Abstract GS2-10: Targeting depressive symptoms in younger breast cancer survivors: A randomized controlled trial of mindfulness meditation and survivorship education
Authors: Ganz Patty , Bower Julienne E , Partridge Ann H , Wolff Antonio C , Thorner Elissa D , Joffe Hadine , Irwin Michael R , Petersen Laura , Petersen Laura , Crespi Catherine M 
Published: February 2021

Abstract
Purpose Breast cancer before age 50 comprises 25% of incident breast cancer cases in women. Younger breast cancer survivors (YBCS) are at increased risk for the negative effects of cancer diagnosis and treatment, including elevated levels of depression and related symptoms (i.e., anxiety, stress, fatigue, sleep disturbance, vasomotor symptoms), leading to significantly diminished quality of life. Patients and Methods This Phase III, randomized, multi-institution trial was designed to examine the efficacy of two brief interventions- mindfulness meditation and survivorship education - for YBCS (ClinicalTrials.gov NCT03025139). We recruited women diagnosed at age 50 or younger with early-stage breast cancer who had completed cancer treatment between 6 months and 5 years earlier and endorsed at least mild depressive symptoms. Participants were randomly assigned to Mindful Awareness Practices (MAPs), Survivorship Education (SE), or wait-list control (WL). Both intervention programs were tailored for YBCS and included 6 weeks of structured content delivered in a group format. Assessments were conducted at baseline, post-intervention, and at 3- and 6- month post-intervention follow-ups. The primary outcome was depressive symptoms (Center for Epidemiologic Studies Depression scale; CESD) at post-intervention; secondary outcomes included anxiety (Generalized Anxiety Disorder-7), fatigue severity (Fatigue Symptom Inventory), sleep disturbance (Insomnia Severity Index), and hot flashes (BCPT symptom checklist). Results We enrolled and randomized 247 women (85 MAPS, 81 SE, 81 WL). On average, participants were 45.4 years old at study entry and had been diagnosed 2.6 years earlier. Linear mixed models were conducted to compare each intervention group to WL on primary and secondary outcomes, controlling for baseline differences across groups in study site, race, and marital status. MAPs led to significant reductions in depressive symptoms at post-intervention and at 3- and 6-month follow-up relative to WL (Ps &lt; .01); see Table 1. SE also led to significant reductions in the CESD at post-intervention and 3-month follow-up (Ps &lt; .01). Both MAPs and SE produced reductions in anxiety at post-intervention relative to WL (Ps &lt; .05), though effects did not persist over follow-up. MAPs also had beneficial effects on other secondary outcomes, yielding significant decreases in fatigue severity, sleep disturbance, and hot flashes that persisted over the 6-month follow-up (Ps &lt; .05). In contrast, there was minimal evidence that SE impacted these outcomes. Conclusion Two brief behavioral intervention programs specially designed for YBCS were effective in reducing depressive symptoms and, in the case of mindfulness, improving related symptoms (fatigue, sleep disturbance) that pose serious threats to younger women’s health and well-being after cancer. These interventions are standardized, manualized, and have the potential for wide dissemination over virtual platforms. Table 1 Adjusted means and standard error (SE) for CESD depressive symptoms by group and time, controlling for study site, race, marital status. A CESD score of 16 or greater indicates moderately severe depressive symptoms. P-values are for differences between intervention and waitlist control groups in change over time between Baseline and Post-Intervention (1-2), Baseline to 3-month Follow-up (1-3), and Baseline to 6-month Follow-up (P 1-4).
BaselinePost-intvP (1-2)3 mo FUP (1-3)6 mo FUP (1-4)GroupCESDCESDCESDPCESDMindful Awareness Practices (MAPs)18.4 (1.0)13.6 (1.1).00113.4 (1.1)&lt;.00112.9 (1.1).013Survivorship Education (SE)17.4 (1.1)13.3 (1.1).00713.6 (1.2).00312.7 (1.2).063Waitlist (WL)16.5 (1.1)16.3 (1.1)17.3 (1.2)14.6 (1.1)
Citation Format: Patty Ganz, Julienne E Bower, Ann H Partridge, Antonio C Wolff, Elissa D Thorner, Hadine Joffe, Michael R Irwin, Laura Petersen, Laura Petersen, Catherine M Crespi. Targeting depressive symptoms in younger breast cancer survivors: A randomized controlled trial of mindfulness meditation and survivorship education [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr GS2-10.