This clinical trial compares the use of a telehealth delivered psychosocial intervention, called ENGAGE, to telehealth supportive care for improving symptom management in patients with breast, prostate, lung or colorectal cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Pain, fatigue, and distress are highly prevalent, co-occurring, and persistent symptoms in patients with advanced (i.e., likely incurable) solid tumor cancer. Psychosocial symptom management interventions, such as ENGAGE, are specifically designed to decrease symptom interference through the development of coping skills and mindfulness, for patients living with advanced cancer. ENGAGE may work better for improving symptom management, when compared to telehealth supportive care in patients with advanced breast, prostate, lung or colorectal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06555588.
Locations matching your search criteria
United States
North Carolina
Durham
Duke University Medical CenterStatus: Active
Contact: Joseph G. Winger
Phone: 919-416-7506
PRIMARY OBJECTIVES:
I. To determine the efficacy of ENGAGE for reducing the primary outcome of symptom interference.
II. To determine the efficacy of ENGAGE for improving secondary outcomes.
III. To test the maintenance of ENGAGE’s effects.
EXPLORATORY OBJECTIVE:
I. To prepare for wide-spread implementation of the ENGAGE protocol by conducting an implementation-related process evaluation.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients complete telehealth cognitive behavioral therapy and acceptance and commitment therapy sessions, over 45 minutes, for 4 session over 4-8 weeks. Patients receive a workbook and other materials. Participants without access to the internet and/or videoconferencing technology will be loaned a study iPad with a data plan.
ARM II: Patients complete supportive care sessions, about common symptoms and resources to address those symptoms, over 45 minutes, for 4 session over 4-8 weeks. Patients receive a workbook and other materials. Participants without access to the internet and/or videoconferencing technology will be loaned a study iPad with a data plan.
After completion of study intervention, patients are followed up at 2 and 4 months from randomization.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDuke University Medical Center
Principal InvestigatorJoseph G. Winger
