BOLSTER Intervention in Improving Quality of Life in Caregivers and Patients with Gynecologic or Gastrointestinal Cancer

PRIMARY OBJECTIVES:

I. Conduct a single-arm study to assess the feasibility and acceptability of the BOLSTER intervention. (Phase I)

II. To determine the feasibility and acceptability of randomizing patients and family caregivers to enhanced discharge planning (EDP) or BOLSTER. (Phase II)

III. To estimate outcome parameters (estimated by means, standard deviations, and proportions of 4-week measures) of future primary (days outside of a facility) and secondary (self-efficacy, quality of life, mental health, health care utilization, and survival) outcomes to inform the design of a larger multi-center RCT. (Phase II)

SECONDARY OBJECTIVE:

I. Assess the perceived efficacy of the BOLSTER intervention and estimate outcomes parameters for this population. (Phase I)

OUTLINE: This is a partially randomized trial.

ARM I: Patients and caregivers receive BOLSTER intervention consisting of longitudinal nursing support across care settings, smartphone-based symptom management application (app), print and web-based symptom management toolkit, and advance care planning. BOLSTER intervention includes 6 contacts with the study nurse over 4 weeks, starting with twice weekly for 2 weeks after discharge, and then taper over time to weekly.

Patients are randomized to 1 of 2 arms following run-in phase.

ARM II: Patients and caregivers receive BOLSTER intervention as in arm I. Patients and caregivers also receive transitional care planning (enhanced discharge planning) consisting of a summary of future appointments, medication reconciliation, notes on patient-provider communication, and exercise and nutrition advice prior to discharge. Transitional care planning also includes services for filling out an after-hospital care plan (AHCP) and a brief training session on symptom management with a study nurse.

ARM III: Patients and caregivers receive transitional care planning as in arm II.