Clinical trial NCT03025139: Mindfulness Meditation or Survivorship Education in Improving Behavioral Symptoms in Younger Stage 0-III Breast Cancer Survivors (Pathways to Wellness)
Official title: Improving Outcomes for Younger Breast Cancer Survivors: A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2017-01-19
Enrollment: 96
Sex: FEMALE
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in depressive symptoms measured by Center for Epidemiologic Studies Depression Scale score
timeFrame: 2 weeks post-intervention to 6 months
Secondary outcomes:
measure: Change in fatigue assessed by Fatigue Symptom Inventory
timeFrame: 2 weeks post-intervention to 6 months
measure: Change in hot flashes measured by the vasomotor symptom severity subscale of the BCPT symptom scales questionnaire.
timeFrame: 2 weeks post-intervention to 6 months
measure: Change in inflammatory biomarkers will focus on laboratory measurements of Interleukin-6 (IL-6) and high sensitivity C-Reactive Protein (hsCRP)
timeFrame: 2 weeks post-intervention to 6 months
measure: Change in sleep disturbance assessed by Insomnia Severity Index
timeFrame: 2 weeks post-intervention to 6 months
measure: Mediators of intervention efficacy assessed by questionnaire
timeFrame: Up to 6 months
measure: Moderators of intervention efficacy assessed by questionnaire
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University/Sidney Kimmel Cancer Center
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Patricia Ganz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bower JE, Partridge AH, Wolff AC, Cole SW, Irwin MR, Thorner ED, Joffe H, Petersen L, Crespi CM, Ganz PA. Improving biobehavioral health in younger breast cancer survivors: Pathways to Wellness trial secondary outcomes. J Natl Cancer Inst. 2023 Jan 10;115(1):83-92. doi: 10.1093/jnci/djac180.
citation: Bower JE, Partridge AH, Wolff AC, Thorner ED, Irwin MR, Joffe H, Petersen L, Crespi CM, Ganz PA. Targeting Depressive Symptoms in Younger Breast Cancer Survivors: The Pathways to Wellness Randomized Controlled Trial of Mindfulness Meditation and Survivorship Education. J Clin Oncol. 2021 Nov 1;39(31):3473-3484. doi: 10.1200/JCO.21.00279. Epub 2021 Aug 18.