Shared Local Oncology Care After Allogeneic Hematopoietic Cell Transplantation: A Randomized Clinical Trial.

IMPORTANCE

Although sharing care with local oncologists after allogeneic hematopoietic cell transplantation (HCT) has been proposed for patients living far from HCT centers, it is not known whether a shared strategy is safe or improves patient quality of life (QOL).

OBJECTIVE

To determine the efficacy and safety of sharing follow-up care after HCT between the HCT specialty center and local oncologists.

DESIGN, SETTING, AND PARTICIPANTS: This was a multicenter collaborative randomized clinical trial of patients undergoing HCT at Dana-Farber Cancer Institute (DFCI)-a high volume HCT center in Boston (Massachusetts)-and 8 local oncology practices. Eligible patients were enrolled from December 2017 to December 2021 and were randomized 1:1 to shared vs usual care after neutrophil engraftment, stratified by local sites in Massachusetts, Rhode Island, New Hampshire, New York, and Maine. Data analyses were performed in January 2024.

INTERVENTION

Shared care involved alternating post-HCT visits at DFCI and local oncology practices through day 100; for usual care, all post-HCT visits occurred only at DFCI.

MAIN OUTCOMES AND MEASURES

Coprimary outcomes were nonrelapse mortality (NRM) at day 100, and QOL measured by the FACT-BMT (Functional Assessment of Cancer Therapy-Bone Marrow Transplantation) instrument and the QLQ-C30 (European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire) at day 180. Prespecified secondary outcomes included day 100 QOL and 1-year overall survival.

RESULTS

A total of 302 participants (median [range] age, 63 [20-79] years; 117 [38.7%] females; 185 [61.3%] males) were included in the analysis; 152 were randomized to shared care and 150 to usual care. Day 100 NRM was noninferior for shared vs usual care (2.6% [95% CI, 0.7% to 6.6%] vs 2.7% [95% CI, 0.7% to 6.7%]; P = .98). There were no differences at day 180 for the FACT-BMT total score (mean difference, 3.8; 95% CI, -2.1 to 9.6; P = .20) or QLQ-C30 global score (1.9; 95% CI, -4.9 to 8.8; P = .58). At day 100, the FACT-BMT total score was better for shared care (mean difference, 6.6; 95% CI, 1.0 to 12.1; P = .02) as was the QLQ-C30 global score (8.8; 95% CI, 1.8 to 15.7; P = .02).

CONCLUSIONS AND RELEVANCE

This randomized clinical trial found that shared care resulted in noninferior NRM at day 100 but similar QOL at day 180, with improved QOL at day 100. These data suggest that shared care is safe, improves QOL early on, and has the potential to become a routine model for post-HCT care.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03244826.