Psychosocial interventions for fatigue during cancer treatment with palliative intent Stable (no update expected for reasons given in 'What's new')

Abstract

Abstract Background

Fatigue is a prevalent and burdensome symptom for patients with incurable cancer receiving cancer treatment with palliative intent and is associated with reduced quality of life. Psychosocial interventions seem promising for management of fatigue among cancer patients.

Objectives

To assess the effects of psychosocial interventions for fatigue in adult patients with incurable cancer receiving cancer treatment with palliative intent.

Search methods

We searched the following databases: CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, and seven clinical trial registries; we also searched the reference lists of articles. The date of our most recent search was 29 November 2016.

Selection criteria

We included randomised controlled trials that compared psychosocial interventions in adults aged 18 years or over undergoing cancer treatment with palliative intent for incurable cancer versus usual care or other controls. Psychosocial interventions were defined as various kinds of interventions provided to influence or change cognitions, emotions, behaviours, social interactions, or a combination of these. Psychosocial interventions of interest to this review had to involve at least two interactions between the patient and the care provider in which the care provider gave the patient personal feedback concerning changes sought by these interventions. We included trials that reported fatigue as an outcome of interest.

Data collection and analysis

We used standard methodological procedures expected by Cochrane. Two review authors independently considered trials for inclusion in the review, assessed risk of bias, and extracted data, including information on adverse events. We assessed the quality of evidence using GRADE (Grading of Recommendations Assessment, Development, and Evaluation) and created a 'Summary of findings’ table.

Main results

We identified 14 studies (16 reports) that met inclusion criteria for this review and involved 3077 randomised participants in total. Most of these studies included a mixed sample of participants; we obtained data for the subset of interest for this review (diagnosis of incurable cancer and receiving cancer treatment) from the study investigators of 12 studies, for which we included 535 participants in the subset meta‐analysis for fatigue post intervention. Researchers investigated a broad range of psychosocial interventions with different intervention aims and durations. We identified sources of potential bias, including lack of description of methods of blinding and allocation concealment and inclusion of small study populations.

Findings from our meta‐analysis do not support the effectiveness of psychosocial interventions for reducing fatigue post intervention (standardised mean difference (SMD) ‐0.25, 95% confidence interval (CI) ‐0.50 to 0.00; not significant; 535 participants, 12 studies; very low‐quality evidence). First follow‐up findings on fatigue suggested benefit for participants assigned to the psychosocial intervention compared with control (SMD ‐0.66, 95% CI ‐1.00 to ‐0.32; 147 participants, four studies; very low‐quality evidence), which was not sustained at second follow‐up (SMD ‐0.41, 95% CI ‐1.12 to 0.30; not significant; very low‐quality evidence).

Results for our secondary outcomes revealed very low‐quality evidence for the efficacy of psychosocial interventions in improving physical functioning post intervention (SMD 0.32, 95% CI 0.01 to 0.63; 307 participants, seven studies). These findings were not sustained at first follow‐up (SMD 0.37, 95% CI ‐0.20 to 0.94; not significant; 122 participants, two studies; very low‐quality evidence). Findings do not support the effectiveness of psychosocial interventions for improving social functioning (mean difference (MD) 4.16, 95% CI ‐11.20 to 19.53; not significant; 141 participants, four studies), role functioning (MD 3.49, 95% CI ‐12.78 to 19.76; not significant; 143 participants, four studies), emotional functioning (SMD ‐0.11, 95% CI ‐0.56 to 0.35; not significant; 115 participants, three studies), or cognitive functioning (MD ‐2.23, 95% CI ‐12.52 to 8.06; not significant; 86 participants, two studies) post intervention. Only three studies evaluated adverse events. These studies found no difference between the number of adverse events among participants in the intervention versus control group.

Using GRADE, we considered the overall quality of evidence for our primary and secondary outcomes to be very low. Therefore, we have very little confidence in the effect estimate, and the true effect is likely to be substantially different from the estimate of effect. Limitations in study quality and imprecision due to sparse data resulted in downgrading of the quality of data. Additionally, most studies were at high risk of bias owing to their small sample size for the subset of patients with incurable cancer (fewer than 50 participants per arm), leading to uncertainty about effect estimates.

Authors' conclusions

We found little evidence around the benefits of psychosocial interventions provided to reduce fatigue in adult patients with incurable cancer receiving cancer treatment with palliative intent. Additional studies with larger samples are required to assess whether psychosocial interventions are beneficial for addressing fatigue in patients with incurable cancer.

Author(s)

Hanneke Poort, Marlies Peters, Gijs Bleijenberg, Marieke FM Gielissen, Martine Margaretha Goedendorp, Paul Jacobsen, Stans Verhagen, Hans Knoop

Abstract

Plain language summary

Psychological therapies to reduce tiredness in patients with incurable cancer

Background

Patients with incurable cancer often experience tiredness (fatigue) during cancer treatment. Psychological therapies may help to reduce this symptom. Tiredness in cancer patients receiving cancer treatment may be treated with psychological therapies aimed at influencing or changing thoughts, emotions, behaviours, social interactions, or a combination of these (e.g. cognitive‐behavioural therapies, supportive‐expressive group therapies). This review looked at how effective psychological therapies are in reducing tiredness in patients with incurable cancer receiving cancer treatment.

Study characteristics

In November 2016, we searched for clinical trials looking at psychological therapies in patients with incurable cancer receiving cancer treatment. We found 14 small studies of very low quality reporting data on tiredness outcomes, 12 of which provided data for analyses. A limited number (three studies) reported results about side effects; these studies investigated a psychological therapy combined with medication.

Key findings

Review authors found no support for the effectiveness of psychological therapies in reducing tiredness when assessed directly following the intervention. Very low‐quality evidence suggests that psychological therapies may improve physical functioning directly after the intervention and may improve tiredness at first follow‐up. Evidence shows no support for the effectiveness of psychosocial therapies in improving other domains of functioning. Limited evaluation of potential harm suggests no differences in side effects between patients receiving psychological therapy and those given usual care. Limited good quality evidence allows no conclusions on the use of psychological therapies in people with incurable cancer. Larger, high‐quality trials are needed to find out whether psychological therapies help reduce tiredness for people with incurable cancer during cancer treatment.

Quality of the evidence

We rated the quality of study evidence using four levels: very low, low, moderate, and high. Very low‐quality evidence means that we are very uncertain about the results. High‐quality evidence means that we are very confident in the results. Included studies had design problems and included a very small number of participants. Therefore, the quality of the evidence in this review is very low, and results of this review should be interpreted with caution.

Author(s)

Hanneke Poort, Marlies Peters, Gijs Bleijenberg, Marieke FM Gielissen, Martine Margaretha Goedendorp, Paul Jacobsen, Stans Verhagen, Hans Knoop

Reviewer's Conclusions

Authors' conclusions

Implications for practice

This review found insufficient evidence showing the effectiveness of psychosocial interventions used to treat fatigue in patients with incurable cancer receiving treatment with palliative intent. Therefore, specific implications for patients with incurable cancer, for clinicians, for policy makers, or for funders of the interventions cannot be given.

Implications for research Evidence

Further evidence is needed from high‐quality trials with large samples that fully report methodological characteristics and potential harms. We identified two ongoing studies that aim to enrol 240 participants (Serfaty) and 219 participants (Poort) with a diagnosis of incurable cancer. With large samples, both studies have the potential to provide substantial assistance to those seeking answers to the research question that is the topic of this review.

Population

Additional studies with a homogeneous study sample of patients with incurable cancer are needed. Targeting patients most in need (i.e. those reporting clinically significant levels of fatigue) to eliminate potential floor effects has been recommended before (Bower 2014) and would be a helpful approach in future studies. Also, future studies should expand the focus beyond patients with metastatic breast cancer, as it is unknown whether findings from this patient group can be generalised to patients with other cancer diagnoses. Therefore, enriching the evidence with studies that focus on patients diagnosed with other types of incurable cancer would be helpful. Moreover, future studies should include a substantial proportion of male participants and should determine whether gender moderates treatment outcomes, as most of the participants in studies conducted thus far have been females. Finally, given the difficulty of recruiting large enough samples in palliative care trials, multi‐centre studies are recommended, as studies with larger patient samples may detect small but clinically relevant differences. Alternatively, application of novel research designs (e.g. replicated n‐of‐1 trials) might be worthwhile given the difficulties involved in conducting randomised controlled trials (RCTs) of patients receiving cancer treatment with palliative intent.

Intervention

Psychosocial interventions are part of a broader portfolio of available interventions for cancer‐related fatigue, which includes interventions focused on physical activity and pharmacological approaches. For future research aimed at psychosocial interventions, we recommend that protocols for a trial, including a detailed description of the intervention and its components, should be published or otherwise made publicly available. Also, tailoring the content of interventions to patients with incurable cancer would be helpful, given the substantial difference in prognosis between patients with potentially curable and incurable cancer. This difference has implications for the psychosocial factors thought to maintain fatigue and addressed by the interventions. Moreover, we would recommend short interventions delivered over a period of several weeks or months, with follow‐up assessments following shortly (within three to eight months) after intervention delivery. This is recommended not only to prevent participant attrition (which complicates interpretation of findings) as much as possible, but also to minimise the burden of participation.

Comparison

Given the current state of the evidence, we recommend that researchers conducting future trials should compare psychosocial interventions versus usual care or attentional controls.

Outcome

No consensus has been reached on which instruments should be used to measure fatigue and it would be helpful to reduce the variance among outcome instruments used to measure reduction in fatigue. Future studies should clearly assess benefits and potential adverse events (e.g. increased psychological distress) of the intervention.

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