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Integrative Medicine at Home (IM@Home) for Cancer (IMPROVE Trial)

N/A
Recruiting
Led By Jun Mao, MD, MSCE
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Worst fatigue over the last 7 days rated 4 or greater on (0-10 scale)
Patients with a diagnosis of head and neck tumors, thoracic tumors, gynecological tumors, melanoma, or breast cancer
Must not have
Cognitive impairment that would preclude response to study assessments or require the use of Legally Authorized Representatives
Unwilling to accept random assignment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether the IM@Home program can help reduce patients' symptoms and improve their satisfaction with treatment for their disease.

Who is the study for?
This trial is for adults over 18 with certain cancers (like head and neck, lung, gynecologic, or melanoma) who are currently undergoing treatment or have recently finished radiotherapy. They should be experiencing fatigue and have a life expectancy of more than six months. Participants must speak English and not have cognitive impairments that affect communication.
What is being tested?
The study is testing the IM@Home program to see if it can ease symptoms like tiredness, pain, or sleep issues in cancer patients. It involves virtual group classes that use mind-body practices such as mental focus exercises, controlled breathing, and body movements.
What are the potential side effects?
Since IM@Home is a non-invasive program focusing on relaxation techniques rather than medication or surgery, significant side effects are not expected. However, participants may experience varying levels of comfort with the activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have experienced significant fatigue, rating it 4 or higher in the past week.
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I have been diagnosed with cancer in my head, neck, chest, reproductive organs, skin, or breast.
Select...
I am currently undergoing cancer treatment or finished radiotherapy within the last 4 weeks.
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I am able to care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am mentally capable of understanding and responding to study assessments without needing a legal representative.
Select...
I am not open to being randomly assigned to a treatment group.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average Fatigue Severity from the Brief Fatigue Inventory (BFI)
Secondary study objectives
Effect of treatments on psychological distress as measured by Hospital Anxiety and Depression Scale (HADS)
Insomnia severity as measured by Insomnia Severity Index (ISI)
Number of Treatment Disruptions
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: IM@HomeExperimental Treatment1 Intervention
Participants with head and neck tumors, thoracic tumors, gynecological tumors, melanoma, breast cancer, or ovarian cancer
Group II: Enhanced usual careExperimental Treatment1 Intervention
Participants with head and neck tumors, thoracic tumors, gynecological tumors, melanoma, breast cancer, or ovarian cancer
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enhanced usual care
2017
Completed Phase 4
~11570

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,083 Total Patients Enrolled
Jun Mao, MD, MSCEPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
9 Previous Clinical Trials
1,830 Total Patients Enrolled

Media Library

Enhanced usual care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05053230 — N/A
~50 spots leftby Sep 2025
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