Making Healthy Habits Stick

NCT ID: NCT06745180

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-27

Study Completion Date

2028-03-31

Brief Summary

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The aim of this project is to help increase physical activity maintenance in cancer survivors.

Detailed Description

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The purpose of the study is to evaluate novel interventions designed to assist women cancer survivors, who identify as African American or Black, in overcoming exercise barriers, developing a physically active mindset, and establishing exercise habits needed to exercise long term. These novel interventions are 1. Text Messaging (SMS), 2. Peer Coaching, 3. Combination of Peer Coaching and SMS, 4. Usual Care

Conditions

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Cancer Physical Activity Cancer Survivor Cancer Survivorship

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

2x2 Factorial Design
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Peer Coach and SMS

SMS and peer coach interventions focused on physical activity maintenance

Group Type EXPERIMENTAL

Peer Coach and SMS

Intervention Type BEHAVIORAL

The Short Message System (SMS) intervention focuses on personalized, adaptive SMS messages that help the participant maintain physical activity behaviors. The peer coach will deliver an intervention that will help participants maintain physical activity.

Peer Coach

Peer coach intervention focused on physical activity maintenance

Group Type EXPERIMENTAL

Peer Coach

Intervention Type BEHAVIORAL

The peer coach will deliver an intervention that will help participants maintain physical activity.

Short Message Service (SMS)

SMS intervention focused on physical activity maintenance

Group Type EXPERIMENTAL

Short Message System (SMS)

Intervention Type BEHAVIORAL

The Short Message System (SMS) intervention focuses on personalized, adaptive SMS messages that help the participant maintain physical activity behaviors.

Usual Care

Written materials focused on physical activity maintenance

Group Type OTHER

Usual Care

Intervention Type BEHAVIORAL

Participants will be given written materials providing advice on maintaining their physical activity.

Interventions

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Short Message System (SMS)

The Short Message System (SMS) intervention focuses on personalized, adaptive SMS messages that help the participant maintain physical activity behaviors.

Intervention Type BEHAVIORAL

Peer Coach

The peer coach will deliver an intervention that will help participants maintain physical activity.

Intervention Type BEHAVIORAL

Usual Care

Participants will be given written materials providing advice on maintaining their physical activity.

Intervention Type BEHAVIORAL

Peer Coach and SMS

The Short Message System (SMS) intervention focuses on personalized, adaptive SMS messages that help the participant maintain physical activity behaviors. The peer coach will deliver an intervention that will help participants maintain physical activity.

Intervention Type BEHAVIORAL

Other Intervention Names

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SMS Short Message Service Peer Support Peer Sustainability

Eligibility Criteria

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Inclusion Criteria

* woman age of 19 or older
* identifies as African American or Black
* have a history of cancer
* have completed post-primary treatment for cancer (i.e., chemotherapy, radiation)
* agree to allow research team to confirm cancer diagnosis with your physician
* If received surgery, must be at least 8 weeks post-surgery
* willing to have regular physician provide medical clearance for study participation
* willing to provide home address if qualified for the study
* willing and able to use videoconference platform such as Zoom for study activities (must be both willing and able)
* willing and able to send and/or receive text messages (must be both willing and able)
* has US phone number
* has an email address
* if has no email address, must be willing to create one
* English speaking
* Able to ambulate without assistance (does not need to use a cane, a walker, or a wheelchair)
* willing and able to complete 3-5 exercise session per week on their own for the duration of the study; if answered no, please explain
* willing to attend individual and group sessions via videoconferences during study participation; if answered no, please explain.
* willing to attend assessments via videoconference during study participation; if answered no, please explain.
* willing to complete surveys during study participation; if answered no, please explain.

Exclusion Criteria

* Metastatic or recurrent cancer
* another cancer diagnosis in the past 5 years (not including skin or cervical cancer in situ)
* have severe orthopedic, joints or any other condition that stops individual from being active
* unstable angina
* have paint, tightness, or heaviness in chest EITHER when resting OR then physically active
* have New York Heart Association class II, III, OR IV congestive heart failure
* blood pressure has been over 160/100 at least twice in the past 6 months (either number; 160 or 100)
* have uncontrolled asthma
* have interstitial lung disease that requires extra oxygen
* have dementia or organize brain syndrome
* have schizophrenia or active psychosis
* have had a stroke or other problem that left individual disables or with paralysis (unable to move or feel any part of body)
* have hearing problems that make it hard to carry on a phone conversation
* blind or partially blind
* planned surgery during the first 6 month of study participation (if unapproved by PI)
* planned knee or hip surgery during the first 6 month of study participation
* anticipate changes in usual medications during the first 6 months of study participation (if unapproved by PI)
* have been told by a physician to only do exercise prescribed by a physician
* have been told by a physician to limit physical activity
* have a contraindication to engaging in moderate intensity aerobic exercise
* have completed on average, more than 90 min/week of moderate-intensity or more that 30 min/week of vigorous exercise in the past 6 months
* trouble with balance or moving around safely
* are currently pregnant or anticipate pregnant during study participation
* currently participating in another exercise study
* have BMI ≥ 50
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Martin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Laura Rogers, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

University of Tennessee Health Science Center

Memphis, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michelle Martin, PhD

Role: CONTACT

901-448-2383

Talia Williams, BA

Role: CONTACT

901-448-8682

Facility Contacts

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Laura Rogers, MD, MPH

Role: primary

205-934-9735

Ildiko Nyikos, MA, ACSM-RCEP, EIM-3

Role: backup

205-975-0002

Michelle Martin, PhD

Role: primary

901-448-2383

Talia Williams, BA

Role: backup

901-448-8682

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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R01MD018375

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-300011855

Identifier Type: -

Identifier Source: org_study_id

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