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

Abstract

Purpose: Younger women are at risk for depression and related symptoms following breast cancer. The Pathways to Wellness study, a randomized, multi-institution, three-arm trial, tested the efficacy of two behavioral interventions for younger breast cancer survivors with elevated depressive symptoms: mindful awareness practices (MAPs) and survivorship education (SE) (Clincaltrials.gov identifier: NCT03025139).

Methods: Women diagnosed with breast cancer at or before 50 years of age who had completed treatment and had elevated depressive symptoms were randomly assigned to 6 weeks of MAPs, SE, or wait-list control (WLC). Assessments were conducted preintervention and postintervention and at 3-month and 6-month postintervention follow-ups. Analyses compared each intervention to WLC using linear mixed models. The primary outcome was change in depressive symptoms from preintervention to postintervention on the Center for Epidemiologic Studies-Depression Scale; secondary outcomes included change in fatigue, insomnia, and vasomotor symptoms.

Results: Two hundred forty-seven women (median age = 46 years) were randomly assigned to MAPs (n = 85), SE (n = 81), or WLC (n = 81). MAPs and SE led to significant decreases in depressive symptoms from preintervention to postintervention relative to WLC (mean change relative to WLC [95% CI]: MAPs, -4.7 [-7.5 to -1.9]; SE, -4.0 [-6.9 to -1.1]), which persisted at 6-month follow-up for MAPs (mean change relative to WLC [95% CI]: MAPs, -3.7 [-6.6 to -0.8]; SE, -2.8 [-5.9 to 0.2]). MAPs, but not SE, also had beneficial effects on fatigue, insomnia, and vasomotor symptoms that persisted at 6-month follow-up (P < .05).

Conclusion: Mindfulness meditation and SE reduced depressive symptoms in younger breast cancer survivors. These interventions can be widely disseminated over virtual platforms and have significant potential benefit for quality of life and overall survivorship in this vulnerable group.

Conflict of interest statement

Ann H. PartridgePatents, Royalties, Other Intellectual Property: I receive small royalty payments for co-authoring the breast cancer survivorship section of UpToDateTravel, Accommodations, Expenses: Novartis Antonio C. WolffConsulting or Advisory Role: Ionis PharmaceuticalsPatents, Royalties, Other Intellectual Property: Antonio Wolff has been named as inventor on one or more issued patents or pending patent applications relating to methylation in breast cancer, and has assigned his rights to JHU, and participates in a royalty sharing agreement with JHUOpen Payments Link: https://openpaymentsdata.cms.gov/physician/357301/summary Hadine JoffeEmployment: MerckLeadership: MerckStock and Other Ownership Interests: Merck, ArsenalBio, Tango TherapeuticsConsulting or Advisory Role: Kandy Therapeutics, Sojournix, Eisai, Jazz PharmaceuticalsResearch Funding: Pfizer, Merck, QUE Oncology, Kandy Therapeutics Patricia A. GanzLeadership: Intrinsic LifeSciencesStock and Other Ownership Interests: Xenon Pharma, Intrinsic LifeSciences, Silarus Therapeutics, Teva, Novartis, Merck, Johnson & Johnson, Pfizer, GlaxoSmithKline, Abbott LaboratoriesConsulting or Advisory Role: InformedDNA, Vifor Pharma, Ambys Medicines, Global Blood Therapeutics, GlaxoSmithKline, Ionis Pharmaceuticals, Akebia Therapeutics, Protagonist Therapeutics, Regeneron, Sierra Oncology, Rockwell Medical Technologies Inc, Astellas Pharma, Gossamer Bio, American Regent, Disc Medicine, Blue Note TherapeuticsResearch Funding: Sierra OncologyPatents, Royalties, Other Intellectual Property: Related to iron metabolism and the anemia of chronic disease, UpToDate royalties for section editor on survivorshipTravel, Accommodations, Expenses: Intrinsic LifeSciencesNo other potential conflicts of interest were reported.

Figures

FIG 1.

CONSORT diagram showing number of women screened, enrolled, and randomly assigned to the three study groups, as well as completion of study assessments. FU, follow-up; MAPs, mindful awareness practices; PHQ-8, Patient Health Questionnaire—8; SE, survivorship education; WLC, wait-list control.

FIG 2.

Adjusted mean scores for depressive symptoms at each assessment in (A) MAPs versus WLC and (B) SE versus WLC. Means are from linear mixed models and are adjusted for study site, race, and marital status. Difference in change since BL; *P < .027 (Dunnett multiplicity threshold); **P < .01; ***P < .001. BL, baseline; CES-D, Center for Epidemiologic Studies-Depression scale; FU, follow-up; MAPs, mindful awareness practices; SE, survivorship education; WLC, wait-list control.

FIG 3.

Adjusted mean scores for (A, B) fatigue, (C, D) insomnia, and (E, F) vasomotor symptoms at each assessment in (A, C, and E) MAPs versus WLC and (B, D, and F) SE versus WLC. Means are from linear mixed models and are adjusted for study site, race, and marital status. Difference in change since BL; *P < .027 (Dunnett multiplicity threshold); **P < .01; ***P < .001. BL, baseline; FSI, Fatigue Symptom Inventory; FU, follow-up; ISI, Insomnia Severity Index; MAPs, mindful awareness practices; SE, survivorship education; WLC, wait-list control.