This clinical trial compares standard care to a tailored care intervention (Oncology-Primary Care Partnership to Improve Comprehensive Survivorship Care [OPTIMISE]) for the supportive care of stage I-IIIB breast, stage I-III gastrointestinal, or stage I-III hematologic cancer patients with additional diseases (comorbidities). OPTIMISE is a tailored care intervention involving care coordination, action planning, reminders and follow-up, structured communication with providers, and community resource linkages. OPTIMISE may be more effective at providing supportive care to cancer patients than the current standard of care.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05323409.
Locations matching your search criteria
United States
Texas
Houston
Ben Taub General HospitalStatus: Active
Contact: Hoda Badr
Phone: 713-798-1588
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterStatus: Active
Contact: Hoda Badr
Phone: 713-798-1588
PRIMARY OBJECTIVES:
I. Assess the impact of OPTIMISE on patient chronic disease self-management and quality of life (QOL). (Aim 1A)
II. Explore the effects of OPTIMISE on healthcare use and unmet needs during and after cancer directed treatment. (Aim 1B)
III. Examine the effects of OPTIMISE on oncologist and primary care providers (PCP) attitudes and coordination of care. (Aim 2)
IV. Elucidate patient- and system-level factors that influence OPTIMISE implementation outcomes. (Aim 3)
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive usual medical care. Patients receive cancer treatment, as directed by their oncologist, a survivorship care plan (SCP) at the end of active treatment, and surveillance visits with their oncologist based on national guidelines.
ARM II: Patients receive the OPTIMISE program. OPTIMISE consists of 1) An oncology nurse navigator assigned to the patient's care team at diagnosis to facilitate oncologist-PCP communication and continuity of care; 2) Coordinated care between the patient's oncologist and PCP throughout cancer treatment and surveillance facilitated by a structured communication and referral process; 3) An SCP at the end of treatment that incorporates comorbidity management; and, 4) A risk-stratified shared care model of post-treatment surveillance where one or more routine oncologist follow- up visits is replaced by a PCP visit.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorHoda Badr