Ferguson 2012.
Study characteristics | ||
Methods | Randomised controlled trial Intention‐to‐treat analysis: ITT was undertaken using linear interpolation methods used to infer missing data to maintain power for the analysis. Lost to follow‐up: numbers reported in flowchart and reasons reported in text. |
|
Participants |
Inclusion criteria Females at least 18 years of age diagnosed with stages I‐II breast cancer, at least 18 months post‐treatment and currently disease‐free with previous chemotherapy receipt with self‐reported problems with memory or attention following chemotherapy and who were able to speak and read English. Exclusion criteria Current psychiatric disorder, neuro‐behavioural risk factors, history of CNS disease or receipt of treatment for CNS cancer. Participants were recruited via newspaper advertisements, letters to cancer survivors from the Comprehensive Breast Program at Dartmoth‐Hitchcock Medical Center and fliers to other medical oncology offices. Randomisation method: computer‐generated assignment No. of participants: 40 (I: 19/ C: 21) Cancer site(s): Stages I‐II breast cancer Age: I: mean = 51.21 (SD = 7.3); C: mean = 49.43 (SD = 5.1) Sex: Female Treatment history: All patients received chemotherapy and were at least 18 months post‐chemotherapy. Use of hormonal therapies (I: 11/C: 12) Co‐morbidities: None reported Education: Completed some years of college or less (I: 3 (30%)/ C: 3 (33%)); College graduate (I: 4 (40%)/ C: 5 (56%)); Post‐college graduate or above (I: 3 (30%); C: 1 (11%)) Socio‐economic status: None reported Cognitive impairment at baseline: Participants had to self‐report persistent memory or attention problems following chemotherapy Country: USA |
|
Interventions |
Definition: Brief CBT Memory and Attention Adaptation Training (MAAT). To assess the efficacy of MAAT on self‐reported and objective cognitive dysfunction related to cancer, as well as QoL Duration: Twice‐weekly 30‐ to 50‐minute sessions for 8 weeks delivered face‐to‐face with telephone follow‐up in between clinics. Participants were encouraged to apply the strategies to daily situations. Components: Four CBT components incorporated into MAAT: Education; Self‐awareness training; Self‐regulation training and; Cognitive compensatory strategy training. MAAT workbook given to each participant. Techniques Feedback on behaviour: telephone contact to reinforce use or modification of strategies Self‐monitoring of behaviour: participants to record 'at‐risk' situations which contribute to cognitive impairment Instruction on how to perform behaviour: learn compensatory strategies, workbook Information about antecedents of behaviour: education about findings and current knowledge regarding cancer‐related cognitive impairment and participants to identify 'at‐risk' situations which lead to cognitive difficulties Information about the health consequences: education about findings and current knowledge regarding cancer‐related cognitive impairment Demonstration of the behaviour: taught compensatory strategies Prompts/cues: telephone contact, external cueing Behavioural practice/rehearsal: rehearse compensatory strategies Generalisation of a target behaviour: application of strategies to everyday life Reduce negative emotions: applied relaxation (Self‐regulation training) and stress‐management Mental rehearsal of successful performance: visualisation strategies Self‐talk: verbal rehearsal, covert verbal self‐instruction (self‐instructional training) Materials: Clinician's manual, participant booklet Theoretical basis/mechanism: CBT/Compensatory strategy training Setting: Face‐to‐face, Dartmouth Medical Centre Therapist/Training: Clinical Psychologist Comparison: Wait‐list control |
|
Outcomes | Outcomes were assessed at baseline, post‐intervention and two‐months intervention with the exception of depression, anxiety and treatment satisfaction. Subjective cognitive function: *MASQ 5 domains (language; visuo‐perceptual; verbal memory; visual memory; attention) Objective cognitive function: CVLT (total raw scores across trials 1‐5) to assess verbal memory; D‐KEFS (trail‐making letter trial; colour‐word interference; colour‐word and switching trials) and WAIS‐III (digit symbol‐coding subset) to assess processing speed. Other outcomes: QOL‐CS 41‐item scale, 5 domains (physical; psychological; social and; spiritual) to assess quality of life; CES‐D to measure depression; STAI to measure anxiety; Treatment satisfaction measured by a study‐specific measure. Adherence: None reported Safety issues: None reported Adverse effects: None reported |
|
Notes | *Primary outcome in Ferguson study. Alternate forms of the CVLT were used to counteract practice effects. Linear interpolation methods used to account for 5 dropouts over the course of the study. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Participants...randomized to treatment and waitlist conditions using computer generated assignment." Pg 178 |
Allocation concealment (selection bias) | Low risk | None reported, however, due to the computerised nature of the allocation it is unlikely that study personnel or participants can predict which allocation is next, however, it may be manipulated by re‐running the software for a given participant. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Not possible to blind the participants to group allocation. "It was impossible to blind the clinician to the treatment or control assignments." Pg 179 |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | "The research assistant completing all assessment and testing was blind to participant group membership." Pg 178 |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reasons for dropout reported and number of dropouts across groups was similar. Pg 180 Intention‐to‐treat analysis was implemented and linear interpolation methods were used to impute missing values. |
Selective reporting (reporting bias) | Unclear risk | Anxiety and depression may not have been outcome measures but were measured to gauge any changes in mood over the course of the study period. However, no numerical data or detailed data included. |
Baseline imbalances in cognition scores Objective outcomes | Unclear risk | No baseline differences between groups are reported. |
Baseline imbalances in cognition scores Subjective outcomes | Low risk | Trend for increased cognitive impairment in intervention group compared to control group, but this is not significant. Pg 182. |
Validity of cognitive function measures Objective outcomes | Unclear risk | Measures chosen for ability to discriminate between survivors who have or have not received chemotherapy. Pg 179. |
Validity of cognitive function measures Subjective outcomes | Unclear risk | No information reported on the validity of outcome. |
Reliability of cognitive function measures Objective outcomes | Unclear risk | No information reported related to reliability of outcome measures. |
Reliability of cognitive function measures Subjective outcomes | Unclear risk | No information reported related to reliability of outcome measure. |