Making Healthy Habits Stick (HABITS)

September 26, 2025 updated by: University of Tennessee

Making Healthy Habits Stick: Extended Contact Interventions to Promote Long-Term Physical Activity in Cancer Survivors

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
        • Contact:
          • Ildiko Nyikos, MA, ACSM-RCEP, EIM-3
          • Phone Number: 205-975-0002
          • Email: inyikos@uabmc.edu
        • Principal Investigator:
          • Laura Rogers, MD, MPH
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • Recruiting
        • University of Tennessee Health Science Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michelle Martin,, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peer Coach and SMS
SMS and peer coach interventions focused on physical activity maintenance
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.
Experimental: Peer Coach
Peer coach intervention focused on physical activity maintenance
Behavioral: Peer Coach
The peer coach will deliver an intervention that will help participants maintain physical activity.
Other Names:
  • Peer Support
  • Peer Sustainability
Experimental: Short Message Service (SMS)
SMS intervention focused on physical activity maintenance
Behavioral: Short Message System (SMS)
The Short Message System (SMS) intervention focuses on personalized, adaptive SMS messages that help the participant maintain physical activity behaviors.
Other Names:
  • SMS
  • Short Message Service
Other: Usual Care
Written materials focused on physical activity maintenance
Behavioral: Usual Care
Participants will be given written materials providing advice on maintaining their physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity (patient reported outcome)
Time Frame: From Baseline to 15 Month Assessment
Participants will wear motion sensor on waist for 7 days
From Baseline to 15 Month Assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue (Patient reported outcome)
Time Frame: At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.
Fatigue will be measured using the Fatigue Symptom Inventory (fatigue intensity and interference) scale.
At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.
Self-perceived Health (Patient reported outcome)
Time Frame: At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.
Self-perceived health will be measured using the EQ-5D questionnaire.
At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.
Qualify of life (Patient reported outcome)
Time Frame: At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.
Quality of life will be measured via the PROMIS Global Health questionnaire.
At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.
Anxiety & Depression (patient reported outcome)
Time Frame: At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.
Anxiety and depression will be measured using the Hospital Anxiety and Depression Scale.
At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress (patient reported outcome)
Time Frame: At Baseline, 3 months, 9 months, and 15 months
Stress will be measured using the Perceived Stress Scale
At Baseline, 3 months, 9 months, and 15 months
Social Determinants of Health
Time Frame: At Baseline, 3 months, 9 months, 15 months
Social determinants of health will be measured using the Social Determinants of Health (SDoH) questionnaire.
At Baseline, 3 months, 9 months, 15 months
Big Five Personality (patient reported outcome)
Time Frame: At Baseline, 3 months, 9 months, 15 months
Big five personality will be measured using a brief version of the Big Five Personality Inventory questionnaire.
At Baseline, 3 months, 9 months, 15 months
Self-report Physical Activity
Time Frame: At Baseline, 3 months, 9 months, 15 months
Aerobic and resistance exercise will be measured using the Godin Aerobic Strength questionnaire.
At Baseline, 3 months, 9 months, 15 months
Quality of Life (patient reported outcome)
Time Frame: At Baseline, 3 months, 9 months, 15 months
Quality of life will be measured using the EQ-5D-5L questionnaire.
At Baseline, 3 months, 9 months, 15 months
Social Support for Physical Activity (patient reported outcome)
Time Frame: At Baseline, 3 months, 9 months, 15 months
Social support for physical activity will be measured using the Social Support for PA questionnaire.
At Baseline, 3 months, 9 months, 15 months
Reflective, Regulatory, and Reflexive processes (patient reported outcome)
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
Reflective, regulatory, and reflexive processes is being measured by the M-PAC physical activity questionnaire.
Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
Perceived Exercise Barriers Interference
Time Frame: At Baseline, 3 months, 9 months, 15 months
Barriers to exercise will be measured using the Perceived Barriers to Exercise questionnaire.
At Baseline, 3 months, 9 months, 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Collaborators

University of Alabama at Birmingham
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Michelle Martin, PhD, University of Tennessee
  • Principal Investigator: Laura Rogers, MD, MPH, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

December 20, 2024

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 26, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300011855
  • R01MD018375 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individuals interested in requesting IPD should contact the study PIs.

IPD Sharing Time Frame

After data management is finalized (and data locked) and the manuscript reporting physical activity maintenance data at month 15 has been submitted

IPD Sharing Access Criteria

A data use agreement between the institution housing the data (UTHSC) and the institution of the requesting researcher will be required.

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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