Use of a tailored clinical intervention for head and neck cancer (HNC) survivors: Findings from the HN-STAR trial (WF-1805CD).

Abstract

671 Background: Comprehensive care of post-treatment HNC survivors requires management of late effects, comorbidities, and health behaviors. We developed HN-STAR: a tailored clinical decision support tool and automated survivorship care plan (SCP) to facilitate survivorship care and improve health-related quality of life (HRQOL). Methods: We conducted a site-randomized controlled trial of oncology practices in the Wake Forest NCI Community Oncology Research Program (NCORP) Research Base (NCT04208490) comparing HN-STAR to Usual Care (UC) during one routine clinic visit. Eligible disease-free survivors completed treatment for HNC <2 years prior. The HN-STAR tool presented survivor’s concerns and tailored recommendations for clinician review during the visit. HN-STAR generated a SCP with clinician-selected management plans, which was updated at 3, 6, and 9 months following online survivor assessments. At baseline and 1 year, survivors in both arms completed the Functional Assessment of Cancer Therapy: HNC (FACT-HN). Comparisons between groups were made by mixed models adjusted for correlation within practices and baseline scores. The primary endpoint was the percentage change in the FACT-HN Trial Outcome Index (TOI), a composite of 3 subscales: physical well-being, functional well-being, and disease-specific concerns. We hypothesized that survivors in the HN-STAR arm would report greater improvement (higher score) in TOI from baseline, compared to survivors in the Usual Care arm. Results: Among 357 survivors (mean age 64 years, 23% Hispanic or Non-White, 26% rural) at 26 practices, 262 (114 HN-STAR, 148 Usual Care) completed baseline and follow-up FACT-HN. There were no differences in FACT-HN scores at baseline between arms. At 1 year, TOI scores and scores for physical, emotional, functional, and HNC subscales improved overall at 1 year (p’s<.05). Between study arms, there was no difference in the change in TOI or subscales from baseline to 1 year. Conclusions: In a national sample of post-treatment HNC survivors, a tailored survivorship intervention had no effect on HRQOL over one year. A single visit using HN-STAR, with remote check-ins, may be insufficient to improve long-term HRQOL. Clinical trial information: NCT04208490 . Mean FACT-HN scores (SD). Scales (range) Baseline HN-STAR Baseline UC 1 YearHN-STAR 1 YearUC Difference HN-STAR Difference UC p-value TOI (0-96) 67.7 (16.2) 68.5 (16.2) 72.0 (16.7) 71.2 (16.4) 4.9 (10.5) 2.7 (11.3) .30 Physical (0-28) 23.1 (4.3) 22.6 (4.9) 24.0 (4.7) 23.4 (4.7) 1.1 (3.2) 0.8 (3.7) .89 Social (0-28) 22.2 (5.2) 21.4 (6.0) 22.1 (5.8) 21.5 (6.4) -0.1 (4.9) 0.1 (5.0) .31 Emotional (0-24) 19.8 (4.0) 19.3 (4.1) 19.9 (4.2) 20.0 (4.0) 0.2 (3.2) 0.6 (3.6) .66 Functional (0-24) 19.2 (6.1) 19.1 (6.3) 20.3 (6.4) 19.9 (6.7) 1.3 (4.6) 0.8 (5.6) .98 HNC concerns (0-40) 25.4 (7.7) 26.8 (7.3) 27.8 (7.3) 27.9 (7.1) 2.4 (5.6) 1.1 (5.2) .24 UC=usual care.