Mindfulness Meditation or Survivorship Education in Improving Behavioral Symptoms in Younger Stage 0-III Breast Cancer Survivors (Pathways to Wellness)

Conditions

Cancer Survivor, Early-Stage Breast Carcinoma, Stage 0 Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

Keywords

breast cancer, younger women, education, mindfulness meditation, depression, cancer survivor

Brief summary

This randomized phase III trial studies how well mindfulness meditation or survivorship education work in improving behavioral symptoms in younger stage 0-III breast cancer survivors. Behavioral interventions, such as mindfulness meditation, use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Survivorship education after treatment may reduce stress and improve the well-being and quality of life of patients with breast cancer. Mindfulness meditation or survivorship education may help improve the health behaviors of younger breast cancer survivors.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of two different types of group interventions (mindfulness and survivorship education), specifically tailored to the needs of younger female breast cancer survivors, in reducing depressive symptoms, compared to a usual care control group. SECONDARY OBJECTIVES: I. To compare the efficacy of the two interventions relative to a usual care control group on fatigue, sleep disturbance, and vasomotor symptoms. II. To examine the efficacy of the two interventions relative to a usual care control group on circulating and genomic markers of inflammation. III. To explore potential moderators and mediators of intervention efficacy in the two intervention groups. OUTLINE: Patients are randomized to 1 of 3 arms. ARM A (MINDFULNESS AWARENESS PRACTICES \[MAPs\]): Patients attend a mindfulness meditation class over 2 hours once weekly for 6 weeks. Patients then attend in person booster sessions that include guided meditation, questions, and discussion of how to maintain a mindfulness practice over 1 hour once monthly for 3 months. ARM B (SURVIVORSHIP EDUCATION INTERVENTION \[SE\]): Patients attend a survivorship education class over 2 hours once weekly for 6 weeks. Patients also receive monthly electronic newsletters with tailored information about topics of interest to younger survivors, including cancer-related events in the community and tips about following through on recommendations for healthy living. ARM C (USUAL CARE/DELAYED TREATMENT CONTROL GROUP): Patients receive usual care for 9 months. Patients are then offered a choice of participating in Arm A or Arm B. After completion of study, patients are followed up at 3 and 6 months.

J. Richard Korecki, Patricia A. Ganz, Ann H. Partridge, Antonio C. Wolff, Laura A. Petersen et al. (7 authors)

Psychosomatic Medicine2024-08-102 citations

10.1097/psy.0000000000001340

Moderators of Intervention Efficacy in the Pathways to Wellness Trial of Survivorship Education and Mindfulness Meditation for Younger Breast Cancer Survivors

J. Richard Korecki, Patricia A. Ganz, Ann H. Partridge, Antonio C. Wolff, Laura Petersen et al. (7 authors)

JCO Oncology Practice2024-06-252 citations

10.1200/op.23.00617

Improving biobehavioral health in younger breast cancer survivors: Pathways to Wellness trial secondary outcomes

Julienne E. Bower, Ann H. Partridge, Antonio C. Wolff, Steve W. Cole, Michael R. Irwin et al. (10 authors)

JNCI Journal of the National Cancer Institute2022-09-2011 citations

10.1093/jnci/djac180

Targeting Depressive Symptoms in Younger Breast Cancer Survivors: The Pathways to Wellness Randomized Controlled Trial of Mindfulness Meditation and Survivorship Education

Julienne E. Bower, Ann H. Partridge, Antonio C. Wolff, Elissa Thorner, Michael R. Irwin et al. (9 authors)

Journal of Clinical Oncology2021-08-1860 citations

10.1200/jco.21.00279

Abstract GS2-10: Targeting depressive symptoms in younger breast cancer survivors: A randomized controlled trial of mindfulness meditation and survivorship education

P. A. Ganz, Julienne E. Bower, Ann H. Partridge, Antonio C. Wolff, Elissa Thorner et al. (10 authors)

Cancer Research2021-02-151 citations

10.1158/1538-7445.sabcs20-gs2-10

Interventions

OTHEREducational Intervention

Attend survivorship education

OTHERLaboratory Biomarker Analysis

Correlative studies

PROCEDUREMeditation Therapy

Attend mindfulness meditation

OTHERQuestionnaire Administration

Ancillary studies

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

No minimum to 49 Years

Healthy volunteers

No

Inclusion criteria

* Women diagnosed with early stage, resectable breast cancer (Stage 0, I, II, or III) prior to age 50, and are within 5 years of diagnosis * Have completed all surgery, radiation, and/or chemotherapy treatments at least 6 months previously; may still be receiving trastuzumab or endocrine adjuvant therapy * Ability to complete evaluation surveys in English * Have evidence of at least mild clinical depression on a standardized screening questionnaire

Exclusion criteria

* Has a breast cancer recurrence, metastasis, or another interval cancer diagnosis following the breast cancer (excluding non-melanoma skin cancer) * Unable to commit to intervention schedule (6 weekly group meetings) * Actively practicing mindfulness meditation * Has another serious or chronic medical or psychiatric condition that contributes to substantial physical or emotional disability that would detract from participating in either of the intervention programs or from the measurement of intervention outcomes

Design outcomes

Primary

Measure	Time frame	Description
Change in depressive symptoms measured by Center for Epidemiologic Studies Depression Scale score	2 weeks post-intervention to 6 months	The data will be analyzed using linear mixed effects models, with fixed effects for time and condition and random effects for individuals. Differences between conditions in change over time will be examined by testing condition-by-time interaction terms. All tests will be two-sided. The Hochberg procedure will be applied to the two p-values for each intervention to control the familywise error rate at 0.05.

Secondary

Measure	Time frame	Description
Change in hot flashes measured by the vasomotor symptom severity subscale of the BCPT symptom scales questionnaire.	2 weeks post-intervention to 6 months	Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.
Change in inflammatory biomarkers will focus on laboratory measurements of Interleukin-6 (IL-6) and high sensitivity C-Reactive Protein (hsCRP)	2 weeks post-intervention to 6 months	Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.
Change in fatigue assessed by Fatigue Symptom Inventory	2 weeks post-intervention to 6 months	Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.
Mediators of intervention efficacy assessed by questionnaire	Up to 6 months	Mediators assessed will include self-efficacy, mindfulness, self-kindness, and rumination.
Moderators of intervention efficacy assessed by questionnaire	Up to 6 months	Moderators will include preparedness for survivorship, intervention preference, and childhood adversity. Will be assessed using condition-by-moderator interaction terms in mixed models.
Change in sleep disturbance assessed by Insomnia Severity Index	2 weeks post-intervention to 6 months	Will be tested using the mixed modeling approach, and p-values reported both with and without multiplicity adjustment. All tests will be two-sided.

Countries

United States

Outcome results

None listed