Melanoma Clinical Trial

M-POWER Feasibility Study

Summary

The purpose of this study is to test a new weight loss intervention designed for cancer survivors who have heart disease or cardiometabolic conditions. The investigators want to determine whether this study is feasible and acceptable to participants. The investigators also want to learn more about how cancer survivors take their medications.

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Full Description

The purpose of this study is to test a new weight loss intervention designed for cancer survivors. The investigators want to determine whether this approach to weight loss is feasible and acceptable to cancer survivors. All participants in the study will receive free behavioral telephone-based weight loss management in the Department of Preventive Medicine at Northwestern University. Participants must be willing and able to use their smartphone with Bluetooth and their WiFi to download Apps, set up a Fitbit account and a Google account if not already set up. Participants will use their smartphone to record food intake & physical activity over an 8 week weight loss program. This program includes recruitment of a "Buddy" that the participant will choose to support you during the 8 week study.

All participants will be asked to download a study application to use to record dietary intake each day during a "Run-In Week.". Eligible participants will then receive an 8-week weight loss program, including individual weekly sessions with health coaches. The investigators will also ask participants to complete both a baseline and follow-up session with study staff. If permitted by current university policies, these sessions will be held at the offices on Northwestern University's Chicago campus. Otherwise, these sessions will be conducted remotely via Zoom videoconference. If this is the case, as a privacy safeguard, the waiting room feature will be applied so that study staff can control who is admitted into the meeting. We expect that the participants will be in this research study for about 10 weeks.

The primary risk of participation is muscle soreness or injury from increased physical activity, as well as feelings of hunger from making changes to diet. The main benefit is that a participant may experience positive changes to their health and mood based on the study.

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Eligibility Criteria

Inclusion Criteria:

Cancer survivors between ages 18 and 84
BMI between ≥25 - 45 kg/m2
<350 lbs.; weight stable (no loss or gain >15 lbs. for the past 3 months)
Own a smartphone (Android or iOS) and web camera, be willing to install the M-POWER App
Will voluntarily provide informed consent
Reside in the Chicagoland area for the duration of their participation (i.e., 3 months)
Maintain at-home internet and WiFi service for the entirety of their participation
Cancer survivors with a history of breast cancer (up to stage IIIa), melanoma (up to stage IIb), prostate cancer (up to stage IIIb) or colorectal cancer (up to stage IIIa).

Exclusion Criteria:

Inability to speak and read English

Unstable medical conditions

Uncontrolled hypertension
Diabetes - uncontrolled or treated with insulin
Uncontrolled hypothyroidism
Unstable angina pectoris
Transient ischemic attack
Cancer undergoing active treatment (< 3 months since most recent surgery, chemotherapy, or radiation treatment for cancer)
Cerebrovascular accident or myocardial infarction within the past six months, Crohn's disease)
Pregnancy, lactation or intended pregnancy
Active suicidal ideation
Anorexia
Bulimia
Binge eating disorder
Requiring an assistive device for mobility, or those with any current condition that may limit or prevent participation in moderate physical activity
Upcoming reconstructive surgery scheduled to take place during the study period and/or < 3months have elapsed since reconstructive surgery
Substance abuse or dependence besides nicotine dependence
Active treatment of the primary cancer
Individuals that have ever had bariatric (or LapBand surgery)

Study is for people with:

Melanoma

Estimated Enrollment:

60

Study ID:

NCT05921565

Recruitment Status:

Active, not recruiting

Sponsor:

Northwestern University

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There is 1 Location for this study

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Northwestern University
Chicago Illinois, 60611, United States

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Study is for people with:

Melanoma

Estimated Enrollment:

60

Study ID:

NCT05921565

Recruitment Status:

Active, not recruiting

Sponsor:


Northwestern University

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