This clinical trial assesses how integrative medicine at home (IM@Home) improves patient perceived values, outcomes, and experiences as they undergo cancer treatment for head and neck cancer, lung cancer, gynecological cancer, melanoma, or breast cancer. The IM@Home program offers virtual (online rather than in-person) group classes focusing on mind-body practice. Mind-body practice is a health practice that combines mental focus, controlled breathing, and body movements to help relax the body and mind. The IM@Home classes range from movement-based therapies (fitness, yoga, dance therapy, or tai chi) to meditative therapies (meditation, guided meditation, or music therapy). IM@Home may help to reduce patients’ symptoms (such as tiredness, pain, or insomnia) and improve their satisfaction with treatment for their disease.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05053230.
PRIMARY OBJECTIVE:
I. To evaluate the effect of IM@Home intervention on symptoms, oncology treatment adherence, and health care utilization among oncology patients undergoing active systemic treatment.
SECONDARY OBJECTIVE:
I. To identify the specific factors (e.g., socio-demographic, clinical, or symptom) associated with IM@Home engagement and satisfaction among oncology patients undergoing active systemic treatment.
TERTIARY OBJECTIVE:
I. To understand patients’ experiences, perceived values, and identify opportunities for further refinement of IM@Home program in specific tumor groups for further development and testing.
EXPLORATORY OBJECTIVE:
I. To evaluate if timing of patient recruitment, during active treatment versus (vs.) within four weeks of finishing radiation treatment, impacts the rate of trial enrollment and participation in the IM@Home program among women with breast cancer. (Breast basket only)
II. To evaluate the effect of IM@Home intervention on symptom burden and health care utilization among gynecologic cancer patients who have completed first line treatment. (First Remission Gynecologic Cancer basket only)
III. To evaluate the effect of IM@Home intervention on symptom burden in cancer survivors who have completed active therapy. (Cancer Survivors basket only)
IV. To evaluate the effect of IM@Home intervention on healthcare utilization, symptoms, oncology treatment adherence, and overall survival in patients living with advanced cancer. (Advanced Cancer basket only)
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients attend IM@Home session including a series of virtual, synchronous classes that offer a variety of rigorously tested mind-body therapies for up to 30-45 minutes weekly over 12 weeks.
GROUP II: Patients receive enhanced usual care over 12 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorKarolina Lucja Bryl