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Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors


Phase 2
21 Years
65 Years
Open (Enrolling)
Both
Breast Cancer

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Trial Information

Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors


Previous pilot work (non-randomized, pre-post design) has shown that this intervention was
effective in improving post-intervention cognitive complaints and neuropsychological (NP)
test performance. Because practice effects may influence NP performance, it is important to
compare the intervention participants to women who are not exposed to the intervention.
Thus, this randomized controlled trial will compare the active intervention to a control
group of patients who will receive the intervention at a delayed time point. The primary
outcomes are improvements in cognitive complaints and NP test performance 2 months after
completion of the intervention program. Quantitative EEG (QEEG) measurements will be used
as a secondary exploratory endpoint to see if this may be an effective biomarker of
cognitive performance.


Inclusion Criteria:



- age 21-65 years

- stage I, II, III breast cancer diagnosis within the past 18 months to 5 years

- currently disease free, but may be on endocrine therapy

- with evidence of need of cognitive therapeutic intervention, as demonstrated by mild
or greater cognitive deficiencies on an objective screening measure

- reads and writes English

- able to give informed consent

- willing and able to attend 5 weekly group sessions and participate in pre and
post-evaluation that will take place on the UCLA campus

Exclusion Criteria:

- evidence of uncontrolled depression

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Cognitive function measured by neuropsychological assessment 2 months after group intervention

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

Patricia Ganz, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

11-003446

NCT ID:

NCT01540955

Start Date:

March 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • Reduce Cognitive Complaints
  • improve cognitive function
  • post-treatment breast cancer patients
  • Breast Neoplasms

Name

Location

UCLALos Angeles, California  90095