Memory Training Intervention for Breast Cancer Survivors

NCT01497015 | Completed

• 1 other identifier: 64194
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial to evaluate the ACTIVE memory training intervention and ACTIVE speed of processing training to waitlist, no-contact control conditions. Specific aims and hypotheses are: Aim 1: Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors (BCS). Hypothesis 1: BCS assigned to the memory intervention arm will perceive the intervention as more acceptable and useful than BCS assigned to the attention control condition. Aim 2: Establish preliminary efficacy of the ACTIVE memory training intervention relative to the attention control and no-contact control conditions. Hypothesis 2: Memory training will result in greater memory enhancement immediately post and 2-months post-intervention relative to attention control or no-contact control conditions.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Memory Performance

  Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors.

  Baseline, immediately post intervention

• Memory Performance

  Evaluate the acceptability and usefulness of the ACTIVE memory intervention among Breast Cancer Survivors.

  2-month post intervention

Secondary Outcomes (4)

• Subjective Cognitive Function

  baseline, immediately post intervention

• Subjective Cognitive Function

  2-month follow-up

• Symptom distress

  baseline, immediately post intervention

• Symptom distress

  2-month follow-up

Study Arms (3)

memory training

EXPERIMENTAL

memory training 10 1-hour sessions with interventionist to be delivered over 6-8 weeks

Behavioral: memory training

speed of processing training

EXPERIMENTAL

Speed of processing training 10 1-hour sessions delivered over 6-8 weeks

Behavioral: speed of processing training

waitlist control

EXPERIMENTAL

Breast cancer survivors will be randomized to 1 of 3 groups: memory training, speed of process training or waitlist control

Behavioral: waitlist control

Interventions

memory training BEHAVIORAL

10 1-hour sessions over 6-8 weeks

memory training

speed of processing training BEHAVIORAL

10 1-hour sessions delivered over 6-8 weeks

speed of processing training

waitlist control BEHAVIORAL

Breast cancer survivors will receive the speed of processing training compact disc in the mail after study completion.

waitlist control

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female gender (breast cancer is rare in men);
• self-reported memory impairment and desire for treatment (to focus on BCS in greatest need);
• first diagnosis of non-metastatic breast cancer (to control for multiple treatments or brain metastases in women with recurrent or metastatic disease);
• ≥ 1 year post-treatment including surgery, radiation, and/or chemotherapy (reduce confounding factors related to acute effects of treatment);32
• age ≥ 40 years (our prior studies indicate approximately 75% of BCS meet this criterion and reduce sample variability);
• post-menopausal (majority are post-menopausal at diagnosis and reduce sample variability); and
• able to read, write, understand, and speak English (to ensure informed consent).

You may not qualify if:

• Women will be excluded if they have other co-morbidities or deficits that would sufficiently impair performance or inhibit cognitive training including:
• substantial cognitive decline (score \< 24 on the Mini Mental State Exam (MMSE);33
• history of stroke, encephalitis, traumatic brain injury, brain surgery, dementia, Alzheimer disease, or Parkinson disease;
• cranial radiation therapy or intrathecal therapy;
• current active major depression or substance abuse or history of bipolar disorder, psychosis, schizophrenia, or learning disability;
• history of or current other cancer except for basal cell skin cancer; or
• receiving other cognitive training (to avoid exposure to other training).

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Diane Von Ah, PhD, RN, CNA

  Indiana University

  PRINCIPAL INVESTIGATOR

• Andrew Saykin, PsyD

  Indiana University

  STUDY DIRECTOR

• Frederick Unverzagt, PhD

  Indiana University

  STUDY DIRECTOR

• Janet Carpenter, PhD, RN

  Indiana University

  STUDY DIRECTOR

• Patrick Monahan, PhD

  Indiana University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department Chair, School of Nursing

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 22, 2011
• Study Start: September 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

US (1)