Studies of adherence to cancer treatment find that low-income and minority population experience important barriers (including access barriers) to optimal treatment adherence behavior (helping to explain less favorable morbidity and mortality cancer outcomes among women living in poverty). A randomized clinical trial is proposed to test the efficacy of a multifaceted intervention on patient adherence to breast and gynecological adjuvant cancer treatment and post-treatment follow-up among low-income minority women. The proposed study will test the efficacy of a culturally tailored intervention model that combines interactive health education (decisional support), counseling (emotional support), and systems navigation (resource access) interventions that have been shown to be effective in enhancing adherence to abnormal screening diagnostic follow-up among low-income minority women. The efficacy of IMPAACT will be tested by comparing adherence outcomes between intervention and modestly enhanced usual care group patients. The nature of relationships between assessed barriers, adherence outcomes, and quality of life outcomes and patient satisfaction with the intervention and with their cancer care will be identified. In addition, the study will test models specifying direct, indirect, and intervening relationships between assessed barriers and adherence behaviors within intervention and control groups. In addition, estimates of direct costs of the intervention and usual care arms will be compared. Study Hypotheses: 1.IMPAACT will result in significantly higher rates of: 1) patient acceptance of adjuvant cancer treatment; 2) adjuvant cancer treatment adherence; and 3) follow-up appointment keeping compared to usual care (UC). 2.IMPAACT will result in better functional status, quality of life, and satisfaction with cancer care vs. UC. 3.IMPAACT will result in greater reduction of depressive symptoms (by increasing identification and receipt of treatment) and practical and health system barriers vs. UC. 4.Depression and practical/system barriers will serve as mediators between all other barriers and adherence outcomes. 5 IMPAACT intervention effects will be mediated by changes in targets of the components of the intervention, viz., strengthened intentions, reduced emotional barriers particularly depression, and reduced practical and system barriers.
| Ell, Kathleen; Vourlekis, Betsy; Xie, Bin et al. (2009) Cancer treatment adherence among low-income women with breast or gynecologic cancer: a randomized controlled trial of patient navigation. Cancer 115:4606-15 |
| Ell, Kathleen; Xie, Bin; Wells, Anjanette et al. (2008) Economic stress among low-income women with cancer: effects on quality of life. Cancer 112:616-25 |
| Ell, Kathleen; Sanchez, Kathleen; Vourlekis, Betsy et al. (2005) Depression, correlates of depression, and receipt of depression care among low-income women with breast or gynecologic cancer. J Clin Oncol 23:3052-60 |
