Suzanne C Lechner1, Nicole E Whitehead2, Sara Vargas2, Debra W Annane2, Belinda R Robertson2, Charles S Carver2, Erin Kobetz2, Michael H Antoni2. 1. Department of Psychiatry and Behavioral Sciences (SCL, BRR, MHA), Sylvester Comprehensive Cancer Center (SCL, DWA, CSC, EK, MHA), and Department of Public Health Sciences (EK), University of Miami Miller School of Medicine, Miami, FL; Department of Clinical and Health Psychology, University of Florida, Gainesville, FL (NEW); The Miriam Hospital, The Warren Alpert Medical School of Brown University, Providence, RI (SV); Department of Psychology, University of Miami, Coral Gables, FL (MHA, CSC). SLechner@med.miami.edu. 2. Department of Psychiatry and Behavioral Sciences (SCL, BRR, MHA), Sylvester Comprehensive Cancer Center (SCL, DWA, CSC, EK, MHA), and Department of Public Health Sciences (EK), University of Miami Miller School of Medicine, Miami, FL; Department of Clinical and Health Psychology, University of Florida, Gainesville, FL (NEW); The Miriam Hospital, The Warren Alpert Medical School of Brown University, Providence, RI (SV); Department of Psychology, University of Miami, Coral Gables, FL (MHA, CSC).
Abstract
BACKGROUND: In this randomized trial, Project CARE, we examined whether participation in a cognitive-behavioral stress management and breast cancer wellness and education program improved psychological outcomes among a sample of underserved black breast cancer survivors. METHODS: Both complementary medicine interventions were 10-sessions, manualized, group-based, and were culturally adapted for black women in the community from evidence-based interventions. Participants were 114 black women (mean age = 51.1, 27-77 years) who had completed breast cancer treatment 0-12 months before enrollment (stages 0-IV, mean time since cancer diagnosis = 14.1 months). Women were enrolled upon completion of curative treatment (ie, surgical, chemotherapy, radiation oncology) and randomized to receive cognitive-behavioral stress management or cancer wellness and education program. RESULTS: There was a remarkable 95% retention rate from baseline to 6-month follow-up. Participants in both conditions showed statistically significant improvement on indices of psychological well-being, including overall quality of life (Functional Assessment of Cancer Therapy-Breast), intrusive thoughts (Impact of Event Scale-Revised), depressive symptoms (Center for Epidemiologic Studies-Depression), and stress levels (Perceived Stress Scale) over the 6-month postintervention follow-up (all repeated measures analysis of variance within-subjects time effects: P < .05, except for overall mood; Profile of Mood States-Short Version). Contrary to hypotheses, however, condition × time effects were not statistically significant. CONCLUSIONS: Findings suggest that improvements in multiple measures over time may have been due to intensive training in stress management, extensive provision of breast cancer information, or participation in an ongoing supportive group of individuals from a similar racial background. Implications bear on decisions about appropriate control groups, the timing of intervention delivery during the treatment trajectory, and perceived support from the research team.
RCT Entities:
BACKGROUND: In this randomized trial, Project CARE, we examined whether participation in a cognitive-behavioral stress management and breast cancer wellness and education program improved psychological outcomes among a sample of underserved black breast cancer survivors. METHODS: Both complementary medicine interventions were 10-sessions, manualized, group-based, and were culturally adapted for black women in the community from evidence-based interventions. Participants were 114 black women (mean age = 51.1, 27-77 years) who had completed breast cancer treatment 0-12 months before enrollment (stages 0-IV, mean time since cancer diagnosis = 14.1 months). Women were enrolled upon completion of curative treatment (ie, surgical, chemotherapy, radiation oncology) and randomized to receive cognitive-behavioral stress management or cancer wellness and education program. RESULTS: There was a remarkable 95% retention rate from baseline to 6-month follow-up. Participants in both conditions showed statistically significant improvement on indices of psychological well-being, including overall quality of life (Functional Assessment of Cancer Therapy-Breast), intrusive thoughts (Impact of Event Scale-Revised), depressive symptoms (Center for Epidemiologic Studies-Depression), and stress levels (Perceived Stress Scale) over the 6-month postintervention follow-up (all repeated measures analysis of variance within-subjects time effects: P < .05, except for overall mood; Profile of Mood States-Short Version). Contrary to hypotheses, however, condition × time effects were not statistically significant. CONCLUSIONS: Findings suggest that improvements in multiple measures over time may have been due to intensive training in stress management, extensive provision of breast cancer information, or participation in an ongoing supportive group of individuals from a similar racial background. Implications bear on decisions about appropriate control groups, the timing of intervention delivery during the treatment trajectory, and perceived support from the research team.
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