Making Healthy Habits Stick

NCT06745180 | Recruiting DMC

• 2 other identifiers: IRB-300011855R01MD018375
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cancer; Physical Activity; Cancer Survivor; Cancer Survivorship

Keywords

Physical Activity; Cancer; Cancer Survivor; Exercise; Cancer Survivorship

Outcome Measures

Primary Outcomes (1)

• Physical Activity (patient reported outcome)

  Participants will wear motion sensor on waist for 7 days

  From Baseline to 15 Month Assessment

Secondary Outcomes (4)

• Fatigue (Patient reported outcome)

  At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.

• Self-perceived Health (Patient reported outcome)

  At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.

• Qualify of life (Patient reported outcome)

  At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.

• Anxiety & Depression (patient reported outcome)

  At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.

Other Outcomes (8)

• Stress (patient reported outcome)

  At Baseline, 3 months, 9 months, and 15 months

• Social Determinants of Health

  At Baseline, 3 months, 9 months, 15 months

• Big Five Personality (patient reported outcome)

  At Baseline, 3 months, 9 months, 15 months

Study Arms (4)

Peer Coach and SMS

EXPERIMENTAL

SMS and peer coach interventions focused on physical activity maintenance

Behavioral: Peer Coach and SMS

Peer Coach

EXPERIMENTAL

Peer coach intervention focused on physical activity maintenance

Behavioral: Peer Coach

Short Message Service (SMS)

EXPERIMENTAL

SMS intervention focused on physical activity maintenance

Behavioral: Short Message System (SMS)

Usual Care

OTHER

Written materials focused on physical activity maintenance

Behavioral: Usual Care

Interventions

Short Message System (SMS) BEHAVIORAL

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

Also known as: SMS, Short Message Service

Short Message Service (SMS)

Peer Coach BEHAVIORAL

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

Also known as: Peer Support, Peer Sustainability

Peer Coach

Usual Care BEHAVIORAL

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

Usual Care

Peer Coach and SMS 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 and SMS

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Tennessee: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Motor Activity

Interventions

Spermine Synthase

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Study Officials

• Michelle Martin, PhD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

• Laura Rogers, MD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Martin, PhD

CONTACT

901-448-2383; mmart126@uthsc.edu

Talia Williams, BA

CONTACT

901-448-8682; twill213@uthsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x2 Factorial Design

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: January 27, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: After data management is finalized (and data locked) and the manuscript reporting physical activity maintenance data at month 15 has been submitted
• Access Criteria: A data use agreement between the institution housing the data (UTHSC) and the institution of the requesting researcher will be required.

Locations

US (2)