Abstract P2-11-03: Randomized, single blind trial comparing limited and intensive survivorship interventions following adjuvant therapy in a multiethnic cohort of breast cancer survivors

Abstract

Abstract Background: In 2005, the Institute of Medicine released a report citing the importance of comprehensive treatment summaries or “survivorship plans” for cancer patients completing adjuvant therapy. However, little is known about the best approach or the impact of these interventions on patient well-being. We compared quality of life, treatment satisfaction and cancer impact measures between a minimal or more intensive intervention. Methods: The study was conducted at a single-institution academic breast cancer practice. Women with non-metastatic breast cancer were randomized within six weeks of completing adjuvant therapy (chemotherapy/radiation therapy) to a minimal intervention group (MG) or intensive intervention group (IG). The MG group was given the NCI publication, “Facing Forward: Life after Cancer Treatment” by lay research staff. The intensive group received the same NCI publication; met in person for 1 hour with a nurse practitioner who provided a treatment summary, surveillance and screening recommendations, and information on risk for late effects; and met in person for 1 hour with a nutritionist to review lifestyle recommendations. Subjects were informed that they were in a study of cancer survivors but unaware they were being randomized. The randomization was stratified by ethnicity (Hispanic/non-Hispanic). Both groups completed the 81-item impact of cancer instrument (IOC), functional assessment of chronic illness therapy-treatment satisfaction-patient satisfaction questionnaire (FACIT-TS-PS) and assessment of survivor concerns (AOC) at baseline, 3 and 6 months. Group t-tests and between group linear regression analyses were performed controlling for ethnicity. Results: Of 140 patients who signed consent, 126 women (66 non-Hispanic, 60 Hispanic) completed baseline questionnaires, 109 completed 3 month, and 109 completed 6 month assessments. The groups were well balanced with regard to age (mean = 54), race, marital status, income and employment status. There were no statistically significant differences between the MG and IG on the 8 domains that comprise the FACIT-TS-PS at 3 and 6 months. The health worry scale of the AOC was lower in the IG (p = 0.006) compared to MG, indicating less health worry and the negative outlook score of the IOC was higher in the MG (p = 0.043) compared to IG at 3 months. At baseline, 3 and 6 months, Hispanic women compared to non-Hispanic women had significantly higher (worse) ACS and IOC health worry (p < 0.001), social life interference (p = 0.01) and meaning of cancer scales (p = 0.0004), but also had greater trust in medical professionals (p = 0.029). Conclusions: We did not observe a difference in most of the IOC or treatment satisfaction scores between the MG and IG interventions at 3 or 6 months, nor did we find any significant change from baseline in either group. However, less health worry and less negative outlook were seen in the IG compared to the MG. At baseline and follow-up, Hispanic women in both interventions compared to non-Hispanic women had more extreme scores on most measures. Despite minimal difference between the interventions, the intensive intervention was more time-consuming and used more health care resources. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P2-11-03.