Kingdom of Saudi Arabia
KING SAUD UNIVERSITY
College of Medicine
Institutional Review Board
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Kingdom of Saudi Arabia
KING SAUD UNIVERSITY
College of Medicine
Institutional Review Board
Please, fill this page if the research proposal is submitted in English.
Research Title:
Does implementation of distress screening program in cancer services using distress thermometer scale improve patients outcomes including satisfaction,quality of life
Summary: (150 ‘ 200 words)
Research Problem: Distress in cancer patients is common, However, far less than 30% of cancer patients showing psychosocial problems are recognized in clinical settings by oncologists and thus referred to proper sources of psychological support. Recent literature has indicated the need for rapid evaluation of psychosocial issues secondary to cancer. However there is no available distress screening program for cancer patients in Saudi Arabia
Research Significance:To improve patient care through monitoring distress,By using NCCN distress management screening measure, which consisted of a Distress Thermometer (DT) and a problem checklist. The thermometer measures distress on a 0-10 scale and the problem checklist identifies more distress etiologies (such as practical, spiritual, physical, emotional and family problems). The NCCN guidelines suggest that patients complete the screening tools at each visit.
Research Objectives:
1-The primary objective of this study is to explore the effectiveness of the implementation of distress thermometer in respect of patients’ quality of life and satisfaction.
2- the secondary objective is to use DT as a tool for screening psychological distress in KKUH oncological setting.
Phase 1 will involve interviews with patients and staff to assess quality of life and satisfaction
Phase 2 will involve introducing the DT questionnaire to outpatients in oncological setting
Phase 3 will involve interviews with patients and staff to assess their DT experience and to gather their views on distress management in hospitals
Kingdom of Saudi Arabia
KING SAUD UNIVERSITY
College of Medicine
Institutional Review Board
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Research Project Proposal
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Please, type either in English or Arabic
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Investigators Names*
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First name indicates the Principal Investigator (PI). *
Second name is the co-investigator designated by the PI to assume all responsibilities,
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NOTE: For principal investigator from other college/hospital (outside KKUH) please provide contact details:
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Research Problem and Significance
‘ Research Problem:
This research tests the Distress Thermometer (DT) as an example of distress screening tools to explore its effect on patients’ outcomes, including psychosocial health, satisfaction, and quality of life.
‘ Research Significance:
Psychological distress is common among cancer patients (1’3), but far less than 30% of cancer patients showing psychosocial issues are diagnosed by oncologists and thus few receive appropriate treatment (4). There is currently no available distress screening program for cancer patients in Saudi Arabia.
Cancer and its associated distress can affect quality of life (QOL) greatly (5’7). This research aims to improve cancer patients’ care and quality of life at KKUH by implementing the Distress Thermometer (DT) and its problem checklist. The thermometer measures distress on a 0-10 scale and the problem checklist identifies more distress etiologies covering five domains (practical, spiritual, physical, emotional and family problems) (8).
The NCCN guidelines suggest that patients complete the screening tools at each visit, however, there is a debate wither screening for distress actually improves patients’ outcomes (9,10) while others question its benefit relative to exploiting resources (11’14)
1. Carlson LE, Angen M, Cullum J, Goodey E, Koopmans J, Lamont L, et al. High levels of untreated distress and fatigue in cancer patients. Br J Cancer [Internet]. 2004;90(12):2297’304. Available from: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2410292&tool=pmcentrez&rendertype=abstract
2. Zabora J, Brintzenhofeszoc K, Curbow B, Hooker C, Piantadosi S. The prevalence of psychological distress by cancer site. Psychooncology. 2001;10(1):19’28.
3. Fallowfield L, Ratcliffe D, Jenkins V, Saul J. Psychiatric morbidity and its recognition by doctors in patients with cancer. Br J Cancer [Internet]. 2001;84(8):1011’5. Available from: http://dx.doi.org/10.1054/bjoc.2001.1724
4. Gil F, Grassi L, Travado L, Tomamichel M, Gonzalez JR, Zanotti P, et al. Use of distress and depression thermometers to measure psychosocial morbidity among southern European cancer patients. Support Care Cancer. 2005;13(8):600’6.
5. Jacobsen PB, Ransom S. Implementation of NCCN distress management guidelines by member institutions. JNCCN J Natl Compr Cancer Netw. 2007;5(1):99’103.
6. Shim E-J, Mehnert A, Koyama A, Cho S-J, Inui H, Paik N-S, et al. Health-related quality of life in breast cancer: A cross-cultural survey of German, Japanese, and South Korean patients. Breast Cancer Res Treat [Internet]. 2006;99(3):341’50. Available from: http://link.springer.com/10.1007/s10549-006-9216-x
7. ”zalp E, Cankurtaran ES, Soyg”r H, Geyik P”, Jacobsen PB. Screening for psychological distress in Turkish cancer patients. Psychooncology. 2007;16(4):304’11.
8. Vitek L, Rosenzweig MQ, Stollings S. Distress in Patients With Cancer’: Definition, Assessment, and Suggested Interventions. 2007;11(3).
9. Carlson L, Waller A, Groff S, Zhong L, Bultz B. Online screening for distress, the 6th vital sign, in newly diagnosed oncology outpatients: randomised controlled trial of computerised vs personalised triage. Br J Cancer [Internet]. 2012;107(4):617’25. Available from: http://dx.doi.org/10.1038/bjc.2012.309
10. Blenkiron P, Brooks A, Dearden R, McVey J. Use of the distress thermometer to evaluate symptoms, outcome and satisfaction in a specialist psycho-oncology service. Gen Hosp Psychiatry [Internet]. 2014;36(6):607’12. Available from: http://dx.doi.org/10.1016/j.genhosppsych.2014.06.003
11. Coyne JC. Benefits of screening cancer patients for distress still not demonstrated. Psycho-Oncologie [Internet]. 2013;7(4):243’9. Available from: http://dx.doi.org/10.1038/bjc.2013.16
12. Coyne JC. Second thoughts about implementing routine screening of cancer patients for distress. Psycho-Oncologie. 2013;7(4):243’9.
13. Meijer A, Roseman M, Delisle VC, Milette K, Levis B, Syamchandra A, et al. Effects of screening for psychological distress on patient outcomes in cancer: A systematic review. J Psychosom Res [Internet]. 2013;75(1):1’17. Available from: http://dx.doi.org/10.1016/j.jpsychores.2013.01.012
14. Thombs BD, Coyne JC. Moving forward by moving back: Re-assessing guidelines for cancer distress screening. J Psychosom Res [Internet]. 2013;75(1):20’2. Available from: http://dx.doi.org/10.1016/j.jpsychores.2013.05.002
Research Objectives
1-The primary objective of this study is to explore the effectiveness of the implementation of distress thermometer in improving cancer patients outcome including quality of life and satisfaction at KKUH oncology clinics.
2- the secondary objective is to study the attitude of physicians and nurses towards using the distress thermometer before each consultation.
3- the secondary objective is to explore the effectiveness of using distress thermometer as a tool for screening psychological distress in KKUH oncological setting.
4- the secondary objective is to acknowledge the most common stressor affecting cancer patients at KKUH oncology clinics.
Literature review
The National Comprehensive Cancer Network (NCCN) defines Cancer-related distress as an emotionally unpleasant psychological (cognitive,behavioral, emotional), social, andor spiritual experience that might interfere with a patient’s ability to effectively cope with cancer, its physical symptoms, and its treatment. Distress extends along a continuum from common normal feelings of vulnerability, sadness and fear, to disabling problems, such as true depression, anxiety, panic and feeling isolated or in a spiritual crisis(1)
Distress in cancer patients is common(2)(3). An estimated 29.6%’43.4% of patients with cancer suffer from some form of psychological distress during their cancer journey(3).Between one-third and 40 percent of cancer patients may experience anxiety, distress or depression during their cancer journey (4). Distress has negative impacts on cancer care and outcomes, quality of life (QOL)(5)(6), treatment adherence (7), satisfaction with medical care and interactions (8), survival (9), and Can lead to patient suicide(10). Moreover, far less than 30% of cancer patients showing psychosocial problems are recognized in clinical settings by oncologists and thus referred to proper sources of psychological support(11)(12). Therefore Recent literature has indicated the need for rapid evaluation of psychosocial issues secondary to cancer (13).
Several instruments have been suggested as clinical tools for the identification of psychological distress, such as the Hospital and Anxiety Depression Scale (HADS)(14), the Brief Symptom Inventory(BSI) (15),and the Psychological Distress Inventory (PDI)(16). However, the time and effort required for administering, scoring, and interpreting these measures limit their use in clinico-oncological settings(17).
In the busy setting of cancer care, the need for an effective yet simple and brief screening method to detect distress in patients has become apparent. To address this need: The NCCN has developed the Distress Thermometer (DT) as a quick and efficient tool to screen for distress in cancer patients(18) (19).The thermometer measures distress on a 0-10 scale ,In addition to the Distress Thermometer, NCCN has created a Problem List (PL) that invites patients to read any of 34 issues grouped in five categories (practical problems, family problems, emotional problems, spiritual or religious concerns, and physical problems) and check possible reasons for the distress. The NCCN guidelines have recommended that all patients with cancer should be screened for distress and managed according to their level of distress. And suggest patients complete the screening tools at each visit(18).The Distress thermometer (DT) has been translated and validated for various cancer types worldwide(20), including Saudi Arabia [” ” ” ”].
Several studies were undertaken internationally to evaluate the impact of using DT and problem list in cancer patients. Studies concluded:The DT and problem list was a useful method to screen, triage, prioritize patient interventions(21),and improve patient satisfaction(22). It appeared to be a good instrument for routine screening, ruling out elevated distress(23),and identifying problems that warrant intervention(24).It provides a quick and easy screening tool to alert the healthcare team to clinically relevant alterations in patients' QOL(25). More than 50% of clinicians believed that the screening program helped with communication(26) , and it was appreciated by many patients(24). The tool was less utilized by inpatients, who had more opportunity to raise their concerns during more regular interaction with nursing staff, However, in both inpatient and outpatient settings, the tool was seen to provide an opportunity for patients to disclose problems that they may have been reluctant to verbalize(27).The use of routine distress screening by inpatient cancer services can significantly improve their capacity to offer psychosocial care(28). Future implementation and standardization of use of the DT as part of routine care will be recommended(29)
Despite its screening efficacy, the DT and PL have not been implemented in Saudi oncology clinics. there is currently no study that evaluate the impact of using DT and problem list in Saudi oncology clinics.
In this study, we are aiming to investigate if the implementation of DT and problem list will improve cancer patients’ outcomes including QOL and satisfaction in KKUH. The second aim of the study is to explore whether certain socio-demographic and medical factors are associated with distress.
1. Holland JC, Bultz BD. The NCCN Guideline for Distress Management’: A Case for Making Distress the Sixth Vital Sign. J Natl Compr Cancer Netw. 2007;5(1):3’7.
2. Fallowfield L, Ratcliffe D, Jenkins V, Saul J. Psychiatric morbidity and its recognition by doctors in patients with cancer. Br J Cancer. 2001;84:1011’5.
3. Johns T, Uni H, Johns T, Uni H. THE PREVALENCE OF PSYCHOLOGICAL DISTRESS BY CANCER SITE. Psychooncology. 2001;10:19’28.
4. Interventions S, Vitek L, Rosenzweig MQ, Stollings S. Distress in Patients With Cancer’: Definition, Assessment, and Suggested Interventions. Clin J Oncol Nurs. 2007;11(3):413’8.
5. Hiroki SC”, Paik I”N. Health-related quality of life in breast cancer’: A cross-cultural survey of German , Japanese , and South Korean patients. Breast Cancer Res Treat. 2006;99:341’50.
6. Cankurtaran ES, Soygu H. Screening for psychological distress in Turkish cancer patients. Psychooncology. 2007;16(August 2006):304’11.
7. Dimatteo MR, Lepper HS, Croghan TW. Depression Is a Risk Factor for Noncompliance With Medical Treatment. ARCH INTERN MED. 200AD;160:2101’7.
8. Von Essen L, Larsson G, Oberg K SP. ‘ Satisfaction with care ‘: associations with health-related quality of life and psychosocial function among Swedish patients with endocrine gastrointestinal tumours. Eur J Cancer Care (Engl). 2002;11(Fitzpatrick 1993):91’9.
9. Hamer M, Chida Y, Molloy GJ. Psychological distress and cancer mortality ‘. J Psychosom Res [Internet]. Elsevier Inc.; 2009;66(3):255’8. Available from: http://dx.doi.org/10.1016/j.jpsychores.2008.11.002
10. Chochinov HM, Wilson KG, Enns M MN. Desire for death in the terminally ill. Am J Psychiatry. 1995;152:1185’1191.
11. S”llner W, DeVries A, Steixner E, Lukas P, Sprinzl G, Rumpold G MS. How successful are oncologists in identifying patient distress, perceived social support, and need for psychosocial counselling? Br J Cancer. 2001;84:179’185.
12. Fallowfield L, Ratcliffe D, Jenkins V SJ. Psychiatric morbidity and its recognition by doctors in patients with cancer. Br J Cancer. 2001;84:1011’1015.
13. Gil F, Tomamichel M. Use of distress and depression thermometers to measure psychosocial morbidity among southern European cancer patients. Support Care Cancer. 2005;13:600’6.
14. Zigmond AS SR. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67:361’70.
15. Zabora J, Brintzenhofeszoc K, Jacobsen P, Curbow B, Piantadosi S, Hooker C, Owens A DL. A new psychosocial screening instrument for use with cancer patients. Psychosomatics. 2001;42:241’6.
16. Morasso G, Costantini M, Baracco G, Borreani C CM. Assessing psychological distress in cancer patients: validation of a self-administered questionnaire. Oncology. 1996;53:295’302.
17. Bulli F, Miccinesi G, Maruelli A, Katz M, Paci E. The measure of psychological distress in cancer patients: The use of distress thermometer in the oncological rehabilitation center of florence. Support Care Cancer. 2009;17(7):771’9.
18. Network NCC. ‘Distress management. Clinical practice guidelines.’ J Natl Compr Cancer Netw. 2003;1:344’374.
19. Roth AJ, Kornblith AB, Batel-Copel L, Peabody E, Scher HI, Holland JC. Rapid screening for psychologic distress in men with prostate carcinoma: A pilot study. Cancer. 1998;82(10):1904’8.
20. Donovan KA, Grassi L, Mcginty HL, Jacobsen PB. Validation of the Distress Thermometer worldwide’: state of the science. Wiley Online Libr. 2014;250(November 2013):241’50.
21. Dabrowski M, Boucher K, Ward JH, Lovell MM, Sandre A, Bloch J, et al. Clinical Experience with the NCCN Distress Thermometer in Breast Cancer Patients. J Natl Compr Cancer Netw |. 2007;5(1):104’11.
22. Change P, Guideline T. Distress Assessment’:Practice Change Through Guideline Implementation. Clin J Oncol Nurs. 2007;11(6):817’22.
23. Tuinman MA, Gazendam-Donofrio SM, Hoekstra-Weebers JE. Screening and referral for psychosocial distress in oncologic practice: Use of the distress thermometer. Am Cancer Soc. 2008;113(4):870’8.
24. Shim E, Shin Y, Jeon HJ, Hahm B. Distress and its correlates in Korean cancer patients’: pilot use of the distress thermometer and the problem list. J Psycho-oncology. 2008;17(October 2007):548’55.
25. Anderson B, Schapmire TJ, Keeney CE, Stacy M, Studts JL, Hermann CP, et al. Use of the Distress Thermometer to discern clinically relevant quality of life differences in women with breast cancer Stable URL’: http://www.jstor.org/stable/41411717 Use of the Distress Thermometer to discern clinically relevant quality of life differe. Qual Life Res. 2016;21:215’23.
26. Mitchell AJ, Lord K, Slattery J, Dcr T, Grainger L, Symonds P. How Feasible Is Implementation of Distress Screening by Cancer Clinicians in Routine Clinical Care’? Am Cancer Soc. 2012;118:6260’9.
27. O’Donnell E. The distress thermometer: a rapid and effective tool for the oncology social worker. Int J Health Care Qual Assur. 2013;26(4):353’9.
28. Lee SJ, Katona LJ, Bono SE De, Lewis KL, Medical T. Routine screening for psychological distress on an Australian inpatient haematology and oncology ward: impact on use of psychosocial services. Med J Aust. 2010;193(5):74’8.
29. Amstel FKP Van, Prins JB, Graaf WTA Van Der, Peters MEWJ, Ottevanger PB. The effectiveness of a nurse-led intervention with the distress thermometer for patients treated with curative intent for breast cancer’: design of a randomized controlled trial. BMC Cancer [Internet]. BMC Cancer; 2016;16:1’9. Available from: http://dx.doi.org/10.1186/s12885-016-2565-x
rationale:
we conducted this research because the distress thermometer screening program is not applied in saudi arabia hospital settings, the need of cancer patient to such a tool to help them to address their problems and not to forget to mention them to the doctor and it will help the physician as well in the patient management.
Research methodology
Methodology 1:
The research will be conducted at King Khalid university hospital (KKUH) at Riyadh, the oncology outpatient clinics. It is a cross-sectional prospective experimental study using the control group design (control group and the research group) the eligibility criteria are: 1- adult's cancer patient's ’18, excluding patients who have comorbidities with Alzheimer's or dementia. 2- Ability to read and communicate in Arabic (are there any specific excluded types of cancer?) 3- diagnosed during the last 12 months coming for external radiotherapy for ‘ 2 weeks or chemotherapy for ‘ 2 cycles.
The nurses at the oncology clinics will approach patients to confirm their eligibility and the informed consents will be signed by the patients if they want to participate in the study individulay. The distress thermometer and the problems list (DT & PL) will be given to the patients with the ( QUESTIONNAIRE that measures the variables that we have listed in our research title – the baseline questionnaire) th distress thermometer is able to identify the distress that is clinically significant on a scale from 0-10 the significant distress is considered from 4 and above. physical,family ,emotional ,spiritual and the needs that might cause the distress.
The control group ( cancer patients will just be given the baseline questionnaire), after 3 months ( which is the duration of the data collection phase) the control group will be given the the baseline questionnaire for the second time. the results for both the control and the research groups will be analyzed by (THE SPSS program). the data will be analyzed to find out:
number of cases referred to psychiatry? significant statistically?
the potential solutions.
referral to charity organizations and social services.
Methodology 2:
The research will be conducted at King Khalid university hospital (KKUH) at Riyadh, the oncology outpatient clinics. It is a before and after prospective experimental study using the(the quota sampling or ‘..) the eligibility criteria are: 1- adult's cancer patient's ’18, excluding patients who have comorbidities with Alzheimer's or dementia. 2- Ability to read to read and communicate in Arabic (are there any specific excluded types of cancer?) 3- diagnosed during the last 12 months coming for external radiotherapy for ‘ 2 weeks or chemotherapy for ‘ 2 cycles.
The nurses at the oncology clinics will approach patients to confirm their eligibility and the informed consents will be signed by the patients if they want to participate in the study individulay. The distress thermometer and the problems list (DT & PL) will be given to the patients with the ( QUESTIONNAIRE that measures the variables that we have listed in our research title – the baseline questionnaire) th distress thermometer is able to identify the distress that is clinically significant on a scale from 0-10 the significant distress is considered from 4 and above. physical,family ,emotional ,spiritual and the needs that might cause the distress.
Recruitment :
the patients will be recruited according of their file numbers( that have been taken from the first time) after a period of time around three months. them the ( questionnaire or the interview will be conducted with them for the second time to measure the variables that have been stated in the research title)
number of cases referred to psychiatry? significant statistically?
the potential solutions.
referral to charity organizations and social services.
”
References
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