Clinical trial · Interventional
Efficacy of MBSR Treatment of Cognitive Impairment Among Breast Cancer Survivors
NCT02786797CI-TRIAL-00046236completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCES 6 Week Program | Behavioral | — | UNRESOLVED |
| MBSR(BC) 6 Week Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- MBSR(BC) 6 Week Program
- description
- 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.
- interventionNames
- Behavioral: MBSR(BC) 6 Week Program
- type
- ACTIVE_COMPARATOR
- label
- BCES Education Support Program
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria:
* Women age 21 or older who have:
1. a diagnosis of stage I, II, or III breast cancer;
2. completed CT or CT and radiation and are within 5 years post-treatment;
3. 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;
4. 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.
5. 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.
Exclusion Criteria:
* 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 excludedReferences
Publications (3)
- DERIVEDLengacher 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
- DERIVEDPark 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
- DERIVEDLengacher 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