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

Haejin Kim, Myungsun Yi
Korean Journal of Adult Nursing 2013;25(1):53-61.
Published online: February 18, 2013

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: September 18, 2012   • Accepted: February 19, 2013

© 2013 Korean Society of Adult Nursing

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.

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  • 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.
  • Key Words: Clinical trial; Neoplasms; Anxiety; Depression; Uncertainty
Table 1.
Anxiety, Depression and Uncertainty related to General Characteristics of the Subjects (N=106)
Characteristics Categories n (%) Anxiety Depression Uncertainty
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
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
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
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
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
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
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
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
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
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
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
r (p) r (p) r (p)
Anxiety 1    
Depression .70 (＜.001) 1  
Uncertainty .44 (＜.001) .60 (＜.001) 1
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    Anxiety, Depression and Uncertainty in Cancer Patients Participating in Clinical Trial of Anticancer Drugs
    Korean J Adult Nurs. 2013;25(1):53-61.   Published online February 28, 2013
    DOI: https://doi.org/10.7475/kjan.2013.25.1.53
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    Anxiety, Depression and Uncertainty in Cancer Patients Participating in Clinical Trial of Anticancer Drugs
    Korean J Adult Nurs. 2013;25(1):53-61.   Published online February 28, 2013
    DOI: https://doi.org/10.7475/kjan.2013.25.1.53
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    Anxiety, Depression and Uncertainty in Cancer Patients Participating in Clinical Trial of Anticancer Drugs
    Anxiety, Depression and Uncertainty in Cancer Patients Participating in Clinical Trial of Anticancer Drugs

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

    Characteristics Categories n (%) Anxiety Depression Uncertainty
    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
    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
    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
    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
    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  

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

    Variables Categories n (%) Anxiety Depression Uncertainty
    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
    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
    No 75 (70.8) 20.49±6.28 (.765) 30.75±9.76 (.718) 40.40±9.82 (.037)

    †Multiple response.

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

    Variables Categories n (%) Anxiety Depression Uncertainty
    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
    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  

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

    Variables Possible range Min~Max Total score Item score
    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.

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

    Variables Anxiety Depression U Uncertainty
    r (p) r (p) r (p)
    Anxiety 1    
    Depression .70 (＜.001) 1  
    Uncertainty .44 (＜.001) .60 (＜.001) 1
    Table 1. Anxiety, Depression and Uncertainty related to General Characteristics of the Subjects (N=106)

    Table 2. Anxiety, Depression and Uncertainty related to Medical Characteristics of the Subjects (N=106)

    Multiple response.

    Table 3. Anxiety, Depression and Uncertainty related to Clinical Trial Characteristics of the Subjects (N=106)

    Table 4. Levels of Anxiety, Depression and Uncertainty (N=106)

    Min=minimum; Max=maximum.

    Table 5. Correlations among Anxiety, Depression and Uncertainty (N=106)

    Table 1.

    Table 2.

    Table 3.

    Table 4.

    Table 5.

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