Clinical trial NCT05053230: A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer
Official title: Integrative Medicine for Patient-reported Outcomes, Values, and Experience (IMPROVE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Head and Neck Tumor
Thoracic Tumor
Thoracic Cancer
Gynecologic Cancer
Gynecologic Tumor
Melanoma
Ovarian Cancer
Keywords: Head and Neck Cancer
head and neck tumor
thoracic tumors
gynecological tumors
melanoma
21-369
Memorial Sloan Kettering Cancer Center
ovarian cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overarching long-term goal of the Integrative Medicine for Patient-reported Outcomes Values and Experience (IMPROVE) research program is to evaluate whether integrating a virtual mind-body programming, Integrative Medicine at Home (IM@Home), will improve patient perceived values, outcomes, and experiences as they undergo systemic cancer treatment such as chemotherapy, immunotherapy, radiotherapy, targeted agents, cytoreductive surgery.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years or older
* Karnofsky score 60 or greater
* Life expectancy greater than six months
* English speaking

Additional Inclusion Criteria for 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
* Actively receiving systemic oncological treatment or radiotherapy, or within 4 weeks of radiotherapy completion or primary cytoreductive surgery
* Worst fatigue over the last 7 days rated 4 or greater on (0-10 scale)

Additional Inclusion Criteria for First Remission Gynecologic Cancer Basket

* Patients with a diagnosis or clinical suspicion of gynecologic malignancy who have completed definitive first line treatment (maintenance hormonal or targeted therapies are allowed)

Additional Inclusion Criteria for the 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
* Actively receiving oncological treatment, radiotherapy or active surveillance

Additional Inclusion Criteria for the Cancer Survivor Basket:

* Completed active cancer treatment (e.g., surgery, radiation, chemotherapy) (maintenance hormonal or targeted therapies are allowed).
* 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

Primary outcomes:
measure: Average Fatigue Severity from the Brief Fatigue Inventory (BFI)
timeFrame: 12 weeks
Secondary outcomes:
measure: Symptom intensity as measured by Edmonton Symptom Assessment Scale (ESAS)
timeFrame: 12 weeks
measure: Insomnia severity as measured by Insomnia Severity Index (ISI)
timeFrame: 12 weeks
measure: Effect of treatments on psychological distress as measured by Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 weeks
measure: Pain as measured by Patient Reported Outcomes Measurement Information System (PROMIS®) Scale v1.2 - Global Health
timeFrame: 12 weeks
measure: Participants treatment outcome expectancy as measured by Mao Expectancy of Treatment Effects (METE)
timeFrame: 12 weeks
measure: Satisfaction of intervention
timeFrame: 12 weeks
measure: Recommendation of Intervention to Others
timeFrame: 12 weeks
measure: Number of Treatment Disruptions
timeFrame: 12 weeks
measure: Number of Unplanned medical visits
timeFrame: 12 weeks
measure: Participant Attendance to IM@Home Sessions
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jun Mao, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: