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Integrative Medicine for the Improvement of Patient-Reported Outcomes, Values, and Experience
Trial Status: active
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.
Inclusion Criteria
Age >= 18 years or older
Karnofsky score 60 or greater
Life expectancy greater than six months
English speaking
HEAD AND NECK, THORACIC, GYNECOLOGIC, MELANOMA AND BREAST BASKETS: Patients with a diagnosis of head and neck tumors, thoracic tumors, gynecological tumors, melanoma, breast cancer, or gynecologic cancer
HEAD AND NECK, THORACIC, GYNECOLOGIC, MELANOMA AND BREAST BASKETS: Actively receiving systemic oncological treatment or radiotherapy, or within 4 weeks of radiotherapy completion
HEAD AND NECK, THORACIC, GYNECOLOGIC, MELANOMA AND BREAST BASKETS: Worst fatigue over the last 7 days rated 4 or greater on (0-10 scale)
FIRST REMISSION GYNECOLOGIC CANCER BASKET: Patients with a diagnosis of gynecologic malignancy who have completed definitive first line treatment (maintenance hormonal or targeted therapies are allowed). No evidence of progressive disease after definitive first line treatment
ADVANCED CANCER BASKET: Patients with a diagnosis of stage III or IV lung cancer; any stage pancreatic
cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary or peri-ampullary cancer, or other stage IV gastrointestinal cancer; stage III or IV ovarian or fallopian tube cancers or other stage IV gynecologic cancer; stage IV breast cancer; stage III testicular cancer or any stage IV genitourinary cancer; stage IV sarcoma; stage IV melanoma; stage IV endocrine cancer; lymphoma, myeloma, or Leukemia
ADVANCED CANCER BASKET: Actively receiving oncological treatment, radiotherapy or active surveillance
CANCER SURVIVOR BASKET: Patients with prior cancer diagnosis of any type or stage, who are free of oncological disease
CANCER SURVIVOR BASKET: Completed active cancer treatment (e.g., surgery, radiation, chemotherapy [maintenance hormonal or targeted therapies are allowed])
CANCER SURVIVOR BASKET: Worst fatigue over the last 7 days rated 4 or greater on (0-10 scale)
Exclusion Criteria
Cognitive impairment that would preclude response to study assessments or require the use of Legally Authorized Representatives
Unwilling to accept random assignment
Concurrently enroll onto ongoing competing trials of integrative medicine interventions with symptom/toxicity as primary outcome. Note, however, patient will be allowed to enroll on other therapeutic protocols
Additional locations may be listed on ClinicalTrials.gov for NCT05053230.
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