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A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer (IMPROVE)

Primary Purpose

Head and Neck Cancer, Head and Neck Tumor, Thoracic Tumor

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IM@Home
Enhanced usual care
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Head and Neck Cancer, head and neck tumor, thoracic tumors, gynecological tumors, melanoma, 21-369, Memorial Sloan Kettering Cancer Center

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years or older
  • Patients with a diagnosis of head and neck tumors, thoracic tumors, gynecological tumors, melanoma, or breast cancer
  • Actively receiving systemic oncological treatment or radiotherapy
  • Worst fatigue over the last 7 days rated 4 or greater on (0-10 scale)
  • Karnofsky score 60 or greater
  • Life expectancy greater than six months
  • English speaking

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

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IM@Home

Enhanced usual care

Arm Description

Participants with head and neck tumors, thoracic tumors, gynecological tumors, melanoma, or breast cancer

Participants with head and neck tumors, thoracic tumors, gynecological tumors, melanoma, or breast cancer

Outcomes

Primary Outcome Measures

Average Fatigue Severity from the Brief Fatigue Inventory (BFI)
Primary outcome will be measured by the average fatigue severity measured by the Brief Fatigue Inventory (BFI). The BFI is a 9-item instrument designed to assess one construct of fatigue severity in cancer and non-cancer populations. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items are measured on a 0-10 scale, with 0 being "does not interfere" and 10 being "completely interferes."59 A composite fatigue severity score can be found by averaging the 9 item scores.

Secondary Outcome Measures

Full Information

First Posted
September 20, 2021
Last Updated
October 2, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05053230
Brief Title
A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer
Acronym
IMPROVE
Official Title
Integrative Medicine for Patient-reported Outcomes, Values, and Experience (IMPROVE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
September 20, 2024 (Anticipated)
Study Completion Date
September 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to find out whether the Integrative Medicine at Home (IM@Home) program can help reduce patients' symptoms (such as tiredness, pain, or insomnia) and improve their satisfaction with treatment for their disease. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Head and Neck Tumor, Thoracic Tumor, Thoracic Cancer, Gynecologic Cancer, Gynecologic Tumor, Melanoma
Keywords
Head and Neck Cancer, head and neck tumor, thoracic tumors, gynecological tumors, melanoma, 21-369, Memorial Sloan Kettering Cancer Center

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IM@Home
Arm Type
Experimental
Arm Description
Participants with head and neck tumors, thoracic tumors, gynecological tumors, melanoma, or breast cancer
Arm Title
Enhanced usual care
Arm Type
Placebo Comparator
Arm Description
Participants with head and neck tumors, thoracic tumors, gynecological tumors, melanoma, or breast cancer
Intervention Type
Behavioral
Intervention Name(s)
IM@Home
Intervention Description
Participants will be enrolled into either IM@Home or enhanced usual care for the study duration of 12 weeks. IM@Home is an online mind-body program consisted of a series of virtual, synchronous classes that offer a variety of rigorously tested mind-body therapies led by an Integrative Medicine Service (IMS) clinical therapist. The virtual mind-body group therapy sessions will be conducted using Zoom video conferencing platform.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced usual care
Intervention Description
Patients in the enhanced usual care will receive usual care. In addition, once enrolling into the trial, they will be given a handout to encourage them to visit the MSK's multimedia page on the Integrative Medicine website to access pre-recorded, on-demand meditation videos/audios
Primary Outcome Measure Information:
Title
Average Fatigue Severity from the Brief Fatigue Inventory (BFI)
Description
Primary outcome will be measured by the average fatigue severity measured by the Brief Fatigue Inventory (BFI). The BFI is a 9-item instrument designed to assess one construct of fatigue severity in cancer and non-cancer populations. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items are measured on a 0-10 scale, with 0 being "does not interfere" and 10 being "completely interferes."59 A composite fatigue severity score can be found by averaging the 9 item scores.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years or older Patients with a diagnosis of head and neck tumors, thoracic tumors, gynecological tumors, melanoma, or breast cancer Actively receiving systemic oncological treatment or radiotherapy, or within 4 weeks of radiotherapy completion Worst fatigue over the last 7 days rated 4 or greater on (0-10 scale) Karnofsky score 60 or greater Life expectancy greater than six months English speaking 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Mao, MD, MSCE
Phone
646-888-0863
Email
maoj@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Tony Hung, MD
Phone
646-608-4127
Email
HungT@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-888-0863
Facility Name
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-888-0863
Facility Name
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-888-0863
Facility Name
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-888-0863
Facility Name
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-888-0863
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-888-0863
Facility Name
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-888-0863

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer

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