Intervention Planning
Review of the literature
Systematic review and meta-analysis of depression and anxiety in prostate cancer
Aim:
An evidence-based approach activity to systematically review literature around depression and anxiety prevalence in patients with prostate cancer (published elsewhere)(4).
Methods:
Due to a lack of previous research about depression and anxiety in men specifically on the AS pathway this review included men on other PCa treatment pathways. After de-duplication, 1130 articles were screened for eligibility, and 27 full journal articles were included giving a total sample size of 4494 prostate cancer patients.
Results:
Anxiety and depression were highly prevalent, and levels varied throughout the course of the illness and according to treatment status. A pattern of depression and anxiety was identified showing rates were highest after diagnosis before treatment, (depression: 17.27% (95% CI 15.06% to 19.72%)), (anxiety: 27.04% (95% CI 24.26% to 30.01%)), lowered during treatment (depression: 14.70% (95% CI 11.92% to 17.99%)), (anxiety: 15.09% (95% CI 12.15% to 18.60%)), and then raised again when treatment was complete (depression: 18.44% (95% CI 15.18% to 22.22%)), (anxiety: 18.49% (95% CI 13.81% to 24.31%)).
Relevance to PROACTIVE planning:
Of the 27 articles included, only 4 involved AS patients(15-18). The upper depression and anxiety prevalence rates reported within these articles were high, 17% and 21% respectively, indicating the need for further research into the psychological impact of AS, and an investigation into the use of a support tool.
Cross-sectional survey study
Cross-sectional assessment of depression and anxiety prevalence in prostate cancer patients undergoing AS
Aim:
To further explore the issue of heightened anxiety and depression in men with PCa, and provide a broader picture specific to AS, the research team conducted a cross-sectional assessment aiming to explore depression and anxiety prevalence specifically in prostate cancer patients undergoing AS. The full study is published elsewhere(5).
Methods:
313 men being managed by AS for PCa across 7 UK urology centres were recruited. The primary outcome was the Hospital Anxiety and Depression Scale (HADS)(19). The survey collected demographic data (age, employment, relationship, ethnic and educational status), to allow for cross-tabulation with anxiety and depression scores.
Results:
Results from this survey indicated a clinical depression prevalence of 12.5%, and clinical anxiety prevalence of 23% measured by the HADS. The results show a more than doubled depression prevalence, and almost tripled anxiety prevalence in men on AS for prostate cancer compared to men of a similar age in the general population (6% and 8% respectively(20)). Divorce was the only demographic predictor of higher anxiety and depression(5), indicating the family environment may need further investigation also.
Implications for PROACTIVE:
With the combined results from the systematic review and cross-sectional assessment indicating elevated levels of anxiety and depression, the research team concluded the levels of distress in men on AS for PCa needs to be addressed.
Review of existing interventions in the field
To gain an insight into whether informational, psychological, emotional or cognitive interventions can positively impact men with prostate cancer, the research team conducted a narrative literature review of supportive psychological interventions within prostate cancer (published elsewhere)(21). Ideally this review would have focussed on AS patients, however, due to a paucity of interventions in this area, interventions for PCa not exclusive to AS were included. The interventions were categorised by delivery mode: delivered in a group-based environment, delivered over the phone, delivered over the internet or delivered by other means. Intervention components and intervention effectiveness were considered in tandem (listed below in Table 2) to enhance understanding of the components that may be effective in a new intervention. See Table 2 for a summary of the self-care interventions and the implications for PROACTIVE.
Table 2: Self-care psychological interventions targeting prostate cancer patients
Author(s)
|
Mode of delivery
|
Intervention description
|
Intervention components
|
Results / Effectiveness / points of interest
|
Implications for PROACTIVE
|
Parker et al (2009)(22)
|
Group based environment
|
Pre-surgical stress management programme for men undergoing radical prostatectomy
|
2 x 90 minute sessions that involved:
- Learning relaxation skills
- Guided imaginary rehearsals of surgery day
- Discussion about fears and implementation of coping strategies.
2x booster sessions: on the morning of surgery; and 48 hrs post surgery
|
Significantly less mood disturbance, cancer related worries and physical side effects than controls. Effects maintained at 12 months. 221 potential participants approached, 159 took part.
|
Level of uptake suggests PCa patients are willing to take part in self-care interventions to improve psychological wellbeing.
|
Penedo et al (2004 & 2006)(23, 24)
|
Group based environment
|
Cognitive behavioural stress management intervention with men who had received either radical prostatectomy or radiotherapy for PCa
|
10 week intervention with 2 hour weekly sessions involving:
- Implementing relaxation techniques
- Utilising techniques such as identifying distorted thoughts
- Goal setting
- Utilising social support.
|
Significant improvements in both general and PCa specific quality of life compared to controls.
|
In PCa patients relaxation interventions are both well received and clinically effective.
|
Carlson et al (2003 & 2007)(25, 26)
|
Group based environment
|
Standardised Mindfulness Based Stress Reduction (MBSR) course
|
8 weekly sessions incorporating:
- Relaxation
- Meditation
- Gently yoga
- Daily home practice
(Note: Recruits not exclusively PCa).
|
Significant improvements in sleep, stress, anxiety, mood and fatigue.
|
Results were not stratified by disease type, so hard to draw any strong implications for PROACTIVE, however, the study findings do support the notion of group-based support for cancer patients.
|
Templeton & Coates (2004)(27)
|
Group based environment
|
Educational intervention
|
Brief, group-based, nurse-led single session for men being treated with hormone therapy for PCa. Participants were provided with an information booklet.
|
Compared to controls, significant improvements in general and PCa specific quality of life, PCa knowledge and satisfaction with care.
|
Intervention effectiveness may not be dose related, and short interventions may be as effective as more time consuming programmes. Information provision is valued by PCa patients. The participants in this trial were receiving hormone treatment and those on AS may feel differently.
|
Berglund et al (2007)(28)
|
Group based environment
|
Psychosocial rehabilitation
|
7-week group based intervention. 3 arms; information arm, physical activity arm, combined arm, plus a control group.
- Information arm led by PCa nurse and participants received information about what PCa is, treatment options, side effects, and methods of dealing with urinary and erectile dysfunction.
- Physical activity arm led by physiotherapist and focussed on increasing daily exercise.
- Combined arm received both
|
No significant improvements in anxiety, depression or quality of life.
|
Unclear why the intervention was unsuccessful, perhaps information needs to be combined with relaxation/stress management techniques.
|
Lepore et al (2003)(29)
|
Group based environment
|
Educational intervention
|
3 groups, intervention, intervention plus discussion, control group. Intervention involved 6 1-hour weekly group sessions involving:
- Prostate cancer biology information
- Treatment options
- Managing side effects
- Diet and nutrition
- Stress, coping and relaxation.
|
Both intervention arms showed significant improvements in PCa knowledge and experienced less sexual dysfunction compared to the control group. No significant improvements in depression.
|
Depression baseline taken after treatment, low levels to start with so hard to draw conclusions for PROACTIVE from this.
|
Bailey et al (2004)(30)
|
Telephone
|
Intervention to manage uncertainty
|
This was designed for men on watchful waiting. 5 brief telephone consultations with a male PCa nurse, with week-long intervals. Telephone consultations around:
- Re-framing negative thoughts
- Managing uncertainty
- Accepting watchful waiting
|
Significant improvements in quality of life and uncertainty management compare to controls.
|
This study limited by high homogeneity in the sample, and watchful waiting patients may be different to AS patients.
|
Chambers et al (2013)(31)
|
Telephone
|
Psycho-educational intervention
|
5 brief telephone consultations with PCa patients around:
- Cognitive reframing
- PCa education
- Management of side effects
- Management of stress
- Developing problem solving skills
|
Significant improvements in mental health and cancer related distress in younger patients with higher levels of education and income, but not in the rest of the sample.
|
Heterogeneous sample compared to Bailey et al (2004), and large sample recruited from multiple centres. Indicates telephone support may not be effective for some groups of PCa patients.
|
Kazer et al (2011)(32)
|
Internet
|
Intervention to manage uncertainty
|
5 week online intervention named “Alive and Well” for men on AS. Components included:
- Cognitive reframing of negative thoughts
- PCa & AS information
- Lifestyle advice
- Tailored emails
|
Significant improvement in 8 of the 12 quality of life subscales measured at the end of the intervention.
|
An online-only intervention improve quality of life in men on AS.
|
Osei et al (2013)(33)
|
Internet
|
Intervention to improve quality of life
|
6 week online intervention for men radically treated for PCa involving:
- Online support forum
- PCa information
- Support managing side effects.
|
Significant improvements in quality of life, but not maintained at follow-up.
|
Support may need to be more long term to improve outcomes beyond the study timeframe.
|
Weber et al (2004)(34)
|
Other – dyadic support
|
Social support intervention
|
Post-radical prostatectomy patients paired with men who had the same surgery 5 years previously. Men in the intervention arm met with long term survivors once a week for 8 weeks.
|
Men in intervention arm reported significantly lower levels of depression and significantly higher levels of self-efficacy compared to controls. High attrition rate – all 8 sessions attended by every intervention arm participant.
|
Dyadic support well adhered to. Support from men who have had similar experiences can be effective in improving psychological outcomes.
|
Qualitative study with a sample of the target audience
Aim:
The research team carried out a qualitative study with the aim of gaining a more in-depth and specific understanding of the supportive care requirements of prostate cancer patients being managed with AS. The full study is published elsewhere(8), and an overview is presented below.
Methods:
20 men on active surveillance were recruited from the prostate cancer clinic at Southampton General Hospital. Semi-structured qualitative interviews were conducted and analysed inductively using thematic analysis.
Results:
Table 3 shows the key findings that emerged from the data. In summary, the men reported high levels of emotional distress, a lack of knowledge about their condition or how to self-manage it, and a desire for more information and support(8).
Table 3: Key findings from the qualitative study
Theme
|
Description
|
Quote
|
Emotional Distress
|
All of the men interviewed showed increased levels of emotional distress to varying degrees due to being on active surveillance.
|
“You are told that you have cancer but that it’s nothing to worry about and that all they are going to do is watch it to see how it grows. That just doesn’t make sense; if something can be done prior to it spreading, why isn’t it being done? It freaks you out.” (Interviewee 5, aged 72)
|
Lack of information and knowledge
|
Part of the reason for the increased levels of emotional distress seemed to be attributed to a lack of understanding and lack of information received about active surveillance.
|
“If they had said what active surveillance is then perhaps I might have understood it a bit better, but they just said we will keep an eye on it every 6 months. You know, keeping an eye on it could mean a blood test, a meeting with the consultant, another biopsy. I was in the dark and it is the not knowing, the lack of information, that is what worries you”. (Interviewee 13, aged 71)
|
The need for additional support in the form of a support group
|
The men interviewed explained their access to Prostate Cancer experts is limited and therefore access to a group of men also under active surveillance would be helpful.
|
“You know, you see the hospital doctors very infrequently so for me I always viewed my GP, who I have known for years, as my first port of call when I needed to better understand things relating to active surveillance and my tests and stuff. But the problem I found was, and I don’t mean to be rude, he [the GP] didn’t know any more about active surveillance than me so you are kind of left in this horrible place where no one has the ability to answer your questions or fears so meeting up with other chaps on active surveillance in a confidential and educationally focused group would be a real coup for me” (Interviewee 12, aged 58).
|
The need for additional support in the form of a website
|
Men wanted to play an active part in helping themselves and would value self-management information in the form of a website.
|
“If prostate cancer specific information was available on the web, then that reassures people. Things like frequently asked questions, situations and symptoms to look out for, advice on what you can do to help manage it [prostate cancer], advice about diet, changes that I ought to be making. Things of that nature really, things to allow me to self-manage this [prostate cancer]” (Interviewee 1, aged 71).
|
Implications for PROACTIVE development
The results from this qualitative study indicate that men being managed with active surveillance would welcome specific additional psycho-educational support to help them better cope and manage with the burden of living with untreated prostate cancer. According to the data, a mixture of web-based support and group session support would be most appropriate.
Intervention Design
Key guiding principles
Using the information gathered during the intervention planning phase, the research team developed a set of key guiding principles, in line with the PBA approach. The purpose of this is to summarise the design objectives and how these will be achieved, to facilitate quick and easy reference throughout the planning and development phase to guide and focus the decision making around intervention content and design(13). Table 4 outlines the three intervention design objectives along with the key features of the intervention designed to address each objective.
Table 4: Key Guiding Principles
Intervention design objective
|
Key features designed to address objective
|
Rationale for design objective and key features
|
- To support men to manage the anxiety they experience due to being on active surveillance.
|
The group sessions should provide support with anxiety by providing reassurance and normative information about others’ experiences, and encouragement in the development of coping skills (for example, social support mobilisation). The web component should complement the group sessions, enabling men to learn self-management strategies to take control of their anxiety. The web component should also signpost men to further reliable information available online.
|
- All research conducted in the planning phase indicated emotional distress.
- The qualitative study with the target audience, and various previous interventions (22-27, 29) indicated group support may be beneficial.
- The qualitative study indicated a lack of reliable PCa and AS related information.
|
- To encourage and support a healthy lifestyle.
|
The web component should provide information about diet, physical activity and stress management to encourage a healthy lifestyle. Asking the men to set weekly goals could encourage them to utilise the information and implement changes to benefit their health. Relaxation techniques to be demonstrated in the group sessions, and the lifestyle information reinforced.
|
- Target audience in qualitative study requested self-management tools/advice.
|
- To maximise engagement in the programme.
|
In order to encourage participation from men who might usually feel uncomfortable participating, and to minimise withdrawal from the group sessions, the group sessions need to be facilitated in a way that encourages active participation, mutual understanding, respect and help-seeking behaviour (for example, demonstrating an interest for further information). To encourage men who might otherwise not participate the group facilitator needs to sensitively encourage patients to identify their emotional state and feelings.
|
- Important to maximise engagement in the programme to maximise change / improvements.
|
Developing a logic model
The MRC complex intervention guidelines(35) recommend the development of a logic model to outline the hypothesized causal mechanisms involved in bringing about change in men on AS for PCa. The logic model (Figure 1) demonstrates how we anticipate the intervention will result in improved psychological wellbeing.
Figure 1: Logic Model
Public and patient involvement
Three Patient and Public Involvement (PPI) contributors with PCa were involved in the intervention planning and development process. The research team met with the contributors every 4-8 weeks to provide progress updates and gain feedback on ideas and written materials. PPI contributors reviewed and commented on the online and workshop content and were involved in all key decisions. The involvement of the PPI contributors ensured developing study materials were likely to be acceptable, understandable and relevant to the target audience.