Evaluation of an evidence-based education package for men with prostate cancer on hormonal manipulation therapy

Evaluation of an evidence-based education package for men with prostate cancer on hormonal manipulation therapy

Patient Education and Counseling 55 (2004) 55–61 Evaluation of an evidence-based education package for men with prostate cancer on hormonal manipulat...

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Patient Education and Counseling 55 (2004) 55–61

Evaluation of an evidence-based education package for men with prostate cancer on hormonal manipulation therapy Hazel Templeton a,∗ , Vivien Coates b a

School of Nursing, University of Ulster at Magee, Londonderry, Northern Ireland BT48 7JL, UK b University of Ulster at Coleraine, Coleraine, UK Received 1 April 2003; received in revised form 15 July 2003; accepted 28 July 2003

Abstract Prostate cancer has become a public health problem worldwide with considerable social and economic consequences. Many men have extraprostatic spread at diagnosis, and treatment usually involves hormonal manipulation therapy, which can challenge the stereotypical male image. It is often assumed that merely the provision of educational material for patients in an accessible form is sufficient to address informational needs. However, with the increasing emphasis on evidence-based practice, an essential element of the patient education process is evaluation of the impact of educational interventions. In this study, a randomised controlled trial was used to evaluate the effect of an evidence-based education package on the knowledge of disease and treatment, quality of life, coping and satisfaction of a sample (n = 55) of men with prostate cancer on hormonal manipulation therapy in the UK. The men were randomly assigned to experimental (n = 28) and control group (n = 27). Established instruments with satisfactory reliability and validity were used to measure the dependent variables. The independent variable, namely the education package, had been developed following the results of a previous study, which assessed the informational needs of this client group. This package consisted of an information booklet supplemented by the verbal teaching of a urology nurse. Results demonstrated that delivery of the education package had a significant effect on knowledge, quality of life and satisfaction with care, but not on coping. This study has contributed to the evidence-base for practice in urological nursing. This education package should become a routine, and not merely incidental aspect of care for this client group. © 2003 Elsevier Ireland Ltd. All rights reserved. Keywords: Hormonal manipulation therapy; Patient education; Prostate cancer; Randomised controlled trial

1. Introduction Prostate cancer is an important public health problem with considerable social and economic consequences [1]. It is reported that over 20,000 men are diagnosed with prostate cancer in the UK annually, 9500 of which presently result in death [2]. It has recently overtaken lung cancer as the most common cancer affecting men in the UK [2]. This high incidence is common in all western countries. Prostate cancer has a protracted natural history of progression and many men have extraprostatic spread at diagnosis. For these men, the mainstay of treatment usually involves hormonal manipulation therapy (HMT). This treatment is also known as cytoreduction and is a form of palliative treatment for incurable malignancy [3]. Many adverse side effects of HMT exist and include breast tenderness, gynaecomastia, impotence, hot flushes and decreased libido [4]. These side effects are ∗ Corresponding author. Tel.: +44-28-71375400; fax: +44-28-71375493. E-mail address: [email protected] (H. Templeton).

not only extremely distressing, but they may also challenge the stereotypical image of men and diminish self-esteem [4]. When diagnosed with prostate cancer, patients face numerous threatening events in the course of their illness that can provoke emotional responses, such as loneliness, grief and despair [5]. This can create an array of needs that individuals often find difficult to cope with and resolve. Perhaps the greatest terror is the fear of the unknown and the associated uncertainty. Evidently, cancer produces intense demands for information and assurance, which is viewed as an essential form of support [6]. Research has demonstrated that individuals with varying cancer diagnoses have many informational needs [7–9]. Needs assessments must be undertaken and used to develop educational material that is accurate, relevant and perceived as important to the individual. One often assumes that the provision of educational material for patients in an accessible form will influence practice [10]. However, with the increasing emphasis on evidence-based practice, such assumptions are unacceptable. An essential element of the patient education process is evaluation of the impact of education. As

0738-3991/$ – see front matter © 2003 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.pec.2003.07.005


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patient education plays a key role in quality patient care, its’ evaluation must conform to the rigour essential to any therapeutic undertaking [11]. An interesting editorial describes education that has been evaluated and found to be effective as ‘evidence-based education’ ([12], p. 1) and adds that there is a lack of evidence about effective evidence-based education. Prior to this study, a knowledge and informational needs assessment was undertaken with a sample of men (n = 90) with prostate cancer on HMT [13]. Results indicated that these men had knowledge deficits and many informational needs regarding their disease and treatment that were not being addressed in the current approach to care. Informational needs were assessed using an adapted version of the Toronto Informational Needs Questionnaire [8]. This instrument was adapted for use with men with prostate cancer on HMT [14]. The subscales of informational need assessed were disease, investigative tests, physical, psychosocial and treatment needs. These results, coupled with results of an extensive literature review regarding patient education issues and relevant theoretical information relating to the Andragogical Theory of Adult Learning [15] were utilised to develop an evidence-based education package. This education package took the form of an information booklet that was used as an adjunct to the verbal teaching of an urology nurse. Many theoretical and contextual issues were considered in the development of the information booklet to ensure that it was suitable for the client group, including the readability level, format and use of diagrams (Table 1). The development process of the education package, with full justification for the decisions made, has been fully outlined by the researcher [16]. It was the aim of this study to evaluate the effect of this education package on identified patient outcomes.

2. Methodology The aim of this study was to evaluate the effect of an evidence-based education package on the knowledge of disease and treatment, quality of life (QOL), coping and satisfaction with care of a sample of men with prostate cancer on HMT. 2.1. Research design With increasing emphasis on evidence-based practice, the most valid evidence comes from well-designed randomised controlled trials (RCT). It has been noted that: ‘. . . new packages of information should be devised only within the context of a RCT’ ([17], p. 12). 2.2. Sample Participants were recruited from two urology centres in Northern Ireland. Inclusion criteria were men with a known diagnosis of prostate cancer, who commenced HMT within the year 2000. Confused or terminally ill patients and patients who were unaware of their diagnosis were excluded from the sampling process. Sixty-six men were identified who fulfilled these criteria. Ethical approval was obtained from the university and hospital ethics committees. The men were initially contacted by letter from their consultant urologist, explaining the nature of the project. They were given the right to refuse to participate or to withdraw from the study at any stage and confidentiality was assured. The men were asked to reply using an enclosed form if they did not wish to participate in the study. Those who did not reply were followed up by

Table 1 Theoretical and contextual issues included in education booklet Feature A5 in size Table of contents Black text on white matt paper, with some colour extracts and adequate spacing between sections of text Headings used Font 12 text Diagrams to aid understanding of the location of the prostate gland and to explain grading system of prostate cancer. Diagrams also secure interest and attention of the target audience. All diagrams be placed near the relevant text Use of the active voice Personalised text by the use of such phrases as ‘you’ and spaces for naming the individual’s treatment and name of urologist Flesch reading ease score of 60–70 Spare pages to note any questions that may arise while reading the information booklet Education package presented to the patient on an individual basis Presentation of information in a structured manner Based on Andragogical Theory of adult learning Detailed sections included on: What is prostate cancer? Hormonal treatment Possible side effects of hormonal treatment Going for tests Useful contact addresses What happens now?

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a telephone call to confirm that they wished to participate, further explain the study and address any concerns. 2.3. Measures An instrument previously developed by the researcher was used to measure knowledge of prostate cancer and HMT [13,14]. Content validity was established by a panel of urological experts. QOL was assessed using the Functional Assessment of Cancer Therapy-Prostate cancer version (FACT-P) [18]. This instrument measures physical, social/family, emotional and functional well-being and prostate cancer specific issues and has been successfully used in other research with this client group. This instrument has content validity and satisfactory internal consistency, demonstrated by a Cronbach’s α ranging from 0.87 to 0.89. [18,19]. This instrument is also written at sixth grade reading level and only takes 8–10 min to complete, making it user friendly and suitable for administration to a wide range of socioeconomic populations [19]. Coping was measured using the Jalowiec Coping Scale (JCS-40), which assesses affective and problem-oriented coping strategies [20]. This instrument also exhibits satisfactory reliability and validity. Internal consistency reliability of 0.75–0.86 has been established for this scale and construct validity has been confirmed using factor analysis [20,21]. The eight-item version of the Client Satisfaction Questionnaire (CSQ-8), a generically written measure of global client satisfaction, was deemed most appropriate to measure satisfaction [22]. It is a simple self-report questionnaire with satisfactory reliability, demonstrated by Cronbach’s α = 0.93 [23]. The demographic details collected were regarding age, martial status and social class. 2.4. Data collection Fifty-eight men participated in the pre-test. Of the other eight men, who were invited to participate, seven men refused and one man had recently died. Simple random sampling using random numbers tables was used to assign these men to either control group (CG) (n = 29) or experimental group (EG) (n = 29). The pre-test took the format of a structured interview conducted in the participants’ own homes, as this was the preference of the participants. This technique has been recommended for use with men with prostate cancer [24]. The men were reassured about the confidential nature of the information. They were told that one month later, they would be receiving a second questionnaire by post. It was believed that interviewer presence at post-test might have been construed as introducing bias into the study. The education package was delivered to the EG following completion of the pre-test questionnaire. Key points that arose from the Audit Commission report relating to the provision of verbal information to patients were considered and integrated into the process of delivering the information to the patient [25]. This included the allocation of scheduled


time for teaching, and the importance of introductions to include information relating to the position of the nurse and remit of the teaching [25]. As it is essential that a consistent message is conveyed between health care professionals [26], the researcher read through the information booklet with each participant. After completion of each section, the participant was asked if there was any information that they would like clarified and the main points were summarised. This approach helps the listener to assimilate and retain the information provided. Other practical tips for promoting patient understanding of information were integrated into the delivery of the education package [27]. These included allowing the patient to decide the speed of the delivery of the intervention, respecting silence, repeating information as required and the use of simple language with simple explanations. The Audit Commission concluded that patients must be made aware of the means by which they could obtain further information [25]. Therefore, the education package ended with such information. At post-test, all men were posted a second questionnaire and covering letter. They were given a contact telephone number should they require assistance. A total of 55 men replied (EG = 28; CG = 27), eliciting a response rate of 85%. Data was analysed using SPSS version 9.0 [28]. Descriptive and inferential statistics were calculated for each of the dependent variables.

3. Results 3.1. Demographic details Although there was wide variation in the age of the participants, the greatest percentage of men (41.8%) were aged 71–80 years. Social class was assessed using the standard occupational classification [29]. The highest percentage belonged to Social Class II Non-manual. Thirty-eight (69.1%) of the total sample were married men. Demographic details of the CG and EG are outlined in Table 2. On analysis using the independent sample t-test, it was established that there were no significant difference between the groups regarding age group (t = 1.281; d.f. = 53; P = 0.206), marital status (t = 1.103; d.f. = 53; P = 0.275) or social class (t = −0.292; d.f. = 53; P = 0.772). Therefore, it was concluded that the EG and CG were matched regarding these variables. 3.2. Knowledge of disease A potential score of 14 could be obtained in the questionnaire assessing knowledge of disease. Both groups had a poor knowledge of prostate cancer at pre-test demonstrated by a mean score of 3.19 (S.D. = 1.96) in the CG and 4.04 (S.D. = 1.88) in the EG. No significance difference existed between the groups regarding their pre-test knowledge of


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Table 2 Demographic details of participants in study Demographic details


Age group

Social class

Marital status

Table 4 Statistical analysis of FACT-P between pre- and post-test

Experimental group, % (n = 28)

Control group, % (n = 27)


51–60 61–70 71–80 80+

17.9 32.1 35.7 14.3

(5) (9) (10) (4)

7.4 25.9 48.1 18.5

(2) (7) (13) (5)

I Non-manual II Non-manual III Non-manual III Manual IV Manual V Manual

3.6 46.4 10.7 21.4 14.3 3.6

(1) (13) (3) (6) (4) (1)

7.4 44.4 14.8 22.2 0 11.1

(2) (12) (4) (6)

Physical well-being Emotional well-being Social & family well-being Functional well-being Prostate cancer specific concerns FACT-G FACT-P

Married Single Divorced Widowed Separated

75 (21) 10.7 (3) 0 10.7 (3) 3.6 (1)


63 (17) 11.1 (3) 0 18.5 (5) 7.4 (2)

disease (t = −1.644; d.f. = 53; P = 0.106). Knowledge of disease was considerably different at post-test. The mean knowledge of disease score at post-test was 4.04 (S.D. = 3.30) in the CG and 11.11 (S.D. = 3.33) in the EG. Paired sample t-test demonstrated that there was a significant difference between the pre and post-test knowledge of disease scores of the EG (t = −12.769; d.f. = 27; P < 0.001), while no significant difference existed between these scores in the CG (t = −1.940; d.f. = 26; P = 0.063). 3.3. Knowledge of treatment Results regarding knowledge of treatment exhibited similar trends and are outlined in Table 3. A potential total score of 10 was calculated for knowledge of treatment. Paired sample t-tests indicated that a significant difference existed between the pre- and post-test knowledge of treatment scores for the EG (t = −11.728; d.f. = 27; P < 0.001) but not in the CG (t = −0.657; d.f. = 26; P = 0.517).

Pre-test Post-test

Control group (d.f. = 26)







28 28

2.89 7.46

1.37 2.33

27 27

2.41 2.67

1.58 2.27

0.667 0.248 0.866 0.261 0.01 0.532 0.225

It was found that both the EG and CG used problemoriented coping mechanisms more often than affective coping mechanisms at pre and post-test. On further analysis, it was found that there was no difference in the coping mechanisms utilised by the CG (t = −1.35; d.f. = 26; P = 0.188) or the EG (t = −1.585; d.f. = 27; P = 0.125) between preand post-test. The most commonly used coping mechanisms of the EG and CG are outlined in Table 5.

Table 5 Most commonly utilised coping mechanisms of total sample at pre-test

4 17 21 19 18


Experimental group (d.f. = 27)

0.002 <0.001 0.001 <0.001 0.023 <0.001 <0.001

3.5. Coping

39 Table 3 Knowledge of treatment scores

Control group (d.f. = 26)

Cancer Therapy-Prostate cancer version (FACT-P). Statistical testing revealed that, while no statistical difference existed in any of these subscales between the EG and CG at pre-test, a significant difference existed in all subscales of the FACT-P in the EG between pre- and post-test. No significant difference existed in the majority of the subscales in the CG apart from the PCS, which declined at post-test. These results are illustrated in Table 4. The internal consistency reliability of the FACT-P was retested in this study and Cronbach’s α = 0.943 was obtained and considered satisfactory.

3.4. Quality of life The subscales of QOL assessed by the FACT-P were physical, social/family functional and emotional well-being and prostate cancer specific (PCS) concerns. A score was then calculated for the General Functional Assessment of Cancer Therapy (FACT-G) and the Functional Assessment of

P Experimental group (d.f. = 27)

10 25 33




Hope that things get better (A) Accept the situation as it is (P) Pray; put your trust in God (P) Try to maintain some control over the situation (P) Try to look at the problem objectively and sell all sides (P) Don’t worry about it, everything will probably work out fine (A) Try to draw on past experience to help you handle the situation (P) Try to put the problem out of your mind and think of something else (A) Actively try to change the situation (P) Try out different ways of solving the problem to see which works best (P)

3.67 3.58 3.47 3.29

0.86 1.12 1.26 1.10









2.89 2.82

1.20 1.16

A, affective coping; P, problem-oriented coping.

H. Templeton, V. Coates / Patient Education and Counseling 55 (2004) 55–61 Table 6 Satisfaction with care scores

Pre-test Post-test

Experimental group (d.f. = 27)

Control group (d.f. = 26)







28 28

23.93 28.07

4.94 4.57

27 27

26.93 27.78

4.1 5.08

3.6. Satisfaction with care A cumulative score of 32 is possible using the CSQ-8 to assess satisfaction with care. Table 6 illustrates the scores obtained by the EG and CG at pre- and post-test. There was a significant difference between the groups at pre-test (t = 2.442; d.f. = 53; P = 0.018), with the CG more satisfied with their care. The paired sample t-test revealed that no significant difference existed between the pre- and post-test CSQ-8 scores of the CG (t = −1.925; d.f. = 26; P = 0.065) but satisfaction with care was significantly improved in the EG between pre- and post-test (t = −6.476; d.f. = 27; P < 0.001). No significant difference existed between the age groups, marital status and social class of the CG or EG regarding satisfaction with their care.

4. Discussion and conclusion The results of this study make a significant and unique contribution to the body of knowledge relating to the education of men with prostate cancer on HMT. The education of this client group had previously been neglected, indicated by a distinct absence of research [30]. Patient education of elderly patients with cancer, such as these men, is an educational priority. As increasing numbers of men are diagnosed with prostate cancer, health care professionals are challenged to develop educational programmes aimed at meeting the needs of these men. Such programmes must be adequately evaluated and such evaluations must conform to the rigour essential to any therapeutic undertaking. The education package evaluated in this study was developed from the results of an informational needs assessment previously conducted with this client group [13], the results of an extensive literature review and sound theoretical underpinnings [15,16]. The content is therefore, considered to be evidence based. The results of this RCT demonstrated that this education package had a significant effect on knowledge of disease and treatment. It has been recognised that the knowledgeable patient with prostate cancer is better able to work through dilemmas associated with the disease and move forward with their lives and may experience less emotional distress [31]. Knowledge is a source of personal control for cancer patients which helps them cope with the circumstances surrounding their illness. Concern for improving patients’ QOL has, in many contexts, become as important as the regard for extending quantity of life. It has been recognised that prostate cancer can


have a negative effect on QOL [32,33]. In this study, the FACT-P was successfully utilised to establish that education had a significant effect on all subscales of QOL as measured by the FACT-P. A significant difference was also noted in general QOL (FACT-G) and prostate cancer specific QOL (FACT-P). It is believed that education provides patients with a cognitive schemata that facilitates adaptation to stressful events by assisting the individual to understand, predict the course of and cope with disease and treatment-related problems more effectively, which has a positive effect on physical and functional factors that may affect QOL [32]. It has also long been documented that cognitions play a major role in emotional response and that well-informed patients report less emotional distress [34,35]. Knowledge may alleviate the helplessness and inadequacy associated with uncertainty, thus enhancing emotional well-being. The improvement in the social/family well-being of the EG at post-test may be attributed to the strengthening effect of education on relationships that cancer patients have with others [36]. Results of this study indicated domains where attempts could be made to improve the QOL of these men. QOL was significantly affected by lack of energy and sexual issues, echoing other research findings [33,37]. The nurse working with the individual with prostate cancer must be aware of the prevalence of such problems and implement appropriate interventions to help these men adapt accordingly. Patient satisfaction has become a ubiquitous concept in health care evaluation. The men involved in this study expressed a consistently high level of satisfaction with their care both at pre- and post-test, paralleling other studies [38,39]. These results may not truly reflect reality as patients, particularly the elderly are often more likely to express satisfaction with their care. Despite this, the education package had a significant positive effect on satisfaction with care. Although it was anticipated that more positive coping as a result of the education would result in an increased use of problem-oriented coping strategies by the EG, these men demonstrated stability in coping mechanisms over time. The use of problem-focused coping could illustrate that these men were already coping with their disease and treatment as such coping is associated with positive outcomes [40]. Knowledge of how specific individuals cope is an essential prerequisite when developing interventions to meet the patients’ needs. It has been suggested that patients who use affective oriented coping strategies should be offered group programmes whereas those, who use problem-oriented strategies require a cognitive-informative intervention [41]. This knowledge of how these men cope could be further used to develop individualised programmes tailored to individual coping strategies. 4.1. Limitations Stage of disease was not measured in this study. This factor may influence a patient’s response to education. As this


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study was not prospective, comparison cannot be made with the QOL, coping and satisfaction prior to treatment. Future research should assess these variables to obtain a more accurate representation of the precise effect of education. A 1-month lapse between pre- and post-test was quite short. A longer time lapse would have been useful to assess whether the education package had a significant effect in the long term. Researcher’s presence during the delivery of the education package, may have threatened internal validity. It is not known whether the teaching of the researcher or the information booklet caused the significant differences in the variables. This potential effect could have been eliminated by the presence of a third group, who received the information booklet only. Unfortunately due to the finite number of men in the province who met the eligibility criteria, this would have decreased the power of the study. It was believed that the randomisation process used minimised this effect.

[2] [3] [4] [5] [6] [7] [8]



4.2. Practice implications [11]

Results of this study provide clear direction for clinical practice. Informational needs assessment should be conducted with all men diagnosed with prostate cancer, who are to be commenced on HMT. The ensuing patient education should use the education package developed in this study as a foundation but be directly related to the individual informational needs identified. This will promote evidence-based practice for nurses working in urology. Such practice is inseparable from continuous quality improvement. In the present era, health care professionals have a moral, legal, ethical and professional obligation to engage in such practice [42]. Patient education of men with prostate cancer on HMT should become a routine, not incidental aspect of patient care. Such practice will help these men retain optimum control in their lives at a time when they may well feel powerless and helpless. It has the potential, not only to empower patients, but to humanise their journey through the process of diagnosis and treatment.

[12] [13]


[15] [16]




Acknowledgements This project was funded by the Mona Grey Research Scholarship, Astra Zeneca Pharmaceuticals and the Prostate Research Campaign, UK. The authors also acknowledge the invaluable assistance provided by Professor Scott Brown, University of Ulster. Many thanks are extended to the patients, who participated in this study and the experts in urology for their professional advice and guidance.


[21] [22]


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