Randomized trial of community-based patient assistance to improve breast cancer care

Background: Unmet needs may affect breast cancer patients' receipt of adjuvant therapy and quality of life. High quality community-based cancer assistance programs abound that can address women's informational, psychosocial and practical needs. We identified newly diagnosed and operated breast cancer patients' needs and randomized women to high quality community-based assistance programs that can meet those needs vs usual care. Methods: 263 women with new breast cancer operated at 8 NYC hospitals participating in the RCT completed the 6 month follow-up survey assessing functional status, treatments received, perceptions and demographics. Based on women's needs, preferred mode of receipt of help, we informed the intervention group of appropriate programs, enabled program connection, and for those unconnected at 2 weeks, identified barriers to connection and reinforced plans to connect. Controls received a pamphlet about breast cancer. Results: On average, women were 56 years old, had completed 14 yrs of school, 28% lived in poverty and 45% were white. Of the 263, 161 (61%) had informational, 145 (55%) psychosocial and 141 (54%) practical needs and 61 (23%) expressed no needs. Only 60 (23%) had 1 need, 39 (15%) 2 needs and 103 (39%) 3 needs. There were no significant differences between intervention and control groups in age, education, income, race, physical or emotional functional status (SF12), social support or needs at baseline. 27% of women with breast conserving surgery did not get RT (50/182) and 7% of those requiring chemo-or hormonal therapy did not receive it (15/216); there were no treatment differences between intervention and control groups. Of the 202 women expressing one or more needs, 12% had all needs met, 53% had no needs met and 35% had some needs met; there was no difference between intervention and control groups getting needs met. Conclusion: Despite providing information and enabling and tailoring connection to high quality community-based patient assistance programs, there is no difference between intervention and control groups' receipt of adjuvant treatment or receipt of patient assistance. The lack of effect may be due to similar rates of patient assistance use and having needs met in both intervention and control groups.