Psychological Intervention Improves Quality of Life, but Not Survival in Patients with Early-Stage Cancer: a Systematic Review and Meta-analysis of randomized clinical trials

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Psychological Intervention Improves Quality of Life, but Not Survival in Patients with Early-Stage Cancer: a Systematic Review and Meta-analysis of randomized clinical trials

https://doi.org/10.21203/rs.3.rs-3407894/v1

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The effectiveness of psychological interventions (PI) for malignant diseases is still controversial. Our aim was to investigate the effect of PI on survival and quality of life (QoL) in patients with cancer. We performed a systematic search of MEDLINE, Cochrane, and Embase databases to identify randomized controlled trials comparing PI to standard care (PROSPERO registration number CRD42021282327). Outcomes were overall survival (OS), recurrence-free survival (RFS), and different domains of QoL: global, emotional, social, and physical. A subgroup analysis was performed based on provider, type, environment, duration, and cancer stage of intervention. Pooled hazard ratios (HR) and standardized mean difference (SMD) with 95% confidence intervals (CI) were calculated using a random-effects model. We found 129 articles eligible for data analysis. The OS and RFS did not differ significantly between the PI and the standard care groups (OS: HR=1.01; CI: 0.95-1.07; RFS: HR=0.99; CI: 0.84-1.16). However, our analysis showed significant improvements in the intervention group in all the analyzed domains of QoL; in the global (SMD=0.84; CI: 0.37-1.31), emotional (SMD=0.52; CI: 0.20-0.83), physical (SMD=0.45; CI: 0.11-0.79) and social (SMD=0.34; CI: 0.08-0.60) domains. Importantly, the effect of PI on QoL was generally positive immediately, 12 and 24 weeks after intervention, but PI decreased over time, and was no longer found significant at 48 weeks. The results were better in early stages of cancer. Psychological interventions do not prolong survival, but they significantly improve the QoL of cancer patients. Our results suggest that PI should be standard of care for 3-4 times a year at least for patients especially with early-stage cancer.

Biological sciences/Cancer

Biological sciences/Psychology

Health sciences/Health care

Health sciences/Oncology

neoplasm

survival

quality of life

psychosocial intervention

Cancer is a leading cause of death and reduces life expectancy worldwide. [1] GLOBOCAN estimated that there were 19.3 million new cancer cases, and almost 10 million led to death in 2020, irrespective of the world region. [2] In Europe, the most common causes of cancer-related deaths are lung (380,000 deaths, one fifth of the total), colorectal (250,000 deaths, 12.6%), breast (140,000, 7.3%; females only) and pancreatic (130,000, 6.8%) cancers. Altogether, these cancers account for 47% of all cancer-related mortality. The disease affects not only a large number of patients, but also their families and the healthcare system, taking psychological, physical, and financial toll. [3]

Survival used to be almost the only goal of cancer treatment; however, quality of life (QoL) is increasingly recognized as an important outcome criterion for oncological treatments and has been linked to the prediction of survival. [4] Receiving a cancer diagnosis unquestionably has a negative impact on the QoL, which is related to the prognosis of the disease itself, the choice of treatment, and the duration of the disease. The need for frequent hospitalizations, negative emotions, and several symptoms significantly reduce the QoL of these patients. [5] For these reasons, the need for psychosocial interventions to treat and support these patients as well as cancer survivors has increased recently. [6] The exact effect of how psychological interventions can improve QoL and prolong survival is inconclusive. Existing studies are based on small samples and are inconsistent in terms of intervention provider, delivery methods, intervention type, duration, and intensity, follow-up measurement periods, and methodological quality. [7–10]

Here, our aim was to investigate survival and QoL of patients with cancer who underwent standard care with psychological interventions. Further our aim was to provide information in the most comprehensive way in one study regarding cancer stage, interventions’ provider, environment, type and duration.

The recommendations of PRISMA 2020 [11] and Cochrane Handbook guidelines were strictly applied (PROSPERO registration number CRD42021282327) [12].

Search strategy

We formulated our clinical question and defined the search strategy using the PICO-S (population, intervention, comparison, outcome, study type) framework. The systematic search was performed in three databases: MEDLINE (via PubMed), Cochrane Library (CENTRAL), and EMBASE from inception until 18th October 2021, without restrictions. The search key (Supplementary Information (referred to as S.) Table S.1) with the following main concepts: psychotherapy AND cancer AND randomized - was used to identify the eligible articles according to predefined criteria. We also screened the reference lists of the identified articles for further eligible reports.

Eligibility criteria

Only randomized controlled trials (RCTs) were considered eligible; patients diagnosed with any cancer who received psychological interventions were included in our analysis if data on their survival (overall (OS), recurrence-free (RFS)), or QoL were provided. Regarding the psychological interventions, various methods were eligible for the study: different types of psychotherapy, mindfulness, cognitive-behavioral therapy, relaxation, meditation, stress management, self-help, psychoeducation, and counseling; carried out in a group, individual or guided self-help settings; face to face, on the telephone, or via the internet. Interventions carried out by psychologists, nurses, or any type of non-specified healthcare professional were also eligible. These categories are described in detail in the Supplementary Information - Section S.2. We included only full-text publications in peer-reviewed journals.

Selection and data extraction

After duplicate removal and exclusion based on titles and abstracts, 762 articles were screened in more detail for eligibility. Subsequently, another 450 were excluded because of missing outcome parameters, which resulted in 129 articles analyzed in this study. The complete search and selection process is described in Section A3. and is shown in the PRISMA flowchart Figure S.1. The following data were extracted: publication characteristics: first author, year of publication, country of origin, number of centers, demographic characteristics of the study population, intervention characteristics: type, duration, provider, environment, outcomes – overall and progression-free survival, quality of life – measurement tool, time of the measurements, net minutes of intervention per patient, questionnaire scores - as reported in each article. The outcomes of our analysis of the subgroups are summarized in Fig. 1. A detailed explanation of the structure is given in Section S.2. Baseline characteristics of the enrolled studies are detailed in Table A2.

Statistical analysis

As we anticipated considerable between-study heterogeneity, a random-effects model was used to pool effect sizes.

For OS and RFS, pooled hazard ratios (HR) with 95% confidence intervals were calculated using an inverse variance weighting method, heterogeneity was estimated using a restricted maximum-likelihood estimator, with the Q profile method for the confidence interval. For QoL, due to differences in the questionnaires measuring the outcomes, the standardized mean difference (SMD) with a 95% confidence interval (CI) was used as the effect size between the intervention and the control groups. We used Hedges' g to calculate SMDs.[13] SMD values of 0.2–0.5 were considered as small effects, values of 0.5–0.8 were considered medium effects, and values > 0.8 were considered large effects. As the articles reported QoL results at different follow-up time points, to make a prediction, we created a longitudinal model for predicting QoL at 0-, 12-, 24-, and 48-weeks post-intervention, using the time and the square of time as predictors of change in time. Forest plots illustrate the results at these specific time points (T0 = week 0, T12 = week 12 T24 = week 24, T48 = week 48). A separate longitudinal prediction-model was applied for different QoL domains and subcategories. The summary plots are used to visualize the calculated overall effects for a given outcome. Inverse variance weighting was used to calculate the pooled SMD in the longitudinal meta-analysis.

Publication bias and small study effects were assessed using funnel plots. All statistical analyses were made with R (v4.2.1) [14] using the following packages: metafor (v3.4.0) [15] and clubSandwich (v0.5.8) for model calculations, publication bias and influential assessment, meta (v5.5.0) [16] for forest plots, ggplot2 (v3.3.6) [17] for additional prediction plots. A detailed description of our statistical analysis is given in Section A4. We report the results as point estimates of the effect size (lower - upper limit of 95% CI) format.

Study risk of bias and certainty assessment

Two authors (ASB and NV) independently performed the risk of bias assessment using the Cochrane risk-of-bias tool for randomized trials Version 2 (RoB 2). [18] Disagreements were resolved by a third party (BF).

1. Psychological interventions do not affect survival

Twelve studies reported on the OS, involving 2,294 patients, and 5 reported on RFS involving 900 patients. The OS of patients did not differ significantly between the intervention and the control groups (HR = 1.01; 95% CI = 0.95–1.07). Similarly, there was no significant difference in RFS between the two groups (HR = 0.99; 95% CI = 0.84–1.16) (Fig. 2).

2. Longitudinal meta-analysis: post-intervention (T0) results

2.1. Psychological interventions significantly improve quality of life in all measured domains.

Here, we present the results of model-based prediction values for the overall post-intervention effect sizes. In the intervention group, we found significant improvements compared to the control group in all analyzed domains of QoL: global (SMD = 0.84; 95% CI = 0.37–1.31), emotional (SMD = 0.52; 95% CI = 0.20–0.83), social (SMD = 0.34; 95% CI = 0.08–0.60) and physical (SMD = 0.45; 95% CI = 0.11–0.79) domains (Fig. 3). A forest plot of the pooled results for each domain at different time points is presented in Figure S.2.

2.1.1. Subgroup analysis of global QoL

On the basis of the subgroup analysis structure mentioned earlier, we found significant improvement (T0) in the intervention group in all categories of providers: psychologist SMD = 0.66; CI = 0.14–1.17), healthcare professional (SMD = 0.99; CI = 0.14–1.49), and nurse (SMD = 0.93; CI = 0.30–1.55). In the environment category, significant improvements were observed for face-to-face (SMD = 0.89; CI = 0.41–1.37) and online (SMD = 0.87; CI = 0.00-1.74) intervention, but no improvement was seen when the intervention was delivered via telephone (SMD = 0.55; CI = 0.64–1.74). In the category of intervention type, we found that there was significant improvement in the experimental group for individual (SMD = 0.87; CI = 0.38–1.35) and group therapy (SMD = 0.80; CI = 0.30–1.31), but the guided self-help therapy (SMD = 0.84; CI=-0.05-1.72) also showed a large clinical effect. Significant improvements for cancer stage were only seen when patients were in the early stages of cancer (SMD = 0.76; CI = 0.07–1.44) (Fig. 4). Individual study effects and measured time points are shown in Figures S. 3–6.

2.1.2. Subgroup analysis of emotional QoL

Patients receiving psychological intervention had significantly improved quality of life regardless of the provider: psychologist (SMD = 0.36; CI = 0.03–0.68), healthcare professional (SMD = 0.53; CI = 0.20–0.87), and nurse (SMD = 0.75; CI = 0.30–1.20). The results showed significant improvement in the category environment in the experimental group when the intervention was delivered face to face (SMD = 0.54; CI = 0.15–0.92) or online (SMD = 0.66; CI = 0.08–1.23). There was no improvement when the intervention was via telephone (SMD = 0.34; CI=-0.08-0.76). There was a significant improvement in the type of intervention, for the individual (SMD = 0.48; CI = 0.12–0.84) and group-based interventions (SMD = 0.57; CI = 0.07–1.07). There was no difference when the type of intervention was guided self-help (SMD = 0.59; CI=-0.78-1.97). Significant emotional QoL changes were only observed in the early-stage cancer group (SMD = 0.77; CI = 0.05–1.50) (Fig. 5). Individual study effects and the other time points are shown in Figures S.7–10.

2.1.4. Subgroup analysis of social QoL

Our analysis showed a significant improvement in social QoL in the subcategory nurse-delivered intervention (SMD = 0.46; CI = 0.0.16–0.76) for the provider subgroup. The most effective environment was face-to-face intervention (SMD = 0.35; CI = 0.07–0.64), and there was a large improvement only when the intervention was individual (SMD = 0.38; CI = 0.11–0.66). Finally, there was no improvement in social QoL by cancer stage (Fig. 6). Individual study effects and the other time points are shown in Figures S.15–18.

2.1.3. Subgroup analysis of physical QoL

Physical QoL improved significantly in the intervention group compared to the control group in two categories of providers: psychologists (SMD = 0.54; CI = 0.03–1.05), and healthcare professionals (SMD = 0.47; CI = 0.11–0.83). Significant differences were only found in the environment category when the intervention was delivered face to face (SMD = 0.48; CI = 0.09–0.88). In the category type, only the individual (SMD = 0.41; CI = 0.09–0.74) intervention had a significantly better effect There was no notable improvement in cancer stage (Fig. 7). The effects of individual study and data for the other time points are shown in Figures S.11–14.

2.2. Impact of the interventions over time in the four domains of quality of life

The post-intervention intervention had a significant effect, but the effect of follow-up time was not found significant. However, the point estimate decreased slightly during the follow-up time, and the 95% CI for the 48-week effect was the 0 effect (Fig. 8). The significant baseline improvement measured at the estimated time 0 t did not decrease before week 48. By week 48, the improvement had disappeared in almost all domains except for physical QoL. Regression plots for each domain are shown in Figure S.19.

2.3. Duration of intervention

Our analysis showed that, based on the duration of the intervention (net minutes/patient), QoL SMDs did not change significantly by each week in any domain (Fig. 9). (Global QoL: SMD = 1.14; CI = 0.4–1.87 /min; emotional QoL: SMD = 0.73; CI = 0.04–1.42 /min, social QoL: SMD = 0.33; CI=-0.23-0.89 /min; physical QoL: SMD = 0.31; CI=-0.31-0.92 /min).

Systematic review part

Thirteen studies reported on global QoL and nine studies [19–27] reported improved QoL in the intervention group compared to the control group. For emotional QoL, five out of seven studies [19–21, 28, 29] reported improvement in the intervention group. For physical QoL, two out of three studies [26, 27] reported that scores in physical domains improved in the intervention group. For social QoL, three out of five studies [19, 21, 28] reported better QoL scores in the intervention group than in the control group. These studies were not included in the meta-analysis because of missing data.

Risk of bias assessment

The detailed results of the risk of bias assessment are presented in Table S.20. For survival and QoL, most of the studies had some concerns about the risk of overall bias mainly due to the randomization process.

Publication bias and heterogeneity

For OS, we could observe a possible publication bias of small studies, but the effect of small studies does not change the conclusion to a relevant extent. In the case of RFS, the assessment of publication bias of small studies is limited as the number of studies is very low (S.21.1.-S.21.2.). For QoLs, the funnel plots do not exclude the presence of potential publication bias, although the figure suggests a few outlier publications rather than systemic reporting bias (see S.21.3.- S.21.6.).

Statistical heterogeneity of survival data was considered moderate: OS: I² = 3% [0%,60%]; RFS. I² = 23% [0%,68%].

The psychosocial difficulties experienced by cancer patients in the long term are broad and include a wide range of symptoms such as anxiety, uneasiness, mourning, helplessness, fatigue, concentration difficulties, sleep problems, mental and cognitive impairments, sexual dysfunction, psychological distress, and psychiatric illnesses. [30] These symptoms are even more common in patients with poor prognosis and advanced stage of cancer. [31] Therefore, the above-mentioned psychosocial symptom-free period and QoL have become the primary endpoints. [32] Firkinns et al. [33] found that QoL was significantly affected 2 to 26 years after cancer diagnosis. This means that providing psychological support to cancer survivors is crucial.

Although our analysis concluded that psychological interventions do not prolong survival time, psychological interventions can improve the quality of life of patients and the time that these patients and their families have left. This is why our findings are important and why they raise awareness of QoL in these patients. Our analysis revealed significant improvements in all four measured QoL domains (global, emotional, social, and physical) in the intervention group compared to the control group.

Moreover, our subgroup analysis showed significant improvements in the global and emotional QoL in the experimental group regardless of the provider of the interventions, from moderate to high clinical effects. This suggests that the relationship matters regardless of who provides the interventions. We would also like to note that the interventions used in the studies were mostly non-psychotherapies, where the role of the psychologist was essential. Personalized interventions can reduce the psychological burden on the patients, and healthcare professionals.

The environment in which the interventions take place also influences the beneficial effect. Our analysis showed that in the global and emotional domains, the face-to-face and online interventions were most effective. This suggests that personal interactions are important factors in the delivery of psychological interventions. However, an online form can also be effective if, for example, a patient has difficulty going to hospital.

In terms of the type of interventions, there were significant improvements for individual and group-based therapies; however, guided self-help also had a large clinical effect.

It has been proposed that psychological interventions only affect the prognosis of patients with early-stage cancer, as the natural course of more advanced stages might obviate the possible effect of psychosocial factors. [8] Our results may support these findings as the point estimates were higher for early-stage patients, but it did not prove significant. The results for cancer stage suggest that psychological interventions are most effective when provided in the early stages, rather than in the advanced or the survival phase. Our results suggest that psychological interventions should be used in standard care from the time of the diagnosis. An interesting finding is that these interventions did not affect the survival category. These patients may have gone through post-traumatic growth, and these interventions are not strong enough for them to make a difference. We must highlight that we had limited data to analyze the detailed stage of cancer.

In the QoL provider subgroup, there were improvements in the physical domain for psychologists and healthcare professionals, but in the QoL social domain, we only saw a positive effect for interventions provided by nurses. In the environment subgroup, only face-to-face therapy significantly affected QoL in both domains. We can conclude that face-to-face interventions are more effective in treating psychological problems and should be part of the standard treatment if the condition of the patient allows it.

Only the individual type of interventions showed significant improvements in both QoL domains. Participating in group therapy where fellow patients are suffering from the same condition in a worse condition might be frightening to see. It is also possible that heterogeneous groups make it difficult to tailor the best possible treatment for each patient group. For this reason, individual therapies are a better choice. For the guided self-help type, we had limited data to draw conclusions.

There were no significant improvements in physical and social QoL in any cancer stage. It is most probably due to the limited amount of data.

Interestingly, our results showed that the duration of the intervention is not an important factor for psychological interventions in improving the four analyzed QoL domains. Due to the heterogeneity of interventions, we were not able to analyze data by duration, frequency and occasion and further research is needed in this subgroup. This is, however, an important finding for future recommendations and fundings, as we could standardize short but intensive interventions at least three or four times a year to be cost- and time-effective when treating these patients for their QoL. Figure 10. shows the sum of the subgroup analysis of QoL domains.

Our results suggest that psychological interventions are effective and should be introduced into the routine care of oncological patients. We have gained important information based on provider, type, environment, cancer stage, and duration of intervention efficacy that can be used to improve the effectiveness of psychological interventions. However, our results also showed that patients have different needs; therefore, we should strive to provide personalized patient care.

Even though the survival analysis did not show significant differences between the two groups based on the limited amount of data; our results provide evidence for the beneficial effect of psychological interventions on several aspects of QoL in patients with cancer. While medical research puts the emphasis on survival as it is the hardest outcome, QoL plays as important role in individuals’ life as mortality and should not be underestimated. A longer life in suffering is not necessarily better than a shorter one spent in a better well-being. For that reason, in clinical practice, the assessment of QoL should be an essential part of routine care in order to provide personalized psychological treatments.

Strengths and limitation

One of the strengths of this work is its absolute objectivity, which was performed using meta-analyses and rigorous methodology. We were able to provide the highest level of evidence available by including only RCTs with a large number of enrolled patients. To our current knowledge, this is the most comprehensive meta-analysis to report on the effectiveness of psychological intervention by provider, environment, type, and cancer stage subgroup. Although the results of this meta-analysis seem promising, the conclusions should be interpreted with caution. In terms of limitations of this work, the first and most important to note is the heterogeneous study/clinical settings between the included studies, in particular, the different types of interventions, cancer types and measurement tools. These differences made it necessary to use less sensitive statistical analysis. Criteria were developed to define psychological interventions; however, these terms and methods can be often used interchangeably, and the distinction may be subjective. This is further aggravated by insufficient details on interventions; therefore, decisions on inclusion or exclusion may also be superficial. [7] For the survival analysis we could only rely on a small amount of data, so conclusions should be drawn carefully for that. Lastly, a further limitation is the presence of moderate to high risk of bias in some areas.

Implications for practice and research

Implementing scientific results in everyday clinical practice is crucial and can improve disease management, diagnosis, and therapy. [34, 35] Our results suggest that psychotherapy should be introduced as standard care for patients with cancer. In many countries psychologist are not part of the patient care team and psychotherapy is not available for oncological patients. To achieve the best possible results, psychological interventions should be provided especially in the early stages of cancer and should be repeated at least three or four times to maintain the beneficial effects. Further trials could make more personalized recommendations based on cancer types and stages and different psychological methods.

Another important aspect of this review is that our results highlight the need for randomized-controlled clinical trials with standardized methods and reporting on results to assess the effect of psychological interventions accurately. Psychological research is always a challenge; however, more objective analyses could be obtained by standardizing intervention methods, questionnaires, intervention duration, frequency, and the way data and results are reported.

Acknowledgments

None to declare.

Author’s contribution

ASB helped in conceptualization, project administration, and writing original drafts. BT and SB contributed to conceptualization, data curation, methodology, writing original drafts, review, and editing. DSV and BSz helped in conceptualization and formal analysis and review and editing. BF, NV, OA, YH and DG helped in conceptualization and data curation. BE, EM contributed to conceptualization and review, and editing.

KM helped with the conceptualization, supervision, writing of the original draft, and review and editing. PH helped in conceptualization, funding acquisition, writing of the original draft– review, and editing.

All authors provided critical conceptual input and approved the final version of the article.

Data availability statement

All data is shared as additional file.

Competing interest statement

None to declare.

Funding

Funding was provided by the New National Excellence Program of the Ministry for Innovation and Technology from the source of the National Research, Development and Innovation Fund (to BT – ÚNKP-22-3-I-PTE-1693 and to KM – ÚNKP-22-4-II) and by an ITM NRDIF grant (TKP2021-EGA-23).

Sponsors had no role in the design, data collection, analysis, interpretation, and manuscript preparation.

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No competing interests reported.

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Psychological Intervention Improves Quality of Life, but Not Survival in Patients with Early-Stage Cancer: a Systematic Review and Meta-analysis of randomized clinical trials

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INTRODUCTION

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