Principal Investigator

Patricia A.
Ganz
Awardee Organization

University Of California Los Angeles
United States

Fiscal Year
2020
Activity Code
R01
Project End Date

A Phase III Randomized Trial Targeting Behavioral Symptoms in Younger Breast Cancer Survivors

Breast cancer is the most common cancer in women younger than 50 years, accounting for up to 25% of new breast cancer cases. Improved survival after a breast cancer diagnosis has focused attention on the critical need to address the impact of the disease and its treatments on long-term outcomes in younger women. This has become an increasingly important cancer control priority, including federal legislation focusing on the unique needs of women <45 years old. Studies have consistently shown that younger women have greater psychological and physical morbidity after breast cancer than older women and age-matched women with no cancer history, including elevated levels of depression and other behavioral symptoms (i.e., fatigue, sleep disturbance, vasomotor symptoms) that cause significant impairment in quality of life. Increased behavioral symptoms have been documented up to 10 years after diagnosis in this population, suggesting that effects may not remediate without intervention. Younger breast cancer survivors are at risk for adverse long-term effects, making them a particularly vulnerable population, for whom only a few specific interventions have been tested. A major barrier to adoption of many behavioral interventions is the lack of a translational research implementation strategy, and thus these interventions fail to become a standard of care that is clinically provided and reimbursed. To meet this challenge, we will conduct a phase III, three-group, randomized clinical trial at three geographically separated NCI-designated comprehensive cancer centers, randomly assigning 360 younger post-treatment breast cancer survivors, to one of two promising interventions (survivorship education or mindful awareness practices), comparing each to a usual care/waitlist control group. We hypothesize that both of the intervention programs will be effective in reducing behavioral symptoms (depression - primary outcome; fatigue, sleep disturbance, vasomotor symptoms-secondary outcomes) over a 6 month postintervention period, in comparison to the usual care/waitlist control group. Additionally, we will examine the efficacy of the interventions relative to the control group on circulating and genomic markers of inflammation, hypothesizing that the mindfulness intervention will significantly reduce markers of inflammation. Finally, we will explore potential moderators of intervention efficacy in the intervention groups.

Publications

  • Bower JE, Kuhlman KR. Psychoneuroimmunology: An Introduction to Immune-to-Brain Communication and Its Implications for Clinical Psychology. Annual review of clinical psychology. 2023 May 9;19:331-359. Epub 2023 Feb 15. PMID: 36791765
  • 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. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2021 Nov 1;39(31):3473-3484. Epub 2021 Aug 18. PMID: 34406839
  • 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. Journal of the National Cancer Institute. 2023 Jan 10;115(1):83-92. PMID: 36130057
  • Bower JE. The role of neuro-immune interactions in cancer-related fatigue: Biobehavioral risk factors and mechanisms. Cancer. 2019 Feb 1;125(3):353-364. Epub 2019 Jan 2. PMID: 30602059
  • Ganz PA, Bower JE, Partridge AH, Wolff AC, Thorner ED, Joffe H, Irwin MR, Petersen L, Crespi CM. Screening for Depression in Younger Breast Cancer Survivors: Outcomes From Use of the 9-item Patient Health Questionnaire. JNCI cancer spectrum. 2021 Feb 8;5. (3). doi: 10.1093/jncics/pkab017. eCollection 2021 Jun. PMID: 34164605
  • Bower JE, Radin A, Kuhlman KR. Psychoneuroimmunology in the time of COVID-19: Why neuro-immune interactions matter for mental and physical health. Behaviour research and therapy. 2022 Jul;154:104104. Epub 2022 May 6. PMID: 35609375

Clinical Trials

Study Name Clinical Trial ID
Mindfulness Meditation or Survivorship Education in Improving Behavioral Symptoms in Younger Stage 0-III Breast Cancer Survivors (Pathways to Wellness) NCT03025139