This clinical trial compares informational support versus spiritual care to improve spiritual wellbeing for patients with lung or gastrointestinal cancer that is incurable or that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Patients who receive a cancer diagnosis may experience spiritual distress and spiritual struggle that can impact their quality of life and spiritual well-being. Religion and spirituality have been demonstrated to be an important resource for coping with cancer and can also affect medical decision making and treatment. The spiritual care intervention, consisting of visits with a trained chaplain, may be a feasible and acceptable method when compared to an informational support intervention, to improve spiritual wellbeing for patients with incurable or advanced lung or gastrointestinal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07176559.
Locations matching your search criteria
United States
Indiana
Carmel
IU Health North HospitalStatus: Active
Contact: Alexia M. Torke
Phone: 317-274-9221
Indianapolis
Indiana University/Melvin and Bren Simon Cancer CenterStatus: Active
Contact: Alexia M. Torke
Phone: 317-274-9221
Lafayette
IU Health Arnett Cancer CareStatus: Active
Contact: Alexia M. Torke
Phone: 317-274-9221
PRIMARY OBJECTIVES:
I. To evaluate the feasibility and acceptability of all aspects of the study, including randomization, delivery of the spiritual care assessment and intervention (SCAI) framework (e.g., chaplain intervention), attention control, and outcome assessments, in preparation for a larger, stage III effectiveness trial.
II. To test the effects of spiritual care on the outcome of spiritual wellbeing.
SECONDARY OBJECTIVE:
I. To test the effects of spiritual care based on the SCAI framework on the outcomes of anxiety, depression, and satisfaction with spiritual care.
TERTIARY OBJECTIVE:
I. To test the effects of spiritual care on hospice utilization within the year after enrollment and, among patients who die within one year, on life-sustaining treatments within 30 days of the end of life.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive visits with a chaplain to discuss meaning and purpose, relationships, transcendence and peace, self-worth and identity over approximately 30 minutes per week depending on patient availability or preference for 4 visits over 3 months.
ARM II: Patients receive educational visits with a social worker and receive education about the medical center and treatment team, financial challenges and resources, evaluating heath information and cancer related resources over approximately 30 minutes per week depending on patient availability or preference for 4 visits over 3 months.
After completion of study treatment, patients are followed up at 7-14 days, 6-8 weeks, 12-14 weeks and 1 year.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorAlexia M. Torke
