This clinical trial compares a behavioral coaching intervention (Laguna Health) to usual care for promoting recovery, improving quality of life, and reducing hospital readmissions in cancer patients who have been discharged from the hospital. Patients who have been hospitalized with cancer often experience a high symptom burden and are at high risk for hospital readmission. However, supportive care interventions to promote post-hospital discharge recovery for these patients are limited. The Laguna Health intervention connects patients to recovery coaches that help them understand their post-discharge treatment plan, identify social and emotional barriers to recovery, and connect them to resources to overcome those barriers. In addition to having a recovery coach, patients have access to digital health and recovery information via the Laguna Health platform, including their personal medication list, their discharge instructions, and articles and videos about symptoms and how to manage them. This trial may help researchers understand whether the Laguna Health intervention is better at improving the experience of cancer patients who are recovering from a recent hospitalization, compared to usual care.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06004141.
PRIMARY OBJECTIVES:
I. To examine the feasibility of Laguna Health for patients with cancer who are discharged from the hospital.
II. To examine the acceptability of Laguna Health for patients with cancer who are discharged from the hospital.
III. To examine the acceptability of Laguna Health for caregivers of patients with cancer who are discharged from the hospital.
IV. To explore the preliminary efficacy of Laguna Health for improving patient reported quality of life (QOL), symptom burden, psychological distress, as well as caregiver QOL and caregiving burden.
V. To explore the effect of Laguna Health on patient healthcare utilization up to six months after enrollment.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive access to the Laguna Health application (app) intervention for 12 weeks following the patient's discharge from the hospital. A Laguna Health coach meets with participants digitally twice during week 1, at least once per week during weeks 2, 3, and 4, and then as-needed in weeks 5-12. Participants may engage with other Laguna Health app activities (To Dos, journaling, daily logs, and chats/texts with coaches) and content per their own preference for 12 weeks on study.
ARM II: Participants receive usual post-discharge care for 12 weeks on study.
After completion of study intervention, patients are followed up at 24 weeks post-discharge from the hospital.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorTejaswini More Dhawale
