Anxiety, Depression and Uncertainty in Cancer Patients Participating in Clinical Trial of Anticancer Drugs

Haejin Kim; Myungsun Yi

doi:10.7475/KJAN.2013.25.1.53

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Kim and Yi: Anxiety, Depression and Uncertainty in Cancer Patients Participating in Clinical Trial of Anticancer Drugs

Original Research

Korean J Adult Nurs 2013;25(1):53-61.

Published online: 18 February 2013

DOI: https://doi.org/10.7475/KJAN.2013.25.1.53

Anxiety, Depression and Uncertainty in Cancer Patients Participating in Clinical Trial of Anticancer Drugs

Haejin Kim, Myungsun Yi

College of Nursing, Seoul National University, Seoul, Korea

Corresponding author: Kim, Haejin College of Nursing, Seoul National University, 103 Daehak-ro, Jongno-gu, Seoul 110-799, Korea Tel: +82-2-740-8839, Fax: +82-2-766-1852, E-mail: seastar4@snu.ac.kr

Received 18 September 201214 February 2013 Accepted 19 February 2013

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose

The purpose of the study was to identify the levels of anxiety, depression and uncertainty of patients who participated in the clinical trials for anticancer drug, and to identify correlations among these variables.

Methods

Cross-sectional survey used the Symptom Check List-90-Revision and the Mishel Uncertainty in Illness Scale from 106 subjects in 2011. The data were analyzed using descriptive statistics, t-test, ANOVA, Pearson correlation coefficients.

Results

The mean score of anxiety was 2.06, that of depression 2.35, and that of uncertainty 2.61. Anxiety and depression (r=.70), anxiety and uncertainty (r=.44), depression and uncertainty (r=.60) were significantly correlated each other. The levels of anxiety, depression and uncertainty were different in various characteristics of the subjects, such as education, recurrence, and economic burden.

Conclusion

The results of the study indicate that when implementing psychosocial interventions for cancer patients who participate in clinical trial, factors such as education, economic burden, and recurrence should be integrated into the intervention. Further studies applying theoretical model would be helpful to identify directional relationships among the variables that are important in psychosocial well-being of cancer patients undergoing clinical trial.

Keywords: Clinical trial, Neoplasms, Anxiety, Depression, Uncertainty

REFERENCES

Ahn H. J.., Tae Y. S.., Han Y. I.2007. The relationship between spiritual health and uncertainty in cancer patients having chemotherapy. Journal of Korean Oncology Nursing. 7(2):107–118.

Cho O. H.2000. Uncertainty, anxiety and coping with mastectomy for breast cancer. Journal of Korean Academy of Nursing. 30(4):1006–1017.

Chong S. O.., Chang S. B.., Lee W. H.., Kim J. H.2007. Relationship between spiritual health and depression of patients with hematologic malignancy. Journal of Korean Oncology Nursing. 7(1):56–67.

Ellis P. M.2000. Attitudes towards and participation in randomised clinical trials in oncology: A review of the literature. Annals of Oncology. 11:939–945.

Emergency Care Research Institute. 2002. Patients reasons for participation in clinical trials and effect of trial participation on patient outcomes. ECRI Health Technology Assessment Information Service. 74:1–38.

Gil K. M.., Mishel M. H.., Belyea M.., Germino B.., Porter L. S.., LaNey I. C., et al. 2004. Triggers of uncertainty about recurrence and long-term treatment side effects in older African American and Caucasian breast cancer survivors. Oncology Nursing Forum. 31(3):633–639.

Greer S.2002. Psychological intervention: The gap between research and practice. Acta Oncologica. 41(3):238–43.

Hong M. S.., Cho M. J.2010. The effects of music therapy on pain, depression and anxiety in terminal cancer patients. Journal of Korean Oncology Nursing. 10(1):112–118.

Jung J. O.2010, May 27. Anticancer drug development trials with lively bands has increased significantly. The Korea Economic Daily. 22.

Kang H. S.., Kim W. O.., Jeong I. S.., Baik J. M.2004. The working conditions and clinical trial practice of research nurses. Clinical Nursing Research. 9(2):42–55.

Kim H. Y.2006. Experience of patients with cancer participating in a clinical trial for the development of a new drug. Journal of Korean Oncology Nursing. 6(2):121–132.

Kim K. I.., Kim J. H.., Won H. T.1989. Korean manual of symptom ckecklist-90-revision. Seoul: ChungAng Aptitude Publishing Company.

Kim M. Y.2009. Transition of symptoms and quality of life in cancer patients on chemotherapy. Journal of Korean Academy of Nursing. 39(3):433–445. http://dx.doi.org/10.4040/jkan.2009.39.3.433.

Kim Y. J.2008. A study on cancer patients' and their family members' depression and suicidal ideation. Unpublished master's thesis, Hanyang University, Seoul.

Lee J. Y.., Choi S. M.2007. Quality of life in gynecological cancer patients during chemotherapy. Korean Journal of Women Health Nursing. 13(4):290–298.

Lee M. S.., Kim J. H.., Park E. Y.., Kim J. N.., Yu E. S.2010. Focus group study on psychosocial distress of cancer patients. Journal of Korean Academy of Adult Nursing. 22(1):19–30.

Lee P. S.., Sohn J. N.., Lee Y. M.., Park E. Y.., Park J. S.2005. A correlational study among perceived stress, anger expression, and depression in cancer patients. Journal of Korean Academy of Nursing. 35(1):195–205.

Lee S. H.., Choe B. I.., Kim C. M.., Kim K. S.2009. A survey on perception of clinical trial of pharmaceuticals and informed consent in Korea. Journal of Korean Society for Clinical Pharmacology and Therapeutics. 17(1):72–92.

Lev E. L.., Eller L. S.., Gejerman G.., Kolassa J.., Colella J.., Pezzino J., et al. 2009. Quality of life of men treated for localized prostate cancer: Outcomes at 6 and 12 months. Support Care Cancer. 17:509–517. http://dx.doi.org/10.1007/s00520-008-0493-2.

Mills E. J.., Seely D.., Rachlis B.., Griffith L.., Wu P.., Wilson K., et al. 2006. Barriers to participation in clinical trials of cancer: A meta-analysis and systematic review of patient- reported factors. The Lancet Oncology. 7(2):141–148.

Mishel M. H.1988. Perceived uncertainty and stress in illness. Research in Nursing & Health. 7:163–171.

Paik S. S.2010. Affecting factors on satification of clinical trial subjects. Unpublished master's thesis, Inje University, Busan.

Park B. W.., Hwang S. Y.2009. Depression and coping in breast cancer patients. Journal of Breast Cancer. 12(3):199–209. http://dx.doi.org/10.4048/jbc.2009.12.3.199.

Park J. H.., Jun E. Y.., Kang M. Y.., Joung Y. S.., Kim G. S.2009. Symptom experience and quality of life in breast cancer survivors. Journal of Korean Academy of Nursing. 39(5):613–621. http://dx.doi.org/10.4040/jkan.2009.39.5.613.

Park Y. M.2005. A structural model for quality of life in breast cancer patients. Unpublished doctoral dissertation, Kyung Hee University, Seoul.

Platonov P.., Varshavsky S.2002. Why do patients participate in trials? Good Clinical Practice Journal. 9(11):11–14.

Simonelli L. E.., Fowler J.., Maxwell G. L.., Andersen B. L.2008. Physical sequelae and depressive symptoms in gynecologic cancer survivors: Meaning in life as a mediator. Annals of Behavioral Medicine. 35(3):275–284. http://dx.doi.org/10.1007/s12160-008-9029-8.

Somerset W.., Stout S. C.., Miller A. H.., Musselman D.2004. Breast cancer and depression. Oncology. 18(8):1021.

Strong V.., Waters R.., Hibberd C.., McHugh G.., Wall L.., Walker J., et al. 2008. Management of depression for people with cancer (SMaRT oncology 1): A randomised trial. The Lancet. 372:40–48.

Suh Y. O.2007. Predictors of quality of life in women with breast cancer. Journal of Korean Academy of Nursing. 37(4):459–466.

Table 1.

Anxiety, Depression and Uncertainty related to General Characteristics of the Subjects (N=106)

Characteristics	Categories	n (%)	Anxiety		Depression		Uncertainty
Characteristics	Categories	n (%)	M±SD	t or F (p)	M±SD	t or F (p)	M±SD	t or F (p)
Gender	Male	50 (47.2)	19.82±6.27	-1.21	29.98±9.25	-1.04	41.04±11.11	-0.64
Gender	Female	56 (52.8)	21.32±6.44	(.228)	31.82±8.94	(.300)	42.29±8.95	(.524)
Age (year)	≤40	8 (7.5)	25.75±5.47	1.94	31.63±9.10	1.31	38.38±7.46	0.61
	41~50	26 (24.5)	19.58±5.57	(.110)	31.12±8.15	(.270)	41.38±11.65	(.656)
	51~60	39 (36.8)	19.67±6.17		29.05±8.82		40.90±9.65
	61~70	23 (21.7)	21.74±6.63		34.35±10.51		43.65±9.67
	≥71	10 (9.4)	20.30±7.93		29.60±8.28		43.80±9.84
Education	≤Middle school	14 (13.2)	23.43±6.28	4.23	32.50±9.51	2.78	47.57±9.72	7.05
	High school	48 (45.3)	21.58±5.99	(.017)	32.73±8.40	(.066)	43.46±8.70	(＜.001)
	≥College	44 (41.5)	18.66±6.37		28.52±9.33		37.91±10.17
Occupational status	Employed	30 (28.3)	19.07±6.24	-1.58	28.47±7.26	-1.79	39.27±9.87	-1.58
Occupational status	Unemployed	76 (71.7)	21.22±6.37	(.117)	31.93±9.58	(.077)	42.66±9.95	(.116)
Religion	Yes	69 (65.1)	21.51±6.20	2.00	31.42±8.83	0.72	41.92±10.11	0.30
Religion	No	37 (34.9)	18.95±6.44	(.051)	30.08±9.61	(.472)	41.30±9.91	(.764)
Marital status	Married	96 (90.6)	20.56±6.36	-0.25	30.79±8.95	-0.56	41.47±9.64	-0.73
Marital status	Unmarried	10 (9.4)	21.10±6.82	(.801)	32.50±10.76	(.574)	43.90±13.42	(.467)
Person paying for the medical expenses	Patient	48 (45.3)	19.65±6.01	0.71	30.38±9.12	0.71	39.88±10.22	2.71
	Spouse	42 (39.6)	21.24±6.25	(.550)	31.48±8.78	(.550)	41.48±8.84	(.049)
	Offspring	13 (12.3)	21.92±8.62		32.77±9.93		48.38±10.07
	Others	3 (2.8)	21.67±8.62		25.00±11.14		45.00±14.00
Economic burden	Mild	26 (24.5)	20.00±6.21	2.10	27.15±8.06	5.07	39.04±9.99	2.16
	Moderate	57 (53.8)	19.93±5.99	(.127)	31.00±9.20	(.008)	41.61±9.58	(.121)
	Severe	23 (21.7)	23.00±7.17		35.13±8.34		44.91±10.52
Primary caregiver	Spouse	79 (74.5)	20.49±6.27	0.25	30.57±9.03	0.85	41.46±9.32	0.09
	Children/relatives	15 (14.1)	20.27±8.02	(.778)	30.40±9.80	(.432)	42.33±14.31	(.914)
	None	12 (11.3)	21.83±5.04		34.17±8.69		42.50±8.68

Table 2.

Anxiety, Depression and Uncertainty related to Medical Characteristics of the Subjects (N=106)

Variables	Categories	n (%)	Anxiety		Depression		Uncertainty
Variables	Categories	n (%)	M±SD	t or F (p)	M±SD	t or F (p)	M±SD	t or F (p)
Type of diagnosis	Lung	24 (22.6)	20.63±6.81	1.57	29.13±9.77	1.81	41.38±11.33	0.99
	Breast	23 (21.7)	19.00±5.41	(.174)	29.96±8.22	(.117)	39.35±8.30	(.427)
	Stomach	18 (17.0)	20.06±5.74		30.78±9.56		41.22±13.02
	Liver	11 (10.4)	23.18±5.72		35.73±8.19		47.27±9.14
	Colon ‧ rectal	11 (10.4)	18.18±6.37		27.00±6.12		41.00±7.75
	Others	19 (17.9)	23.00±7.27		34.16±9.63		42.58±8.21
Duration since diagnosis (year)	＜1	25 (23.6)	19.92±5.51	2.44	29.36±8.29	1.74	40.96±10.75	0.16
	1~2	35 (33.0)	19.03±6.07	(.039)	28.66±8.20	4 (.133)	41.03±10.97	(.976)
	2~3	12 (11.3)	20.92±5.85		34.58±9.21		42.00±10.45
	3~4	11 (10.4)	19.73±6.51		30.64±9.86		43.00±7.79
	4~5	6 (5.7)	20.83±10.63		35.33±14.54		41.67±9.61
	5≤	17 (16.0)	25.18±5.34		34.12±8.24		43.12±8.96
Type of previous treatment^†	Chemotherapy	83 (78.3)	20.25±6.48	0.58	30.92±9.56	1.69	41.35±10.60	0.37
	Surgery	56 (52.8)	20.20±5.74	(.680)	29.95±8.02	(.155)	42.79±10.48	(.829)
	Radiotherapy	26 (24.5)	19.88±5.90		30.77±7.89		43.46±9.31
	Hormone therapy	4 (3.8)	22.25±5.62		33.25±4.86		44.50±14.25
	Others	3 (2.8)	25.00±5.57		43.00±3.61		39.67±6.51
Recurrence	Yes	47 (44.3)	22.17±6.78	2.29	33.85±10.18	8 2.94	42.96±10.39	1.16
Recurrence	No	59 (55.7)	19.37±5.79	(.024)	28.64±7.43	(.004)	40.69±9.65	(.249)
Other disease	Yes	31 (29.2)	20.90±6.71	0.30	31.45±7.35	0.36	44.84±9.87	2.11
Other disease	No	75 (70.8)	20.49±6.28	(.765)	30.75±9.76	(.718)	40.40±9.82	(.037)

^† Multiple response.

Table 3.

Anxiety, Depression and Uncertainty related to Clinical Trial Characteristics of the Subjects (N=106)

Variables	Categories	n (%)	Anxiety		Depression		Uncertainty
Variables	Categories	n (%)	M±SD	t or F (p)	M±SD	t or F (p)	M±SD	t or F (p)
Frequency of participation in other clinical trials	0	98 (92.5)	20.38±6.22	3.41	30.74±9.03	1.52	41.50±10.19	0.31
	1	6 (5.7)	26.33±6.35	(.037)	36.33±10.09	(.223)	44.83±8.38	(.733)
	2	2 (1.9)	15.00±7.07		25.00±1.41		42.00±1.41
Duration of participation (month)	＜12	77 (72.6)	19.92±6.61	1.37	30.81±9.53	1.45	42.71±10.46	1.39
	12~24	20 (18.9)	23.00±4.96	(.257)	30.60±7.11	(.233)	39.55±8.20	(.249)
	24~36	6 (5.7)	22.00±7.46		37.17±9.37		40.17±9.83
	≥36	3 (2.8)	19.67±4.04		24.67±2.31		33.00±0.00
Route of drug	Intravenous	55 (51.9)	20.62±5.34	0.01	30.80±8.39	-0.18	42.67±10.63	1.04
Route of drug	Oral	51 (48.1)	20.61±7.38	(.993)	31.12±9.87	(.858)	40.65±9.26	(.299)
How to know the clinical trial information	Medical staffs	102 (96.2)	20.51±6.19	2.50	30.65±17.65	1.88	41.76±10.07	0.22
	Acquaintance	1 (0.9)	12.00±0.00	(.087)	45.00±0.0	(.158)	45.00±10.02	(.800)
	Internet	3 (2.8)	27.00±9.85		36.67±9.02		38.33±10.00
Main decision maker	Patient	82 (77.4)	20.23±6.46	0.43	30.73±9.02	0.16	41.87±9.73	1.27
	Family	12 (11.3)	21.75±7.63	(.731)	30.75±9.12	(.925)	39.17±10.54	(.287)
	Acquaintance	5 (4.7)	22.20±6.61		32.60±11.44		37.40±8.62
	Medical staffs	7 (6.6)	22.00±1.63		32.71±9.98		47.14±12.39

Table 4.

Levels of Anxiety, Depression and Uncertainty (N=106)

Variables	Possible range	Min~Max	Total score	Item score
Variables	Possible range	Min~Max	M±SD	M±SD
Anxiety	10~50	10~38	20.61±6.38	2.06±0.64
Depression	13~65	13~53	30.95±9.09	2.35±0.70
Uncertainty	16~90	16~73	41.70±10.00	2.61±0.63

Min=minimum; Max=maximum.

Table 5.

Correlations among Anxiety, Depression and Uncertainty (N=106)

Variables	Anxiety	Depression U	Uncertainty
Variables	r (p)	r (p)	r (p)
Anxiety	1
Depression	.70 (＜.001)	1
Uncertainty	.44 (＜.001)	.60 (＜.001)	1

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