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June 2012 VOL 3, NO 3
Problems and Process in a Study Design—Lessons Learned
Carol Guarnieri, RN, MSN, FNP-C, AOCNS
Abstract: Healthcare professionals want to ensure that every patient receives quality care throughout the continuum of their cancer illness. In addition, many national organizations have challenged healthcare providers to provide comprehensive services to cancer survivors. Research indicates that long-term adverse outcomes for cancer survivors are more prevalent, serious, and persistent than previously known. As a result, survivorship care presents many new avenues for nursing research. In developing our survivorship program, an interdisciplinary team at our hospital developed an exploratory pilot research study to evaluate the impact of assessment, education, support, and guidance on patients’ quality of life and distress. The goal of the pilot study was to evaluate our interventions and make recommendations to expand our survivorship services to all cancer patients in our hospital system. We encountered several problems with implementing our study. This paper describes our research process and the problems we encountered with our study design and the revisions that were made in order to accrue patients and achieve our goals. A description of these challenges and the changes we made may assist others with their research endeavors.
It is estimated that nearly 12 million individuals in the United States are living with cancer.1 Cancer survivorship is defined as the experience of living with, through, and beyond cancer for both patients and the people in their lives who are impacted by the diagnosis. Survivorship encompasses the physical, psychological, emotional, social, spiritual, and economic aspects of life.2 Psychological distress, impaired organ function, sexual dysfunction, cosmetic changes, limitations in mobility, communication issues, and decreased cognition are among some of the problems faced by many cancer survivors. The economic impact of a cancer diagnosis can be an additional burden to cancer survivors through increased out-of-pocket medical expenses, changes in employment status, and decreased access to affordable health insurance.3
In addition to the physical and psychological effects of the disease and its treatment, living with cancer presents substantial life challenges to survivors and their families. Long-term adverse outcomes for cancer survivors may cause distress and negatively impact quality of life (QOL). The National Comprehensive Cancer Network (NCCN) has challenged healthcare providers to provide comprehensive services to cancer survivors and has provided evidence-based guidelines and tools to assist in improving outcomes and enhancing QOL.4 In the report from the Institute of Medicine, From Cancer Patient to Cancer Survivor: Lost in Transition, 10 recommendations were made to improve the QOL of cancer survivors.
The first recommendation is that healthcare providers, patient advocates, and other stakeholders should work together to raise awareness of the needs of cancer survivors, establish cancer survivorship as a distinct phase of cancer care, and act to ensure the delivery of appropriate survivorship care.3 Since care for survivors is a key component of a quality cancer program, leaders at Scottsdale Healthcare (SHC) wanted to develop a cancer survivorship program in response to these recommendations. SHC is a large community-based hospital system located adjacent to the Phoenix metropolitan area. An interdisciplinary team from the Virginia G. Piper Cancer Center (VGPCC) at SHC developed an exploratory research study to evaluate the impact of assessment, education, support, and guidance on the QOL and distress in head and neck cancer and lung cancer patients who had completed a minimum of 4 weeks of radiation therapy.
Evaluating the effects of this program on patient distress and QOL was needed to determine whether program modifications, revisions, and/or additional services were indicated in order to minimize distress and enhance QOL for all cancer survivors. After an evaluation of outcomes, modifications would be made as needed to improve implementation processes, identify gaps in available services, and estimate the financial resources and personnel necessary to expand and sustain a community-based survivorship program. The program would then be offered to all adult cancer survivors who contact the VGPCC for care.
REVIEW OF THE LITERATURE
Distress is defined by the NCCN as a multifactorial unpleasant emotional experience of a psychological (cognitive, behavioral, emotional), social, and/or spiritual nature that may interfere with the ability to cope effectively with cancer, its physical symptoms, and its treatment. Distress extends along a continuum, ranging from normal feelings of vulnerability, sadness, and fear to problems that can become disabling, such as depression, anxiety, panic, social isolation, and existential and spiritual crisis.4
Psychological distress in patients with cancer can negatively impact their QOL. According to Vachon, approximately one-third of cancer survivors report distressing symptoms that may range from sadness to debilitating depression.5 According to the National Cancer Institute, 44% of cancer survivors report some anxiety, with 23% reporting significant anxiety.6 The most common fear among cancer survivors is the fear of recurrence, ranging from 5% to 89%, depending on the type of cancer diagnosis, stage of cancer, and other factors.7
Quality of Life
QOL is defined by the conceptual framework based on research by Ferrell and colleagues and includes an individual’s perception of physical, psychological, social, and spiritual well-being.8 As the treatment of cancer has become more successful, the number of cancer survivors has risen. Long-term survival from cancer has brought QOL to the forefront as an issue in cancer survivorship. QOL is defined as an individual’s assessment of his or her own general well-being. A core concept of measuring QOL is obtaining self-assessment by the patient across multiple “domains,” or areas, of well-being. In order to assess QOL in cancer survivors, standardized, self-administered questionnaires are generally used. It is recommended that assessments be repeated at regular intervals over a period of time, focusing on function in physical, psychological, social, and spiritual domains.3
SURVIVORSHIP BY DISEASE SITE
Head and Neck Cancer
Head and neck cancers can have a profound impact on a survivor’s QOL. The head and neck region is important for the functions of eating and speech. Head and neck cancer survivors often undergo a combination of surgery, chemotherapy, and radiation. The combination of cancer and its treatment can leave a significant alteration in this area cosmetically, functionally, and socially. The treatment results in a variety of long-term effects such as xerostomia, loss of taste, dental decay/loss, and tissue loss resulting in disfigurement.9 Patients with head and neck cancer experience a variety of psychological symptoms and disorders of anxiety and depression, possibly at rates greater than those seen in patients with other types of cancer.10
According to a review by Goldstein and colleagues, QOL in head and neck cancer patients worsens during and shortly after treatment and then gradually improves, approaching baseline levels 12 months after diagnosis.11 This is consistent with the time frame of our intervention. An awareness of the type of issues experienced by head and neck cancer patients is vital for accurate assessment and effective intervention. By identifying needs early on, we can better understand the survivor’s concerns, provide education, and make appropriate referrals. A review of the head and neck cancer studies by Pandey et al and Karnell et al identified that anxiety, depression, family distress, social distress, and impact on activities of daily living all resulted from a cancer diagnosis.12,13
Lung cancer patients have been identified through multiple studies as having high levels of distress.14-16 Symptoms that increase distress that have repeatedly been identified for lung cancer patients include fatigue, pain, cough, dyspnea, sleep disruptions, decreased appetite, anxiety, depression, and problems with family relationships and physical and cognitive functioning. The 2 most reported symptoms are fatigue and pain.17,18 The lung cancer research clearly demonstrates the serious nature of distress and the impact on QOL. In their study of 333 patients in a multidisciplinary lung cancer clinic, Graves and colleagues utilized the distress tool and identified clinically significant distress in 61.6% of the patients.14 Sarna and colleagues describe serious disruptions in the psychological and social aspects of QOL in 217 women with non–small cell lung cancer who were between 6 months and 5 years out from diagnosis.18
The conceptual framework used in this study was the QOL model for cancer survivors developed by Ferrell and Grant at the City of Hope (COH) Medical Center.19 QOL is defined as a multidimensional concept consisting of 4 domains that include physical, psychological, social, and spiritual well-being. The concept is based on the belief that each domain contributes to an individual’s perception of overall QOL.3 Results from the COH QOL questionnaire were going to provide the foundation for patient-directed goal setting focusing on the 4 domains of QOL.
This study evaluated the impact of assessment, education, support, and guidance on QOL and distress in head and neck cancer and lung cancer patients who had completed a minimum of 4 weeks of radiation therapy at SHC.
This study employed a nonexperimental, ex - ploratory, descriptive design. The study was conducted in an outpatient radiation center in a large Southwestern community-based hospital. The sample for the study consisted of adult oncology patients with a lung cancer or head and neck cancer diagnosis receiving radiation therapy for at least 4 weeks. An anticipated enrollment in the study was 90 participants, based on the number of head and neck cancer and lung cancer patients treated at the hospital.
Inclusion criteria included those older than 18 years, who were able to speak, read, write, and understand English, had a primary diagnosis of lung cancer or head and neck cancer, and were able to complete a minimum of 4 weeks of radiation therapy. Patients were identified by the nursing staff in radiation oncology.
Patients who met the inclusion criteria were asked to consider participation in the study. If the patient agreed, he or she was enrolled into the study. The COH QOL for Cancer Survivors and NCCN Distress surveys with an attached cover letter were distributed by mail 1 month after the completion of radiation therapy. Patients were contacted by phone to schedule the first meeting with the case management team and to answer any questions concerning completion of the questionnaires.
Each participant was assigned a survivorship advanced practice team. Program team members were master’s-prepared certified oncology nurses and/or master’s-prepared licensed medical social workers and were investigators in this study. After completion of the assessment tools described, participants met with a team member to review the results of the assessment tools and work together to define patient-specific goals. Survivors were to work with their primary team member to develop an action plan to help address their concerns and goals. Referrals to the appropriate services and providers would be initiated as needed.
Additional didactic information addressing common issues facing cancer survivors was to be provided at each patient contact. Topics included maintaining personal health records, the medical treatment summary and follow-up plan, common physical and emotional concerns, and practical matters. Patients also received a LIVESTRONG ™ Survivorship Notebook and other educational materials as determined by participant needs.
Participant contact with a primary team member would occur on a monthly basis, and more or less frequently as indicated through ongoing assessment of patient needs. The additional contacts were conducted in person or via phone calls. In addition to individualized case management services, participants were offered personalized education, psychosocial support and referrals, and community education seminars.
Collection of demographic information and QOL and Distress surveys were to be completed 1 month posttreatment, and they were to be repeated at 3 and 6 months after completion of radiation therapy. Surveys were to be either mailed to patients for completion or completed in person.
Data collected in the study were to be reported in the aggregate without patient-identifying information to protect anonymity. The study was approved by the Institutional Review Board at SHC, where the investigators were employed.
DATA ANALYSIS PLAN
Data were to be entered using a double entry into a customized Excel spreadsheet. Discrepancies were to be checked and corrected. All data collected in this study were going to be documented using summary tables. Descriptive statistics were to be provided for each variable measured, by group and measurement period. Statistics were to include sample size, arithmetic mean, median, standard deviation, and minimum and maximum for continuous variables. Categorical variables were going to be summarized using frequencies and percentages. Geometric means were to be calculated for variables that are non-normally distributed. Statistical analyses were to be performed using SPSS version 16.0.
The primary analysis was to compare Distress Thermometer and QOL scores at 6 months across groups. Preliminary analysis was to be conducted to assess the degree of intercorrelation among the domain scores on the QOL instrument and the single score on the Distress Thermometer.
A major problem encountered was that our patient accrual was very slow. Patients chose not to participate for a variety of reasons. Our refusal rate was over 60%. Even for the patients who consented, not 1 patient was able to complete the study requirements. We chose this population of lung and head and neck cancer patients because we thought that these patients could benefit from extra assistance and education. However, our patients stated they did not have the energy to complete the forms or attend the meetings. Both were too burdensome and taxing. In our initial study, we also attempted to study a patient population with whom we did not have an established professional relationship. In the redesign, we chose patients according to our subspecialties area. This allowed the advanced practice nurse (APN) to develop a rapport with the patient before inviting him/her to participate in the study. We felt that developing a trusting relationship prior to an invitation to participate in the study also enhanced our recruitment process.
Need for Study Revision
The study has since been through several revisions. Through this process we have learned several lessons. First, the burden of a new diagnosis and treatment for severely ill patients, along with the burden of completing study questionnaires, was overwhelming. We needed to simplify the study. To facilitate recruitment, we broadened the study to include all newly diagnosed patients. All patients who agree to participate are given the NCCN Distress tool and the COH QOL tool. Upon completion of the questionnaires, the APN meets with the patient and significant other(s) to identify areas of concern and establish goals. The APN continues to meet with the patient as necessary. After 3 months of interventions, the patient is given an evaluation form to complete, assessing whether the APN’s interventions and education were helpful. Implementing this simple and less- complicated design, we are continuing to recruit and maintain patients.
Cancer survivorship care represents a major area of research opportunities. In developing a survivorship program that encompasses the needs of our patients, this was our first attempt to conduct a research study. We learned that a simplified research design and less strict recruitment criteria were beneficial. With our current simplified design, we are recruiting and maintaining patients. One of our most important lessons was that research happens by persevering through obstacles and multiple revisions. Most importantly, through our persistent efforts, our goal remains to assist our patients in meeting their needs by providing individualized care to help minimize distress and improve their QOL.
American Cancer Society. Learn about cancer. www.cancer.org/Cancer/news/News/numberofuscancersurvivorsgrowing. Accessed January 5, 2012.
Clark EJ, Stovall EL, Leigh L, et al. Imperatives for quality cancer care: access, advocacy, action, and accountability. In: Scherr SL, ed. Self-Advocacy: A Cancer Survivor’s Handbook. Silver Spring, MD: National Coalition for Cancer Survivorship; 1996.
Hewitt M, Greenfield S, Stovall, E, eds. From Cancer Patient to Cancer Survivor: Lost in Transition. Washington, DC: The National Academies Press; 2005.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Distress Management. http://nccn.org/professionals/physician_gls/PDF/distress.pdf. Accessed January 7, 2012.
Vachon M. Psychosocial distress and coping after cancer treatment. Cancer Nurs. 2006;29(2 suppl):26-31.
National Cancer Institute. Anxiety disorder PDQ. www.cancer. gov/cancertopics/pdq/supportivecare/anxiety/healthprofes sional. 2008. Accessed February 5, 2009.
Alfano CM, Rowland JH. Recovery issues in cancer survivorship: a new challenge for supportive care. Cancer J. 2006;12:432-443.
Ferrell BR, Grant M, Dow KH. Quality of life model applied to cancer survivors. http://prc.coh.org/pdf/cancer_survivor_QOL.pdf. 2004. Accessed February 5, 2009.
Rogers SN, Ahad SA, Murphy AP. A structured review and theme analysis of papers published on ‘quality of life’ in head and neck cancer: 2000-2005. Oral Oncol. 2007;43:843-868.
Haman KL. Psychologic distress and head and neck cancer: part 1—review of the literature. J Support Oncol. 2008;6:155-163.
Goldstein DP, Hynds Karnell L, Christensen AJ, et al. Health-related quality of life profiles based on survivorship status for head and neck cancer patients. Head Neck. 2007;29: 221-229.
Pandey M, Devi N, Thomas B, et al. Distress overlaps with anxiety and depression in patients with head and neck cancer. Psychooncology. 2007;16:582-586.
Karnell L, Christensen AJ, Rosenthal EL, et al. Influence of social support on health-related quality of life outcomes in head and neck cancer survivors. Head Neck. 2007;29:143-146.
Graves KD, Arnold SM, Love CL, et al. Distress screening in a multidisciplinary lung cancer clinic: prevalence and predictors of clinically significant distress. Lung Cancer. 2007;55:215-224.
Logue AE, Gawiak CT, Houlihan N, et al. Development of a non-small cell lung cancer (NSCLC) survivorship program: baseline clinical characteristics and quality of life (QOL): PD5- 3-8. J Thoracic Oncol. 2007;2:S481.
Zabora J, BrintzenhofeSzoc K, Curbow B, et al. The prevalence of psychological distress by cancer site. Psychooncology. 2001;10:19-28.
Cooley ME, Short TH, Moriarty HJ. Symptom prevalence, distress, and change over time in adults receiving treatment for lung cancer. Psychooncology. 2003;12:694-708.
Sarna L, Brown JK, Cooley ME, et al. Quality of life and meaning of illness of women with lung cancer. Oncol Nurs Forum. 2005;32:E9-E19.
Ferrell BR, Grant M. Quality of life Patient/Cancer Survivor version. http://prc.coh.org/QOL-CS.pdf. Accessed February 12, 2009.