Effectiveness of web-based intervention on reducing symptom burden, improving self-management capabilities and self-efficacy among prostate cancer survivors: a systematic review and meta-analysis protocol

Abstract

Introduction

Prostate cancer is the most common malignant disease within the male genitourinary system. Advances in cancer screening and treatment have significantly ameliorated the survival rates of patients with prostate cancer. Nonetheless, prostate cancer survivors report various degrees of cancer-related symptoms. These symptoms cause physiological and psychological suffering, leading to a deterioration of quality of life. Web-based interventions may facilitate the management of symptoms due to their flexibility, accessibility and convenience. However, the efficacy of web-based interventions in reducing symptom burden remains to be confirmed. Consequently, this systematic review and meta-analysis aims to comprehensively synthesise existing evidence, evaluate the effectiveness of web-based interventions in reducing symptom burden among patients and furnish a reference for clinical practice.

Methods and analysis

This protocol strictly adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol guidelines. We will comprehensively search six databases (PubMed, Web of Science, Cochrane, Embase, CINAHL and PsycINFO) from their inception to March 2024 in order to identify clinical trials on the efficacy of web-based interventions for prostate cancer survivors. Two reviewers will independently conduct study selection, data extraction and quality assessment. The risk bias of included studies will be assessed using the Cochrane Risk of Bias Tool for randomised trials 2.0, and the strength of evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE) guideline. Meta-analysis will be performed using STATA V.16.0, and the effect size will be calculated using the standardised mean difference and its 95% CI. Heterogeneity will be assessed using Cochran’s Q statics and inconsistency will be measured using the I² statistics. Potential sources of bias will be evaluated.

Ethics and dissemination

Ethics approval is not required for this review as no human participants will be involved. The results will be disseminated via a peer-reviewed journal or an academic conference.

PROSPERO registration number

CRD42023457718.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• This systematic review protocol strictly follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines.

• The review process will adhere to rigorous methods, involving a minimum of two independent reviewers who will be responsible for study selection, data extraction and quality assessment.

• Variability exists in the tools used for assessing and reporting PC-specific symptoms, self-management capability and self-efficacy, leading to inherent differences in sensitivity and specificity.

• There is a limited availability of research results from randomised controlled trials due to the emerging nature of web-based self-management interventions among prostate cancer survivors.

• This study may have potential language and publication biases because publications in languages other than English and grey literature are excluded.

Introduction

According to the Global Cancer Statistics 2020,¹ prostate cancer is the second most prevalent cancer among men worldwide, and the most common malignant tumour of the male genitourinary system. It is projected that by 2040, the incidence of prostate cancer will increase to nearly 2.3 million new cases, resulting in 740 000 deaths, primarily due to population ageing.²

Although the incidence of prostate cancer is high, the mortality of prostate cancer is relatively low.³ Research has indicated that patients with prostate cancer can achieve positive survival outcomes through surgical interventions, radiation therapy, chemotherapy, hormone therapy and combined treatment modalities.⁴ According to the statistical data from Surveillance, Epidemiology and End Results (SEER), USA, the 5-year relative survival rate for patients with prostate cancer is 97.1%.⁵ However, regardless of the treatment method employed, patients with prostate cancer will inevitably experience various physical symptoms, including urinary dysfunction (such as urinary incontinence, difficulty urinating, increased frequency of urination and urinary retention), gastrointestinal dysfunction (such as diarrhoea, rectal bleeding and proctitis), sexual dysfunction and hormonal disturbances (breast swelling, nipple pain, hot flashes, decreased bone mass and metabolic disorders, etc)^{6 7} The most common and severe adverse reactions typically occur within 6 months to 1 year after treatment and may persist for 4–8 years.⁸ This means that prostate cancer survivors will be severely troubled by the symptoms for a considerable period of time, which will contribute to psychological distress such as depression and anxiety. These physiological and psychological burdens result in a low quality of life for prostate cancer survivors.⁹ Of even greater concern is the stress that this imposes on the patients’ families and society as a whole. According to research findings, caregivers of prostate cancer survivors reported clinically significant levels of anxiety, depression, fatigue and deteriorated physical health, as they undertook more caregiving responsibilities.^{10 11} Due to the deteriorating health of caregivers, their ability to provide support declines, which has a detrimental impact on the patients’ health.¹² Furthermore, the upward trend in prostate cancer incidence and the diverse treatment side effects pose a strain on the healthcare system, necessitating increased allocation of resources for the purposes of long-term care. This augmented burden consequently gives rise to extended patient waiting times, diminished availability of specialised care and escalated healthcare expenditures. Consequently, heightened endeavours are imperative in the realms of long-term care and rehabilitation of prostate cancer survivors to ameliorate this challenging situation.

Self-management of symptoms is deemed necessary for prostate cancer survivors.¹³ Since the care for prostate cancer survivors is predominantly conducted in outpatient settings, there are time and location constraints on the interactions between patients and healthcare service providers. Consequently, patients assume a greater responsibility in managing their ongoing symptom care.¹⁴ However, they often lack structured training to acquire proficient management strategies, resulting in inefficient symptom control and potential exacerbation of harm due to suboptimal management practices.¹² A large-scale study conducted in the UK indicates that over 80% of males reported poor or very poor sexual function after treatment, with approximately 56% of males not receiving any interventions to address this issue.¹⁵ Patients have reported unmet informational needs related to prostate cancer recurrence, the impact on their spouse/partner and long-term effects/recovery associated with prostate cancer.¹⁶ Long-term prostate cancer survivors require more supportive information.¹⁷ Self-management, by activating the engagement of prostate cancer survivors, appears to be an effective solution to the aforementioned challenges. Traditionally, cancer care has followed a paternalistic paradigm, where healthcare providers dictate to patients and expect compliance.¹⁴ Self-management, defined as the ability to manage the symptoms and consequences of living with a chronic condition, including treatment, physical, social and lifestyle changes¹⁸, transforms traditional paternalistic into a collaborative partnership model, changing the way information is delivered and the relationship between patients and information providers, and empowering patients and their families with the necessary skills and knowledge to care for themselves during cancer treatment and recovery.¹⁴ When patients feel capable of controlling their own symptoms and seek help from appropriate medical professionals, their suffering can be alleviated.¹⁴ Presently, interventions aimed at augmenting the symptom self-management capability of patients and caregivers are predominantly conducted by trained healthcare professionals within clinical settings or through home visits, with durations ranging from several weeks to months.^19–25 Although these interventions have proven effective, it is self-evident that their extensive implementation in the existing healthcare landscape poses challenges due to substantial demands on human resources and financial investment. Consequently, the adoption of more cost-effective approaches becomes imperative.¹²

The development of communication technology and the widespread adoption of emerging digital devices globally have provided new perspectives for self-management. Particularly, web-based interventions using devices such as smartphones and laptops are increasingly recognised as cost-effective alternatives to traditional face-to-face therapy, owing to their high portability, accessibility, flexibility and efficiency.²⁶ By circumventing the limitations of time and space typically associated with in-person interventions, web-based interventions offer more convenient access for participants, reaching a broader range of populations.²⁷ Facilitating a closed loop between patients and healthcare professionals, these interventions address the unequal distribution of healthcare resources and contribute to the realisation of universal healthcare coverage.²⁸

Currently, web-based individual or dyadic self-management interventions are widely used among cancer survivors.²⁹ These interventions typically consist of multiple modules, including self-reporting or consultation, education, information acquisition, sharing, tracking and diary.²⁹ Through these modules, patients are able to provide feedback on their condition to experts, gain knowledge on symptom management, psychological issues and other cancer-related concerns, as well as access cancer-related resources. Additionally, patients can share experiences with one another and keep track of treatment progress and personal notes. Several systematic reviews and meta-analyses have provided evidence that web-based self-management interventions have a positive impact on patients with cancer. These interventions have been found to improve cancer-related fatigue, reduce symptom distress, lower levels of anxiety and depression, improve sleep quality, and enhance self-efficacy.^29–31 A review of web-based binary interventions further supports the feasibility, usability and acceptability of these interventions. It also suggests a positive trend in the effects of web-based interventions on self-efficacy, quality of life, physical and mental health, as well as dyadic relationships among cancer survivors and their caregivers.³²

In the field of prostate cancer, research has been initiated to investigate the potential impact of web-based interventions on survivors and caregivers. Several clinical trial results have indicated that web interventions play a positive role in improving urinary system symptoms, alleviating anxiety, enhancing self-efficacy, improving coping strategies and enhancing the quality of life in prostate cancer survivors.^{12 33 34} There are some narrow or scoping reviews that have demonstrated the potential effectiveness and feasibility of web-based interventions.^{35 36} Two systematic reviews and meta-analyses, each including ten studies, have assessed the effectiveness of web-based interventions. Their findings suggest that web-based interventions are effective in improving cancer-related stress, anxiety, depression and quality of life in prostate cancer survivors.^{31 37} However, none of the reviews provided quantitative estimates of the effectiveness of web-based interventions in improving symptom burden and enhancing self-efficacy, health literacy and self-management ability. Additionally, none of the reviews conducted subgroup analyses on different forms of web-based interventions to determine the most suitable approach for prostate cancer survivors. Therefore, it is necessary to conduct systematic reviews and meta-analyses to comprehensively analyse the existing evidence and delve deeper into the effectiveness of web-based interventions in reducing cancer-related symptoms, enhancing self-efficacy and improving self-management capabilities in patients. Furthermore, special attention should be given to web-based technologies to further elucidate which types of interventions are effective for prostate cancer survivors, thus providing scientific evidence for future clinical practices.

Objectives

This systematic review and meta-analysis aims to:

1. Investigate the effectiveness and cost-effectiveness of web-based interventions in enhancing self-symptom management strategies for prostate cancer survivors by integrating all available evidence from randomised controlled trials (RCTs).

2. Provide novel insights into the potential impact of interactive type, format type, technological type of web-based interventions and socioeconomic status of survivors on intervention outcomes, identify the most effective approach, ultimately leading to the identification of an optimal web-based intervention strategy.

Methods and analysis

Registration and study design

This paper introduces a systematic review protocol that has been registered in PROSPERO (CRD42023457718), and any future changes will be registered as amendments. We will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines³⁸ to complete and report the study protocol (see online supplemental table S1 for details). The research questions are developed based on the PICOS framework (Population, Intervention, Comparison, Outcome and Study design), which will be described in detail in the following.

Eligibility criteria for selecting studies

Types of study

Studies designed as RCTs that have been published in peer-reviewed journals written in English will be considered eligible. We will exclude single-group studies, reviews, case reports, cohort studies, letters to editors, conference abstracts and study protocols.

Types of participant

The population of this study should be men with prostate cancer but without severe diseases (disease in the terminal stage) whether they are treated. Patients with any disease that hinders the trial such as severe cognitive impairment will also be excluded.

Types of intervention

The intervention modality should involve any web-based approach to provide self-management strategies. The devices may include, but are not limited to, computers and smartphones while the delivery channels may include, but are not limited to, websites and mobile applications.

Types of comparator

All the controls including conventional care or waitlist comparison groups will be regarded as eligible. Studies of control groups receiving no interventions will be excluded.

Types of outcomes

Prostate Cancer (PC)-specific symptoms are the primary outcomes of interest for this review, caused by cancer and its treatments, including urinary symptoms, bowel symptoms, sexual symptoms and hormonal symptoms.

The following secondary outcomes are of interest:

1. Behavioural outcomes: self-management behaviours (mainly including physical activities, healthy diet, positive engagement, skill acquisition, active self-monitoring).

2. Cognitive and attitudinal outcomes: disease knowledge and self-efficacy.

3. Mental health: depression and anxiety.

4. Quality of life.

5. Utilisation and cost of medical services.

   Studies that included at least one of these outcomes will be considered eligible.

Search methods and search strategy

This study will conduct a search across six databases, including PubMed, Web of Science, Embase, Cochrane Library, CINAHL and PsycINFO. The search time frame will include all relevant studies published from the inception of the databases up until March 2024. All relevant studies that meet the criteria will be included.

The search strategy will be constructed using a combination of Medical Subject Heading terms and keywords, following the PICOs framework that encompasses population, intervention, comparison, outcomes and study design. The detailed search strategy for PubMed search is presented in online supplemental table S2.

In addition, relevant literature that meets the inclusion criteria from the reference lists of included studies will also be considered for inclusion in this research.

Study selection

After a systematic search, all literature will be imported into EndNote software, and the duplicate references will be removed using the software’s deduplication function. Subsequently, one researcher will manually identify and delete any duplicate references. According to the selection criteria previously determined, two independent researchers will screen the title and abstract of all identified studies for eligibility to view the full text. Finally, studies requiring further analysis will be selected. Any discrepancies will be discussed and resolved in consultation with the third researcher. Reasons for excluding studies will be detailed on a PRISMA flow chart.

Assessment of risk bias

The Cochrane Risk of Bias Tool for randomised trials 2.0³⁹ will be used to assess the risk of included studies. This tool assesses the following domains:

1. Bias arising from the randomisation process.

2. Bias due to deviations from intended interventions.

3. Bias due to deviations from intended interventions.

4. Bias in measurement of the outcome.

5. Bias in selection of the reported result.

Two independent reviewers will assess each domain of the included studies, which will be categorised as low, high or some concerns. In cases of disagreement, consensus will be reached through negotiation, and if necessary, a third reviewer will make the final decision.

Strength of evidence

The Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines will be used to evaluate the overall strength of evidence among the included studies. After evaluating the design, study limitations, consistency, directness, precision and publication bias, the quality of evidence will vary between high, moderate, low or very low, depending on the confidence in the effect estimate.

Data extraction

We will extract the specific information using the predesigned and structured template. Two independent reviewers will extract the information and check for accuracy by a third reviewer. We will contact the authors of the included studies with any missing, uncertain or incomplete information to get exact results. We will extract the following information:

1. The general information: the first author, publication years, country and study design.

2. Participants details: mean age, treatments, socioeconomic status and sample sizes.

3. Intervention details: detailed regimen, duration, main technology and interaction.

4. Control group regimen.

5. Outcomes: the primary and secondary outcomes.

6. Attrition rates.

Data synthesis and analysis

In our analysis of the included literature, we will provide a summary of the authors, publication year, intervention type, intervention time, measurement tool, measurement unit, mean difference (MD), SD and sample size. All relevant outcomes will be presented in tables and analysed as continuous variables. When the measurement tools and units are consistent, we will use a 95% CI for MD. Otherwise, a 95% CI for standardised MD (SMD) will be used. The effect size will be evaluated according to Cohen’s standards, where SMD values between 0.20 and 0.50 will be considered small, between 0.50 and 0.8 will be considered moderate, and 0.8 or greater will be regarded as large. All statistical calculations will be performed using Stata V.16.0 software, with a significance level set at p<0.05.

The heterogeneity among the studies will be assessed using both the χ2 test and I² test. According to the guidelines in the Cochrane Handbook, an I² value of 0%–40% indicates no significant heterogeneity, 30%–60% suggests moderate heterogeneity, 50%–90% signifies substantial heterogeneity and values exceeding 75% indicate high heterogeneity. If there is no significant heterogeneity (p≥0.1 for χ² test and I² value ≤50%), we will use a fixed-effects model for the analysis. Otherwise, a random-effects model will be employed.

To identify potential sources of heterogeneity and explore optimal web-based intervention approaches, we will conduct subgroup analyses based on intervention modality, intervention interactiveness, intervention duration, economic level and other relevant factors. If we have an adequate number of studies (at least 10), we will also perform meta-regression to examine factors such as age, treatment and more that may contribute to heterogeneity.

Validity, reliability and rigour

We followed the PRISMA-P guidelines³⁸ to develop the protocol for this systematic review. In conducting and reporting the review, we will strictly adhere to the Cochrane Handbook and follow the best practice PRISMA guidelines.

Patient and public involvement

Patients and the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

Ethics and dissemination

This systematic review and meta-analysis does not require ethics approval. The data presented in the paper are abstracted from published literature. The results of the study will be disseminated through peer-reviewed publications and conferences.

Ethics statements

Patient consent for publication

Not applicable.