Types of studies

Studies will be included if they are RCTs of interventions. Quasi‐randomised trials and crossover trials will be excluded. No language restrictions will be applied. 

Types of participants

Studies involving adults 18 years and older will be included regardless of gender, tumour stage, tumour type, and type of treatment. Participants may be receiving curative or palliative treatment, be receiving long‐term follow up, or have no evidence of active disease.

Types of interventions

To be included studies must state that they aim to evaluate the effect of educational interventions designed specifically to manage CRF, or educational interventions targeting a constellation of physical symptoms or quality of life where fatigue is the primary focus. Educational interventions are defined here as any advice or information (verbal, written, audiovisual or computer delivered material) given in order to help people understand and manage CRF. Studies of interventions will be included if they provide information and advice about non‐pharmacological strategies (e.g. information about relaxation, information about CBT strategies, or information about energy conservation), but will be excluded if these strategies are actually delivered. Interventions do not need to be delivered face to face but may include interventions delivered via telephone, post or the Internet.

Studies that use psycho‐behavioural methods such as meditation, relaxation or techniques to improve coping with fatigue will not be included, unless a comparative treatment arm of education only is used. Studies that combine psycho‐behavioural methods with education will be excluded to minimise confounding unless a comparative treatment arm of education only is used. The intervention may take place in any setting, be delivered either to a group or an individual and may involve a single education session or a series of sessions.

Types of outcome measures

Outcome measures of fatigue will be via self‐report as fatigue is a subjectively experienced symptom. Self‐report of fatigue may be measured through questionnaires or diaries.

Electronic searches

We will search the Cochrane Central Register of Controlled Trials (CENTRAL), The PaPaS review group's specialized register, MEDLINE, EMBASE, CINAHL PsycINFO, Dissertation Abstracts International, LILACS, ERIC, OTseeker, PEDro and CancerLit.

We will use search strategies based on the MEDLINE (via OVID) strategy set out in Appendix 1. We will use the Cochrane Collaboration filter for the identification of RCTs, as published in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2008). The search strategy will be adjusted for each database searched and will only select non‐English language studies if they have an abstract published in English.

Searching other resources

In an effort to identify further published, unpublished and ongoing trials we will:

1. check reference lists of all relevant studies;

2. search ongoing trials and research registers including ClinicalTrials.gov (www.clinicaltrials.gov/), the National Research Register (www.nrr.nhs.uk/search.htm), and the Australian New Zealand Clinical Trials Registry;

3. contact investigators known to be involved in research in this area;

4. search Science Citation Index using the cited reference search;

5. hand search relevant journals we have access to that are not available electronically that have not been searched on behalf of The Cochrane Collaboration;

6. check published abstracts through searches of conference proceedings and obtain full trial data if possible either from the abstract or by contacting the authors.

Selection of studies

One review author (SB) will initially screen titles and abstracts and eliminate those obviously not relevant to this review. Two review authors (SB and PM) will independently screen the remaining titles and abstracts for their eligibility for inclusion in accordance with the above defined criteria. When the title and abstract do not provide all the information concerning the criteria, full paper copies will be retrieved and screened. Non‐English language articles that have an English abstract and are deemed potentially eligible will be translated to determine final eligibility. We will retrieve full text copies of all studies if either review author determines that the study possibly or definitely meets the inclusion criteria. For a trial to be included it must include fatigue as a primary outcome measure and one treatment arm must be an educational intervention with the primary aim being management of fatigue.

1. Include if all of the following are met:

   1. RCT,

   2. a primary aim of the study was to evaluate the effect of educational interventions to manage CRF,

   3. participants 18 years or older,

   4. diagnosed with cancer,

   5. at least one of the study arms received an information‐only educational intervention designed specifically to manage CRF, or an information‐only educational intervention targeting a constellation of physical symptoms or quality of life where fatigue is the primary focus, and

   6. the primary outcome of interest includes the measurement of fatigue or loss of energy.

2. Possible/unclear: appears to fit the inclusion criteria but there is insufficient information available to be certain, review of the methods necessary to verify inclusion.

3. Exclude: definitely not a RCT; or participants not 18 years or older; or were not diagnosed with cancer, or did not receive an educational intervention, or did not have fatigue or loss of energy as a primary outcome.

Study authors will be contacted where information is unclear. Disagreement about the selection of a study will be resolved by consensus; if necessary a third review author (AP or JF) will be consulted to reach a final decision.

Data extraction and management

Two review authors (SB and AP) will independently extract data from the studies using a standard data extraction form. Authors will be contacted in order to obtain any missing data. Data will include:

Assessment of risk of bias in included studies

Two review authors (SB and AP) will independently assess the risk of bias of the selected studies using the Cochrane risk of bias tool. A third review author (TH) will provide consensus assessment where agreement cannot be achieved with discussion between the two review authors. Authors will be contacted for clarification of methods used if required.

Measures of treatment effect

We will use The Cochrane Collaboration's Review Manager software, RevMan 5, for all analyses. For each comparison, the outcomes will be recorded both at the end of the intervention period and at the end of the scheduled follow up. We will calculate the mean difference and the 95% confidence interval (CI) for continuous data. For continuous outcomes where no standard deviations are reported, we will calculate the standard deviation using the methods described in the Cochrane Handbook for Systematic Reviews of Interventions. We will calculate the standardised mean difference and the 95% CI for continuous data that will pooled and measure the same outcome using different measurement tools as per the plan for data synthesis described below. We will calculate the relative risks (RRs) and 95% CI for dichotomous data and the number needed to treat (NNT) will be estimated from the trials providing appropriate data.

Unit of analysis issues

Unit of analysis will be the participants.

Dealing with missing data

Data for all participants will be analysed in the group to which they are allocated, regardless of whether or not they received the allocated intervention. If in the original reports participants are not analysed in the group to which they were randomised, and there is sufficient information in the study report, we will attempt to restore them to the correct group. Where data are missing, whenever possible clarification will be sought from the authors.

Assessment of heterogeneity

The studies were first assessed for clinical homogeneity with respect to the population, intervention, and outcomes. For studies judged to be clinically heterogeneous we plan to describe them separately and not combine them in a meta‐analysis. Studies without substantial clinical heterogeneity will be tested for statistical heterogeneity using the I‐squared (I²)statistic (I² greater than 50% is considered substantial heterogeneity). If heterogeneity is suspected, we will explore and present possible causes and the possibility of utilising a random‐effects model of meta‐analysis will be considered.

Assessment of reporting biases

Where we suspect reporting bias, we will attempt to contact study authors asking them to provide missing outcome data. Where this is not possible, and the missing data are thought to introduce serious bias, the impact of including such studies in the overall assessment of results will be explored by a sensitivity analysis. 

Data synthesis

We plan to pool clinically and statistically homogeneous studies using the fixed‐effect model, and clinically homogeneous and statistically heterogeneous studies using the random‐effects model. Continuous data will be combined only where (i) means and standard deviations are available or calculable and (ii) there is no clear evidence of skew in the distribution (using methods described in the Cochrane Handbook for Systematic Reviews of Interventions). When able to be combined, mean difference of scales measuring the same clinical outcomes in different ways will be standardised in order to combine results across scales, otherwise weighted mean differences will be used.

Subgroup analysis and investigation of heterogeneity

If sufficient data are available, we will undertake subgroup analysis based on tumour type, tumour stage, treatment type, group versus individual intervention, and timing of intervention relative to treatment (e.g. intervention during treatment or intervention delivered while not receiving treatment). Subgroup analysis will be completed using the Deeks method (Deeks 2001). We will restrict analyses to looking at effects of the primary outcome (fatigue).

Sensitivity analysis

Sensitivity analysis will be carried out, where appropriate, to explore the effects of risk of bias. Studies of greater risk of bias quality, as assessed by concealment of allocation will be excluded in the analysis in order to assess for any substantive difference to the overall result. If no substantive difference exists, the studies will be left in for the main analysis. For concealment of allocation, studies with clearly inadequate allocation of concealment (rated inadequate) will be excluded. This sensitivity analysis will be conducted for the primary outcomes only.