Von Ah 2012.
Study characteristics | ||
Methods | Randomised controlled trial Intention‐to‐treat analysis: ITT was not undertaken Loss to follow‐up: numbers and reasons reported in flowchart |
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Participants |
Inclusion criteria Females aged 40 years and over diagnosed with breast cancer, currently disease‐free, post‐menopausal, able to read, write and understand English who at least one‐year post‐treatment with a history of chemotherapy receipt for non‐metastatic breast cancer, reporting cognitive impairment post‐treatment which negatively impacted their daily lives. Exclusion criteria Substantial cognitive impairment (MMSE < 24), history of cranial radiation or intrathecal therapy, stroke, encephalitis, traumatic brain injury, brain surgery, Alzheimer's disease or Parkinson's disease, current active major depression, substance abuse, history of bipolar disorder, psychosis, schizophrenia or learning disability, history of, or current other cancer (with the exception of basal cell skin cancer) or uncorrected vision problems. Participants were sequentially recruited from Midwestern Cancer Centre and affiliated clinics and advertisements were posted to research registry participants. Participants: 88 (I1: 29/ I2: 30/ C: 29) Cancer site(s): Breast 89% of total sample were stage II and under. Age: I1: mean = 55.19 (SD = 7.58); I2: 56.93 (SD = 7.83); C: mean = 57.21 (SD = 9.80) Sex: Female Treatment history: All participants received chemotherapy and surgery and 74% of participants also received radiotherapy. Co‐morbidities: None reported Education: I1: mean = 15.96 years (SD = 1.87); I2: mean = 15.63 years (SD = 2.50); C: mean = 15.43 (SD=2.27) Socio‐economic status: None reported Cognitive impairment at baseline: Participants had to report cognitive impairment and its impact on daily life Country: USA |
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Interventions |
Intervention one Definition: Memory Training (adapted from the Advanced Cognitive Training for Independent and Vital Elderly) To assess the acceptability/satisfaction and efficacy of memory training on improving cognitive function Components: Sessions 1‐5: Instruction and strategies to practice techniques for remembering (including multiple mnemonic techniques). Sessions 6‐10 provided additional practice exercises to promote self‐efficacy with regards to performance. Techniques: Social support (unspecified): group setting for delivery of intervention Instruction on how to perform the behaviour: teaching and instruction of compensatory strategies Demonstration of the behaviour: teaching and instruction of compensatory strategies Behavioural practice/rehearsal: strategy practice exercises Materials: none reported Theoretical basis/mechanism: none reported Duration: 10 one‐hour sessions over a 6‐8 week period Setting: Group‐based setting with 3‐5 participants in each Personnel: Trained interventionists Comparison: Wait‐list control Intervention two Definition: Speed of processing training (commercially available computer‐based 'Insight' program from Posit Science) To assess the acceptability/satisfaction and efficacy of speed of processing training on improving cognitive function Components: Progressively difficult information‐processing tasks whereby stimulus duration is systematically reduced. Techniques Feedback on behaviour: programme gives feedback in terms of performance Feedback on outcome(s) of behaviour: programme gives feedback in terms of performance Social support (unspecified): intervention delivered in group setting Behavioural practice/rehearsal: practice exercises Graded tasks: increasingly difficult exercises Materials: None reported Theoretical basis/mechanism: None reported Duration: 10 one‐hour sessions over a 6‐ to 8‐week period Setting: Group‐based setting with 3 to 5 participants in each Personnel: Trained interventionists Comparison: Wait‐list control |
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Outcomes | Outcomes assessed at baseline, post‐intervention and 2‐month post‐intervention Subjective cognitive function: FACT‐Cog (version 2) and Squire Subjective Memory Questionnaire Objective cognitive function: *Composite score of RAVLT (sum recall (trials 1‐5), short delay, recognition score) and *Rivermead Behavioural Paragraph Recall Test (RBPRT) (immediate recall) to measure immediate memory recall; composite score of RAVLT (long‐term delay score) and RBPRT (long‐term delay score) to assess delayed recall; composite score of Useful Field of View (3 subtests) to measure speed of processing. Secondary outcomes: SF‐36 (physical and mental component summary scores), QOL‐ CS and QLI‐C to assess QoL; FACT‐F to assess fatigue; CES‐D to assess depression; STAI to assess anxiety; acceptability using a study‐specific scale and Client Satisfaction Questionnaire to measure satisfaction with intervention. Adherence: Completion rates Safety issues: None reported. Adverse effects: None reported. |
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Notes | *Primary outcomes measured in study. Participants received $25 for each data collection visit. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Subjects were randomized using non‐stratified blocks of 9." Pg 800 |
Allocation concealment (selection bias) | Low risk | "Biostatisticians provided a password protected randomization list to the non‐blinded project manager who had primary responsibility for randomization. Participants were notified by telephone of group assignment and intervention dates." Pg 800 |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "Participants were notified of group allocation and intervention dates"' Pg 800 It is not possible to blind participants from group allocation. "...single‐blind study.." Pg 800 "Each intervention...delivered by separate trained and certified interventionists to avoid diffusion of treatments." Pg 800 "...non‐blinded project manager who had responsibility for randomization." Pg 800 |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | "...neuropsychological testing and questionnaires collected by a trained and blinded staff member." Pg. 800 |
Incomplete outcome data (attrition bias) All outcomes | High risk | All participants accounted for and reasons reported. Pg 803 Missing data were not imputed and intention‐to‐treat analysis was not undertaken. |
Selective reporting (reporting bias) | Unclear risk | Authors created composite objective cognition scores from a number of individual measures; means and SDs on individual measures and composite scores are not reported at both follow‐ups, although, reliable improvement and net effect sizes are reported. |
Baseline imbalances in cognition scores Objective outcomes | Low risk | "There were no significant group differences at baseline in...cognitive abilities (immediate and delayed memory and processing speed)." Pg 802 |
Baseline imbalances in cognition scores Subjective outcomes | Unclear risk | No mention of subjective cognitive outcomes when describing baseline group differences. |
Validity of cognitive function measures Objective outcomes | Unclear risk | None reported. |
Validity of cognitive function measures Subjective outcomes | Unclear risk | None reported. |
Reliability of cognitive function measures Objective outcomes | Unclear risk | None reported. |
Reliability of cognitive function measures Subjective outcomes | Unclear risk | None reported. |
Abbreviations: BC = Breast cancer; BRIEF = Behavioral Rating Inventory of Executive Functioning;BFI = Brief Fatigue Inventory; CAD = Clinical Assessment of Depression; CBT = Cognitive behavioural therapy; CD = Compact Disc; CNS = Central Nervous System; CES‐D = Centre for Epidemiological Studies‐ Depression scale; C = control; COWAT = Controlled Oral Word Association Test; CVLT = California Verbal Learning Test‐II; D‐KEFS = Delis‐Kaplan Executive Function System; DSM IV = Diagnostic Statistical Manual (version IV); FACT‐Cog = Functional Assessment of Cancer Therapy‐ Cognition subscale; FACT‐F = Functional Assessment of Cancer Therapy‐Fatigue subscale; FACT‐Spiritual = Functional Assessment of Cancer Therapy‐Spiritual subscale;fMRI = functional Magnetic Resonance Imaging; HVLT‐R= Hopkin's Verbal Learning Test‐ Revised; ITT = Intention‐to‐treat; I = intervention; MMSE = Mini‐Mental Status Examination; MASQ = Multiple Ability Self‐report Questionnaire; PQSI = Pittsburgh Sleep Quality Index; QLI‐C = Quality of life index‐ cancer version;QoL = Quality of Life; QOL‐CS = Quality of life‐ Cancer Survivor; RAVLT = Rey Auditory Verbal Learning Trial; SD = Standard Deviation; SF‐36 = Short Form Health Survey‐ 36 item; STAI = State Trait Anxiety Index; VO2 = Volume oxygen; WLC = wait‐list control; WAIS‐III = Wechsler Adult Intelligence‐III; WCST = Wisconsin Card Sorting Test