.

Study Procedure: A questionnaire, provided to you, will consist of questions focused on the following spheres: perceptions of care, symptoms, suffering, relief, causes, and quantitative descriptions of the disease flow.

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Risks: There are no risks in this study. You may decline to answer any or all questions and you may terminate your involvement at any time if you choose. Benefits: There will be no direct benefit of the participation in this study for you. However, I really hope that with the information collected throughout this study, the quality of patient care with advanced stages of Lung Cancer can be improved.

Confidentiality: Your responses to this questionnaire will be anonymous. Please do not write any identifying information on your survey. Every effort will be made by the researcher to preserve your confidentiality including:

  • Collected data will be coded and electronically recorded; only the principal investigator will be familiar with the names of participants.
  • Notes, surveys and any identifying participant information will be kept in a locked cabinet for files in the personal possession of the principal researcher.

Compensation: You will not get any compensation for the participation at the project.

Contact Information: If you have questions at any time about this study, or you experience adverse effects as the result of participating in this study, you may contact the Primary Investigator, please contact

Voluntary Participation: Your participation in this study is voluntary. It is up to you to decide whether or not to take part in this study. If you decide to take part in this study, you will be asked to sign a consent form. After you sign the consent form, you are still free to withdraw at any time and without giving a reason. Withdrawing from this study will not affect the relationship you have, if any, with the researcher. If you withdraw from the study before data collection is completed, your data will be returned to you or destroyed.

Consent

I have read and I understand the provided information and have had the opportunity to ask questions. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving a reason and without cost. I understand that I will be given a copy of this consent form. I voluntarily agree to take part in this study.

Participant’s signature ______________________________ Date __________
Investigator’s signature _____________________________ Date __________

Appendix C: Questionnaires

FACIT. FACIT-L (Version 4) is designated to assess the specific measures and symptoms of the lung cancer patients. The FACIT-Sp questionnaire is aimed at assess spiritual well-being of cancer patients. The FaCIT-TS assessment tool provides the measurable data about the treatment satisfaction. The FACIT-Pal provides the measures of assessing palliative care options. Accordingly, this tool will be applied to the intervention group at the start and in the end of trial period. All the templates are available for downloading at the FACIT Measurement System site (FACIT, 2010).

The Ways of Coping questionnaire is available as the work of Folkman and Lazarus (1988).

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