Locke, D.E., Cerhan, J.H., Wu, W., Malec, J.F., Clark, M.M., Rummans, T.A., & Brown, P.D. (2008). Cognitive rehabilitation and problem-solving to improve quality of life of patients with primary brain tumors: A pilot study. Journal of Supportive Oncology, 6, 383–391.

Study Purpose

The primary aim of this study was to examine the feasibility of using cognitive rehabilitation and problem-solving therapies in patients with recently diagnosed primary brain tumors (PBT) and their caregivers. This pilot study was designed to address the lack of knowledge about the potential quality-of-life (QOL) benefits (cognitive dysfunction and emotional distress) of rehabilitative interventions for patients with brain tumors.  
 
A secondary aim was to provide preliminary evidence that a brief, structured rehabilitation intervention for patients with PBT may impact QOL positively. Patient and caregiver feedback regarding the intervention content and procedures served to modify the intervention and to provide an intervention more effectively tailored to meet the needs of these populations.

Intervention Characteristics/Basic Study Process

Interventions delivered concurrently by trained psychologists:
  1. Six sessions (50 minutes) of cognitive rehabilitation focused on purpose of a memory notebook and a calendar with a specific format as an external aid to compensate for cognitive symptoms.   
  2. Six sessions of problem-solving therapy over two weeks focused on the ABC method of constructive thinking and problem solving.
 
Analyses: Wilcoxon signed rank test was used for comparison within groups over time or across groups at same timepoint. Descriptive stats were used for other endpoints.

Sample Characteristics

N: 19 dyads enrolled; 14 completed study with 12 completing three-month follow-up
  • Enrolled: 7 control and 12 Tx
  • Completed CRP: 6 control and 8 Tx
  • Three-month F/U: 5 control and 8 Tx

*Withdrawals were due to tumor progression; new onset seizures; time commitment; caregiver issues; and fatigue.

AGE (enrolled):
  • Tx group: Median 46.5, mean 49.8, range 30–78 years
  • Controls: Median 60, mean 56.6, range 31–71 years
GENDER (enrolled):
  • Tx group: 7 men, 5 women
  • Controls: 4 men, 3 women
KEY DISEASE CHARACTERISTICS: 
    Primary brain tumor
Tumor grade
   • Tx group: Low 5, High 7
   • Controls: Low 1, High 6
Hemisphere
   • Tx group: Right 2, Left 9, Bilateral 1
   • Controls: Right 1, Left 5, Bilateral 1
Treatments
   • Tx: Surgery 7, chemo 7, XRT 11
   • Control: Surgery 3, chemo 5, XRT 7
Time since diagnosis
   • 2 months = 74%
   • 3 months = 79%
   • Other 4 subjects = 22 to 87 months
*A subject 87 months since diagnosis was seen due to recurrence 3 months prior.
 
    Other Key Sample Characteristics: 
            ECOG Performance Status
                • Tx group: 0 = 6, 1 = 5, 2 = 0
                • Controls: 0 = 4, 1 = 2, 2 = 1
 
    Inclusion Criteria
  1. Newly diagnosed PBT prior to or during XRT
  2. 18 years of age or older
  3. Mild or moderate cognitive impairment based on neuropsych testing from the clinical assessment of the neuropsychologist
  4. Prognosis of at least six months
  5. Ability to attend sessions at the institution for two weeks
  6. Designated caregiver must attend all sessions.

Setting

  • SITE: Single site  
  • LOCATION: Mayo Clinic

Study Design

Randomized controlled trial; longitudinal

Measurement Instruments/Methods

Measures were done at baseline, two weeks (upon completion of interventions), and three months.
 
Cognitive Function:
   Repeatable Battery for the Assessment of Neuropsychological Status: Higher scores indicate better cognitive function.
 
Compensation:
   Compensation Techniques Questionnaire: Developed by Mayo Clinic Brain Injury Rehabilitation Program to determine compensation techniques used before and after treatment
 
QOL and Functional Capacity:
  1. Functional Assessment of Cancer Therapy-Brain (FACT-BR): QOL assessment with one subscale specific to common symptoms experienced by those with PBT; completed by patient; higher scores reflect better QOL.
  2. Mayo-Portland Adaptability Inventory-4: Developed to assess patients with traumatic brain injury; measures functional capacity that includes ability, adjustment, and participation indices; completed by patient and caregiver; lower scores indicate better functional status.
QOL and Symptoms:
  1. Linear Analogue Self-Assessment: One item that assesses overall QOL; patients and caregivers complete to describe their own QOL; higher scores indicate better QOL.
  2. Caregiver QOL Index-Cancer: Measures the effect of a patient with cancer's illness on the caregiver’s QOL; completed by caregiver; modified use of \"cancer\" to \"brain tumor\"
  3. Profile of Mood States: Completed by patient and caregiver to describe their own mood; higher scores indicate better emotional adjustment.
  4. Brief Fatigue Inventory: Measures severity of fatigue and impact on daily functioning; completed by patient; higher scores indicate more fatigue.
Study Feedback:
   Post-Study Feedback Questionnaire: Specific to study for subject preferences during intervention and the skills they found most useful

 

Results

Cognitive Function:
  1. Baseline cognitive function (R-BANS) showed that control group scored lower than intervention group for memory.
  2. Baseline cognitive function was used only as a comparison for those who completed all time points in the study as compared to those who did not.
Compensatory Strategy Utilization:
  1. Implementation of compensation strategies was used by 88% of subjects several times/week to several times/day after intervention completion; reduced to 50% at three-month follow-up (88% used at least once/week at three months).
  2. 88% found intervention somewhat helpful to very helpful; 50% found cognitive intervention helpful, whereas 25% found problem-solving most helpful and 25% found both equally helpful; 88% would recommend to another PBT patient; caregivers had similar feedback about the program.

Conclusions

  1. Study demonstrated feasibility of patient participation and satisfaction with cognitive rehabilitation and problem-solving therapies; despite low accrual, most completed program.
  2. Most intervention subjects reported continued use of compensation strategies to some degree at three months.
  3. This sample reported relative stable measures for QOL.
  4. Recommend targeting patients reporting poor QOL, poor day-to-day functional performance, or emotional distress for the intervention.
  5. Recommend larger stratified study to control for varying tumor characteristics and treatment differences (chemotherapy).

Limitations

  1. Small sample size with low accrual over two years. This altered randomization with the last three dyads placed into the intervention group.
  2. Low accrual may have occurred due to the definition used for cognitive impairment as 38% of potential subjects referred for enrollment were not eligible.
  3. Intervention occurred concurrently during radiation therapy treatments for two consecutive weeks, which most likely contributed to low accrual and can increase burden (especially for some who may have continued to work).
  4. Cognitive measure (R-BANS) was utilized for a comprehensive assessment of cognitive function only at baseline. Long-term follow-up was not performed as originally planned with study design.
  5. No educational level was reported for subjects.