Systematic screening and assessment of psychosocial well‐being and care needs of people with cancer Edited (no change to conclusions)

Abstract

Abstract Background

Receiving a diagnosis of cancer and the subsequent related treatments can have a significant impact on an individual's physical and psychosocial well‐being. To ensure that cancer care addresses all aspects of well‐being, systematic screening for distress and supportive care needs is recommended. Appropriate screening could help support the integration of psychosocial approaches in daily routines in order to achieve holistic cancer care and ensure that the specific care needs of people with cancer are met and that the organisation of such care is optimised.

Objectives

To examine the effectiveness and safety of screening of psychosocial well‐being and care needs of people with cancer. To explore the intervention characteristics that contribute to the effectiveness of these screening interventions.

Search methods

We searched five electronic databases in January 2018: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, and CINAHL. We also searched five trial registers and screened the contents of relevant journals, citations, and references to find published and unpublished trials.

Selection criteria

We included randomised controlled trials (RCTs) and non‐randomised controlled trials (NRCTs) that studied the effect of screening interventions addressing the psychosocial well‐being and care needs of people with cancer compared to usual care. These screening interventions could involve self‐reporting of people with a patient‐reported outcome measures (PROMs) or a semi‐structured interview with a screening interventionist, and comprise a solitary screening intervention or screening with guided actions. We excluded studies that evaluated screening integrated as an element in more complex interventions (e.g. therapy, coaching, full care pathways, or care programmes).

Data collection and analysis

Two review authors independently extracted the data and assessed methodological quality for each included study using the Cochrane tool for RCTs and the Risk Of Bias In Non‐randomised Studies ‐ of Interventions (ROBINS‐I) tool for NRCTs. Due to the high level of heterogeneity in the included studies, only three were included in meta‐analysis. Results of the remaining 23 studies were analysed narratively.

Main results

We included 26 studies (18 RCTs and 8 NRCTs) with sample sizes of 41 to 1012 participants, involving a total of 7654 adults with cancer. Two studies included only men or women; all other studies included both sexes. For most studies people with breast, lung, head and neck, colorectal, prostate cancer, or several of these diagnoses were included; some studies included people with a broader range of cancer diagnosis. Ten studies focused on a solitary screening intervention, while the remaining 16 studies evaluated a screening intervention combined with guided actions. A broad range of intervention instruments was used, and were described by study authors as a screening of health‐related quality of life (HRQoL), distress screening, needs assessment, or assessment of biopsychosocial symptoms or overall well‐being. In 13 studies, the screening was a self‐reported questionnaire, while in the remaining 13 studies an interventionist conducted the screening by interview or paper‐pencil assessment. The interventional screenings in the studies were applied 1 to 12 times, without follow‐up or from 4 weeks to 18 months after the first interventional screening. We assessed risk of bias as high for eight RCTs, low for five RCTs, and unclear for the five remaining RCTs. There were further concerns about the NRCTs (1 = critical risk study; 6 = serious risk studies; 1 = risk unclear).

Due to considerable heterogeneity in several intervention and study characteristics, we have reported the results narratively for the majority of the evidence.

In the narrative synthesis of all included studies, we found very low‐certainty evidence for the effect of screening on HRQoL (20 studies). Of these studies, eight found beneficial effects of screening for several subdomains of HRQoL, and 10 found no effects of screening. One study found adverse effects, and the last study did not report quantitative results. We found very low‐certainty evidence for the effect of screening on distress (16 studies). Of these studies, two found beneficial effects of screening, and 14 found no effects of screening. We judged the overall certainty of the evidence for the effect of screening on HRQoL to be very low. We found very low‐certainty evidence for the effect of screening on care needs (seven studies). Of these studies, three found beneficial effects of screening for several subdomains of care needs, and two found no effects of screening. One study found adverse effects, and the last study did not report quantitative results. We judged the overall level of evidence for the effect of screening on HRQoL to be very low. None of the studies specifically evaluated or reported adverse effects of screening. However, three studies reported unfavourable effects of screening, including lower QoL, more unmet needs, and lower satisfaction.

Three studies could be included in a meta‐analysis. The meta‐analysis revealed no beneficial effect of the screening intervention on people with cancer HRQoL (mean difference (MD) 1.65, 95% confidence interval (CI) −4.83 to 8.12, 2 RCTs, 6 months follow‐up); distress (MD 0.0, 95% CI −0.36 to 0.36, 1 RCT, 3 months follow‐up); or care needs (MD 2.32, 95% CI −7.49 to 12.14, 2 RCTs, 3 months follow‐up). However, these studies all evaluated one specific screening intervention (CONNECT) in people with colorectal cancer.

In the studies where some effects could be identified, no recurring relationships were found between intervention characteristics and the effectiveness of screening interventions.

Authors' conclusions

We found low‐certainty evidence that does not support the effectiveness of screening of psychosocial well‐being and care needs in people with cancer. Studies were heterogeneous in population, intervention, and outcome assessment.

The results of this review suggest a need for more uniformity in outcomes and reporting; for the use of intervention description guidelines; for further improvement of methodological certainty in studies and for combining subjective patient‐reported outcomes with objective outcomes.

Author(s)

Bojoura Schouten, Bert Avau, Geertruida (Trudy) E Bekkering, Patrick Vankrunkelsven, Jeroen Mebis, Johan Hellings, Ann Van Hecke

Abstract

Plain language summary

Systematic screening and assessment of psychosocial well‐being and care needs of people with cancer

Background
 People with cancer may experience physical, psychological, and social problems due to the disease and its treatment. It is therefore important to take into account all of these aspects during the diagnosis and treatment of people with cancer. Nowadays, screening for psychosocial well‐being and care needs is often recommended. This means that patients are systematically queried about their well‐being and needs related to several psychosocial aspects (e.g. cognitive functioning, emotions, relationships and communication with loved ones, sexuality, social participation, employment). This is applied with self‐report questionnaires, or interviews in which the content of these questionnaires or checklists is used as interview guide. The current review had two objectives: to examine the effects and possible harms of screening of psychosocial well‐being and care needs of people with cancer, and to examine which characteristics of screening are more or less effective.

Study characteristics
 We found 26 studies including a total of 7654 adults with cancer. Most studies included both males and females. With regard to cancer type, most studies included people with a specific type of cancer, but some included a variety of cancer types. Furthermore, the type of screening differed: half of the studies asked participants to self‐complete a screening questionnaire about their psychosocial health, while in the remaining studies screening interviews were conducted in which a healthcare professional questioned participants about their well‐being face‐to‐face.

Key results
 Several studies showed benefits of screening on psychosocial well‐being of cancer patients, such as their health‐related quality of life, distress, care needs, and patient satisfaction. However, some studies also found negative effects. There were important differences between the studies: they assessed different psychosocial aspects (e.g. health‐related quality of life, distress, care needs, and patient satisfaction) and differed in their modes of screening (i.e. self‐report screening questionnaire versus screening interview), timing and frequency of the screening (1 to 12 times), outcome measures, and outcome time points. Due to these differences, only three studies studying the same intervention could be included in the analysis.

Certainty of the evidence
 Our results do not support the screening of psychosocial well‐being and care needs in people with cancer. The certainty of the evidence was low, which means that we are uncertain about the results of the review due to variations in characteristics, and results of the studies and study designs.

Author(s)

Bojoura Schouten, Bert Avau, Geertruida (Trudy) E Bekkering, Patrick Vankrunkelsven, Jeroen Mebis, Johan Hellings, Ann Van Hecke

Reviewer's Conclusions

Authors' conclusions

Implications for practice

During the last decade several calls have been launched to stimulate the design of psychosocial screening programs in clinical practice, and, to support this, consensus‐based guidelines have been written (Carlson 2012; Howell 2012; Lowery 2012; Luckett 2009). With these guidelines, one aimed at answering several questions from clinical practice: ‘What should be the exact content of the screening?’ ‘Which tools should be used?’ ‘What are the appropriate timing and frequency of assessments?' ‘Who should conduct these interventions?’. With this review, we not only attempted to explore the effect of the interventions, but additionally set the objective to add evidence‐based input to the earlier formulated consensus‐based recommendations on intervention characteristics which showed consistency with the effectiveness of the screening interventions.

Some of the included studies suggested some benefits of systematic screening (for health‐related quality of life, quality of life, distress, care needs, patients’ satisfaction, and/or psychosocial well‐being). However, based on the results of this review, screening of the psychosocial well‐being and care needs of people with cancer in general does not seem to be meaningful for the well‐being of these individuals. Attention should possibly be paid to more specific forms of screening in high‐risk populations, or in specific healthcare disciplines. Likewise, we did not find any systematic patterns of cohesion between individual study effects and intervention characteristics. On the basis of the evidence found, it is therefore difficult to say which intervention elements and characteristics should be used in the development of these interventions. Further research is needed to support the guidelines and recommendations for clinical practice with evidence‐based data.

Implications for research

The results of this review plea for more uniformity in outcomes and reporting; the use of intervention description guidelines; further improvement of methodological certainty in studies; and combining subjective patient‐reported outcomes with objective outcomes.

We advise researchers to use validated, internationally recognised tools such as the European Organisation for Research and Treatment of Cancer‐Quality of Life Questionnaire‐Core 30 (EORTC QLQ‐C30), 36‐item Short Form Health Survey (SF‐36), Functional Assessment of Cancer Therapy‐General (FACT‐G), General Health Questionnaire 12‐item version (GHQ‐12), Hospital Anxiety and Depression Scale (HADS), Distress Thermometer (DT), Supportive Care Needs Survey (SCNS), and Patient Satisfaction Questionnaire (PSQ) to measure patients’ psychosocial well‐being, care needs, and satisfaction. There has been pleading in recent years for the development of core outcome sets. Core outcome sets are agreed standardised collections of outcomes that should be measured and reported in all trials within a specific field of research (Williamson 2012). The development and use of core outcome sets could reduce heterogeneity in outcomes.

In addition, it is important that study authors clearly describe the intervention content, tools, procedure, and conditions for implementation, so that other researchers can construct and study comparable interventions in other patient populations. This way homogeneity can be pursued, and meta‐analyses could be possible in the future. For example, the Template for Intervention Description and Replication (TIDieR) and the Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2) guidelines were developed to support this purpose (Hoffmann 2014; Mohler 2015).

Although improvement is already being seen, we believe that further efforts should be made to improve the methodological quality of studies, to reduce the risk of bias, and to obtain more reliable and less ambiguous evidence. This review provides several points of attention for this purpose. We believe that well‐developed RCTs as well as NRCTs can have a valuable role in future research on the effectiveness of screening and assessment of psychosocial well‐being and care needs in people with cancer.

When more homogeneity in intervention characteristics can be achieved in combination with an improvement of methodological quality, it will be possible to explore the intervention characteristics that contribute to the effectiveness of these screening interventions.

Finally, we recommend that future studies include the subjective patient‐reported outcome measures together with more objective outcomes, such as biomedical indicators of distress, or care outcomes to detect possible effects in care processes. The latter are less prone to response bias, and care outcomes have shown promising results in several studies (Bramsen 2008; Detmar 2002; Hilarius 2008; Maunsell 1996; Taenzer 2000). At the same time, the use of patient‐reported outcome measures ensures that insights from the patient perspective are obtained, which is of great importance to support the patient‐centred approach in care and research (Boyce 2014).

The evidence from studies conducted so far is not conclusive on the effect of the studied intervention, but suggests the absence of a general intervention effect. We think that future studies in this field should focus on patients in populations at high risk of experiencing increased levels of distress and care needs (e.g. younger, single, female, worse clinical status, lower quality of life, lower socioeconomic status). Focusing on high‐risk patients could permit a determination as to whether screening interventions may have an effect in vulnerable subgroups.

Furthermore, we wonder why some of the interventions in the included studies resulted in negative effects on individuals' health‐related quality of life, care needs, and satisfaction. No explanation for these effects could be found in the intervention characteristics. We may hypothesise that the intervention makes some people more dependent, resulting in an increased expression of problems and care needs. In future studies, more attention needs to be paid to the 'how' and 'why' of negative intervention effects should they occur.

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