Mihuta, M.E., Green, H.J., & Shum, D.H.K. (2018). Web-based cognitive rehabilitation for survivors of adult cancer: A randomised controlled trial. Psycho-Oncology, 27, 1172–1179.

DOI Link

Study Purpose

Randomized, wait-list controlled study conducted to evaluate the efficacy of a web-based cognitive rehabilitation therapy (CRT) program for adults with non-central nervous system tumors and cognitive complaints.

Intervention Characteristics/Basic Study Process

The web-based CRT program (eReCog) was adapted from an in-person manualized format (ReCog). Participants completed four 30- to 60-minute online modules (one each week). Learning techniques involved psychoeducation, relaxation, strategy training, and homework. On-line discussion and questions were anonymized. The program content included (a) ageing, health, cancer, cognitive function, (b) memory, (c) attention, (d) fatigue, emotions, and cognition. Module links were emailed to participants. Participant module progression was tracked. Module completion triggered receipt of the next consecutive module. Feedback on individualized goal setting (after Module 1) was provided via email. On-line questionnaires were administered at baseline, four weeks, and three months. Primary endpoint: perceived cognitive impairment. Secondary endpoints: objective cognitive function, psychosocial variables.

Sample Characteristics

  • N = 71   
  • MEAN AGE: 56.01 years (extrapolated from report of separate group means. No range reported)
  • FEMALES: 71%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: Non-central nervous system adult on-set (18 years or older) malignancies; at least 6 months post-primary treatment. 
  • OTHER KEY SAMPLE CHARACTERISTICS: Complaints of memory or concentration issues participants attributed to their cancer experience. Concurrent endocrine therapy allowed. Exclusion for history of traumatic brain injury, neurological disorder, or uncontrolled anxiety or depression. Fluency in English required.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Home    
  • LOCATION: Investigators were based at two academic centers (Australia and China), but demographics related to participants’ location is not reported.

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Study Design

Randomized, wait-list controlled design. Powered to detect small to moderate interaction effects (80% power, alpha = 0.05) with 20% added to account for attrition (goal: n = 65).

Measurement Instruments/Methods

  • Functional Assessment of Cancer Therapy-Cognitive Scale (FACT-Cog-3)
  • Brief Assessment of Prospective Memory Instrumental Activities of Daily Living (IADL) subscale
  • WebNeuro (online test battery for verbal and working memory, attention, response speed, information processing efficiency, executive function, impulsivity)
  • Kessler Psychological Distress Scale
  • Brief Illness Perception Questionnaire (BIPQ)
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) fatigue symptom scale

Results

Intervention group reported significant reduction in prospective memory failures post-intervention (p = 0.005) and three months (p < 0.001). Wait list-controls reported a significant reduction at three months (p = 0.02). Intervention group demonstrated clinically meaningful improvement for FACT-Cog PCI subscale scores (minimally important difference > 6.5, actual improvement 8.9 versus 5.6 for controls) post intervention.

Within-group improvement noted for intervention group on FACT-Cog PCA subscale post intervention (p = 0.002, d = 0.3) and three months (p = 0.007, d = 0.42). Controls improved at three months (p = 0.032, d = 0.22). Intervention group reported decrease in impact of cognitive issues on QOL post-intervention (p = 0.007, d = 0.26) and three months (p = 0.005, d = 0.56). Controls reported decreased impact at three months (p = 0.04, d = 0.24). No interactions were noted for objective neurocognitive measures, distress, or BIPQ. Fatigue was reduced postintervention for the intervention group (p = 0.046, d = 0.27), but not at three months. Participants’ satisfaction ratings were high (94%), and 68% reported “a little or a lot” of improvement in cognitive function.

Conclusions

Preliminary evidence demonstrated in support of this web-based CRT (eReCog) as an effective intervention for self-reported issues with cognitive function following primary treatment for breast cancer. Feasibility and satisfaction demonstrated for use of this web-based CRT.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Findings not generalizable
  • Subject withdrawals ≥ 10%  
  • Other limitations/explanation: No supervision for completion of study questionnaires may allow unknown influences and/or interruptions. Sample was 100% female and 98.5% breast cancer; therefore, generalization of findings is limited. Statistical analyses included multiple comparisons. Group allocation was made following initial expression of interest and participants were informed of group allocation at the time consent confirmation was secured via email. In addition, participants’ knowledge of the expected outcome for the intervention may have induced some placebo effect.

Nursing Implications

Future research with a larger sample size is needed to confirm the impact of web-base CRT (on both subjective and objective measures of cognitive function) in the breast cancer survivor population. Web-based CRT has the potential to increase access and decrease cost/burden associated with intervention delivery.