Cognitive Rehabilitation Group Intervention for Breast Cancer Survivors

NCT01540955 | Completed Phase 2 DMC

• 2 other identifiers: 11-003446JCCCID256
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

There are over 2 million breast cancer survivors in the US today. Along with extended survival, many women experience short and long-term after effects of treatment, which may decrease their quality of life and contribute to other health problems. Cognitive complaints---difficulties with memory, concentration, and planning-are commonly reported after adjuvant treatments for breast cancer. This study is designed to test the efficacy of a 5 week group-based cognitive rehabilitation intervention on improving cognitive complaints and test performance, in comparison to women who will receive the same intervention at a later time (wait-list control). Women will also have an EEG test performed before and after the intervention program to see if improvements in cognitive complaints and performance can be documented by examining the EEG.

Conditions

Breast Cancer

Keywords

Reduce Cognitive Complaints; improve cognitive function; post-treatment breast cancer patients

Outcome Measures

Primary Outcomes (1)

• Cognitive function measured by neuropsychological assessment 2 months after group intervention

  2 months

Study Arms (2)

Group Intervention program

EXPERIMENTAL

Behavioral: Improving Cognition with group intervention

Wait-list control group

NO INTERVENTION

The wait-list-control group will also be able to participate in the group intervention, but not until after all the study visits have been completed.

Interventions

Improving Cognition with group intervention BEHAVIORAL

Participants attend 5 weekly group sessions that are 2 hours each, delivered by a trained therapist. Sessions focus on specific aspects of attention, memory, multi-tasking and encoding. Homework assignments are practiced between classes. Goals are set for improved functioning.

Group Intervention program

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• evidence of uncontrolled depression

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Patricia Ganz, M.D.

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 29, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

US (1)