Efficacy of MBSR Treatment of Cognitive Impairment Among Breast Cancer Survivors

NCT02786797 | Completed DMC

• 1 other identifier: 1R01CA199160-01
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to evaluate MBSR(BC), an intensive meditation-based stress reduction intervention, in order to determine its efficacy in improving cognitive functioning among breast cancer survivors. The study will employ a three group randomized design that will (1) evaluate the extent to which MBSR(BC) compared to the Breast Cancer-Education Support (BCES) program or Usual Care (UC) improves cognitive functioning among breast cancer survivors off treatment; (2) determine if improvements in cognitive functioning achieved from MBSR(BC) are mediated through increased mindfulness and decreased rumination and stress; (3) evaluate genetic variants as moderators of MBSR(BC) on improvements in CI; and (4) determine the impact of MBSR(BC) on healthcare utilization and costs, in addition it will be delivered to a sub-group in Spanish. If shown to be efficacious, the possibility exists of utilizing this intervention in other types of cancers as well as non-cancer health-related disorders in order to minimize the morbidity experienced by these populations.

Conditions

Breast Cancer

Keywords

breast cancer; mindfulness-based stress reduction; cognitive impairment

Outcome Measures

Primary Outcomes (1)

• Change in Executive Functioning from baseline to 6 months.

  Executive functioning is assessing the ability to develop, carry out, and make necessary changes to plans that have a goal. This will be measured using the Stroop Neuropsychological Screening Test (SNST).

  Baseline, 6 weeks (post intervention), 12 weeks follow-up and 6 months follow-up.

Secondary Outcomes (7)

• Change in Executive Function from baseline to 6 months.

  Baseline, 6 weeks (post intervention), 12 weeks follow-up and 6 months follow-up.

• Change in Visuospatial Memory from baseline to 6 months.

  Baseline, 6 weeks (post intervention), 12 weeks follow-up and 6 months follow-up.

• Change in Verbal Memory from baseline to 6 months.

  Baseline, 6 weeks (post intervention), 12 weeks follow-up and 6 months follow-up.

• Change in Logical Memory from baseline to 6 months.

  Baseline, 6 weeks (post intervention), 12 weeks follow-up and 6 months follow-up.

• Change in Attention and Concentration from baseline to 6 months.

  Baseline, 6 weeks (post intervention), 12 weeks follow-up and 6 months follow-up.

Study Arms (3)

MBSR(BC) 6 Week Program

EXPERIMENTAL

Participants who are randomized to MBSR(BC) program will receive of educational material; group practice of mindfulness meditation (MM) and homework assignments; and group processes related to the practice of MM and supportive group interaction. Participants who receive MBSR will receive training in (1) sitting meditation anchored to the breath; (2) body scan (observing body sensations from the toes to the head); (3) Gentle Yoga (postures and stretches that increase awareness and balance; and (4) walking meditation. Through this arm of the study the goal is to enhance executive cognition through training in self-regulation of attention and acceptance of experience.

Behavioral: MBSR(BC) 6 Week Program

BCES Education Support Program

ACTIVE COMPARATOR

Participants who are randomized to the BCES program will be scheduled for 6 weekly, 2-hour sessions. BCES compared to MBSR(BC) meets the following criteria: (1) professional contact and group support time matched equally to the MBSR(BC) program; and (2) the content or activities of the BCES program does not include meditation or attention, relaxation, yoga, body scan, or walking meditation. This program is as an active control condition that accounts for nonspecific effects related to attention from the leader and favorable outcome expectancy, the educational materials provided and supportive interaction between group members and is matched for homework activity time over the 6 months. This group will be offered the MBSR(BC) program within 4 to 6 months after study completion.

Behavioral: BCES 6 Week Program

Usual Care

NO INTERVENTION

Participants who are randomized to the Usual Care (UC) or control group will continue to receive standard post-treatment medical and nursing clinic visits that will not be modified by study participation. The UC participants will participate in their standard care appointments and will not be required to alter their UC regimen; however, they will be asked not to initiate a mindfulness program during the study period. The UC group will be offered the MBSR(BC) program within 4 to 6 months after study completion.

Interventions

MBSR(BC) 6 Week Program BEHAVIORAL

The MBSR(BC) is a clinical program that provides systematic training to promote stress reduction by self-regulating arousal to stress. The goal of training is to teach participants to become more aware of their thoughts and feelings, and through meditation practice, to have the ability to step back from thoughts and feelings during stressful situations that contribute to increased emotional distress. It incorporates simple yoga, sitting meditation, body scan, and walking meditation in this program. Classes for this intervention occur on a weekly basis for 2 hours for 6 weeks. The participants will be asked to record their informal/formal practices in a daily diary during the program and from 6 weeks to 6 months after the intervention.

MBSR(BC) 6 Week Program

BCES 6 Week Program BEHAVIORAL

The BCES is an education support program. This 6-week program is based on the published NIH program, "Support for People with Cancer: Taking Time Education Support Group." In addition the class sessions consist of group discussion of educational materials and homework assignments; and group processes related to sharing supportive care situations. The participants will record their feelings, coping mechanisms, and questions related to survivorship in a daily diary during the program and from 6 weeks to 6 months after the intervention.

BCES Education Support Program

Eligibility Criteria

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

You may qualify if:

• Women age 21 or older who have:
• a diagnosis of stage I, II, or III breast cancer;
• completed CT or CT and radiation and are within 5 years post-treatment;
• BC patients with a previous history of another cancer who have NOT received any chemotherapy or chemotherapy and radiation, but have only received surgical treatments are eligible;
• met the screening criteria for CI through a positive response to at least 1 of 2 scaled questions from the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ) i.e. Please rate on a scale from 0 to 10, the difficulty level you have in concentrating on things, like reading a newspaper or watching television? "0" means no difficulty and "10" means very difficult. Please rate on a scale from 0 to 10, the difficulty level you have in remembering things. "0" means no difficulty and "10" means very difficult, will be included.
• Subjects must have the ability to read and speak English and Spanish at the 8th grade level or above, and survivors with mild depression, anxiety, or other psychiatric conditions will be eligible.

You may not qualify if:

• Breast cancer survivors with a severe current psychiatric diagnosis (e.g. bipolar disorder)
• Stage 0 or Stage IV BC
• History of another primary cancer diagnosis, treated with adjuvant chemotherapy
• Previous chemotherapy
• Current diagnosed neurologic disorder
• Or a traumatic brain injury will be excluded

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (5)

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

USF Health Carol and Frank Morsani Center

Tampa, Florida, 33612, United States

Location

Florida Hospital Tampa

Tampa, Florida, 33613, United States

Location

Related Publications (3)

• Lengacher CA, Hueluer G, Wang JR, Reich RR, Meng H, Park JY, Kip KE, Morgan S, Joshi A, Tinsley S, Krothapalli M, Nidamanur S, Cox C, Kiluk J, Lucas JM, Fonseca T, Moscoso MS, Bornstein E, Donovan KA, Padgett LS, Chamkeri R, Patel D, Hornback E, Rodriguez CCS. A Randomized Clinical Trial of Mindfulness-Based Stress Reduction Program Among Breast Cancer Survivors Post-Treatment: Evaluating Mediators of Cognitive Improvement. J Integr Complement Med. 2025 Apr;31(4):367-377. doi: 10.1089/jicm.2024.0493. Epub 2024 Dec 23.

  PMID: 39711191 DERIVED

• Park JY, Lengacher CA, Rodriguez CS, Meng H, Kip KE, Morgan S, Joshi A, Hueluer G, Wang JR, Tinsley S, Cox C, Kiluk J, Donovan KA, Moscoso M, Bornstein E, Lucas JM, Fonseca T, Krothapalli M, Padgett LS, Nidamanur S, Hornback E, Patel D, Chamkeri R, Reich RR. The Moderating Role of Genetics on the Effectiveness of the Mindfulness-Based Stress Reduction for Breast Cancer (MBSR(BC)) Program on Cognitive Impairment. Biol Res Nurs. 2025 Apr;27(2):216-228. doi: 10.1177/10998004241289629. Epub 2024 Oct 16.

  PMID: 39413359 DERIVED

• Lengacher CA, Reich RR, Rodriguez CS, Nguyen AT, Park JY, Meng H, Tinsley S, Hueluer G, Donovan KA, Moscoso MS, Bornstein E, Kiluk J, Nidamanur S, Padgett LS, Lucas JM, Fonseca T, Joshi A, Lin KJ, Goodman M, Kip KE. Efficacy of Mindfulness-Based Stress Reduction for Breast Cancer (MBSR(BC)) a Treatment for Cancer-related Cognitive Impairment (CRCI): A Randomized Controlled Trial. J Integr Complement Med. 2025 Jan;31(1):75-91. doi: 10.1089/jicm.2024.0184. Epub 2024 Sep 18.

  PMID: 39291332 DERIVED

Related Links

• The 6-week curriculum is based on the published NIH program, "Support for People with Cancer: Taking Time Education Support Group."

MeSH Terms

Conditions

Breast Neoplasms; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: June 1, 2016
• Study Start: March 7, 2016
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)