This clinical trial evaluates a mindfulness-based intervention (Integrative Therapies bedside service) for improving symptom management in patients undergoing a stem cell transplant for hematologic malignancies. Stem cell transplant after chemotherapy is one of the most effective treatment options for patients with hematologic malignancies. However, patients may experience a decline in their health-related quality of life after transplant, which may be related to an increase in symptoms such as distress, anxiety, and depression. Holistic services such as integrative medicine techniques may be effective at managing common symptoms and side effects such as pain, nausea, and anxiety. The Integrative Therapies bedside service offers mindfulness-based interventions including meditation, relaxation techniques, and massage therapy at the bedside. This bedside service may improve symptom management in patients undergoing a stem cell transplant for their cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04185428.
PRIMARY OBJECTIVES:
I. Describe study feasibility, based on (a) the proportion agreeing to participate in Integrative Therapy’s inpatient program, the (b) proportion of participants who complete at least 3 intervention sessions, (c) the distribution of intervention sessions provided, and (d) distribution of missing data.
II. Describe acceptability of offering an Integrative Therapies bedside service as a complementary intervention for symptom management in this population based on the distribution of responses to an acceptability questionnaire.
SECONDARY OBJECTIVES:
I. Compare the symptoms burden and health-related quality of life (HRQoL) between the two cohorts (intervention and standard of care).
II. Describe patient perceptions of their symptoms and experiences with integrative therapy using qualitative interviews.
III. Describe facilitators and barriers to participating in an Integrative Therapies bedside service through a qualitative review of patient interviews.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients receive Integrative Therapies bedside sessions including still meditation, meditative movement, relaxation techniques, and/or massage therapy 2 to 3 times per week in addition to standard care for the duration of their hospital stay.
GROUP II: Patients receive standard care for the duration of their hospital stay.
After completion of their stem cell transplant, patients are followed up at 30 days.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUF Health Cancer Institute - Gainesville
Principal InvestigatorNosha Farhadfar
