CancerHABITSNCT06745180
Making Healthy Habits Stick
A study testing Short Message System (SMS), Peer Coach and Peer Coach and SMS in people with Cancer and Physical Activity, run by University of Tennessee at 2 sites in United States.
Trial summary
The aim of this project is to help increase physical activity maintenance in cancer survivors. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Cancer, Physical Activity, Cancer Survivor
- What is being tested?
- Short Message System (SMS), Peer Coach and Peer Coach and SMS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jan 2025to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Laura Rogers, MD, MPH, 205-934-9735, lqrogers@uabmc.edu
Ildiko Nyikos, MA, ACSM-RCEP, EIM-3, 205-975-0002, inyikos@uabmc.edu
- Recruiting
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
Michelle Martin, PhD, 901-448-2383, mmart126@uthsc.edu
Talia Williams, BA, 901-448-8682, twill213@uthsc.edu
About this study
Official title: 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.
Read the 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
- Conditions
- Cancer, Physical Activity, Cancer Survivor, Cancer Survivorship
- Being tested
- Short Message System (SMS), Peer Coach, Usual Care, Peer Coach and SMS
- Keywords
- Physical Activity, Cancer, Cancer Survivor, Exercise, Cancer Survivorship
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Message System (SMS)Behavioural
Also called SMS, Short Message Service
The Short Message System (SMS) intervention focuses on personalized, adaptive SMS messages that help the participant maintain physical activity behaviors.
Peer CoachBehavioural
Also called Peer Support, Peer Sustainability
The peer coach will deliver an intervention that will help participants maintain physical activity.
Usual CareBehavioural
Participants will be given written materials providing advice on maintaining their physical activity.
Peer Coach and SMSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Peer Coach and SMS | Experimental | SMS and peer coach interventions focused on physical activity maintenance Receives: Behavioral: Peer Coach and SMS |
| Peer Coach | Experimental | Peer coach intervention focused on physical activity maintenance Receives: Behavioral: Peer Coach |
| Short Message Service (SMS) | Experimental | SMS intervention focused on physical activity maintenance Receives: Behavioral: Short Message System (SMS) |
| Usual Care | Other | Written materials focused on physical activity maintenance Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity (patient reported outcome)
Participants will wear motion sensor on waist for 7 days
Measured: From Baseline to 15 Month Assessment
Secondary outcomes (4)
Fatigue (Patient reported outcome)
Fatigue will be measured using the Fatigue Symptom Inventory (fatigue intensity and interference) scale.
Measured: At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.
Self-perceived Health (Patient reported outcome)
Self-perceived health will be measured using the EQ-5D questionnaire.
Measured: At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.
Qualify of life (Patient reported outcome)
Quality of life will be measured via the PROMIS Global Health questionnaire.
Measured: At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.
Anxiety & Depression (patient reported outcome)
Anxiety and depression will be measured using the Hospital Anxiety and Depression Scale.
Measured: At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start27 Jan 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 Factorial Design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Michelle Martin, PhD, Principal investigator, University of TennesseeLaura Rogers, MD, MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745180
- Sponsor's protocol ID
- IRB-300011855
- Other IDs
- R01MD018375
- Acronym
- HABITS
- Status last verified
- Sep 2025
- First submitted
- 17 Dec 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individuals interested in requesting IPD should contact the study PIs.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making Healthy Habits Stick: Extended Contact Interventions to Promote Long-Term Physical Activity in Cancer Survivors
- ClinicalTrials.gov ID
- NCT06745180
- Acronym / sponsor ID
- HABITS / IRB-300011855
- Conditions
- Cancer, Physical Activity, Cancer Survivor, Cancer Survivorship
- Keywords
- Physical Activity, Cancer, Cancer Survivor, Exercise, Cancer Survivorship
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), University of Alabama at Birmingham
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this project is to help increase physical activity maintenance in cancer survivors.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 2x2 Factorial Design
| Arm | Type | Receives |
|---|---|---|
| Peer Coach and SMS | Experimental | Behavioral: Peer Coach and SMSSMS and peer coach interventions focused on physical activity maintenance |
| Peer Coach | Experimental | Behavioral: Peer CoachPeer coach intervention focused on physical activity maintenance |
| Short Message Service (SMS) | Experimental | Behavioral: Short Message System (SMS)SMS intervention focused on physical activity maintenance |
| Usual Care | Other | Behavioral: Usual CareWritten materials focused on physical activity maintenance |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Message System (SMS)Also: SMS, Short Message ServiceThe Short Message System (SMS) intervention focuses on personalized, adaptive SMS messages that help the participant maintain physical activity behaviors. | Behavioural | Short Message Service (SMS) |
| Peer CoachAlso: Peer Support, Peer SustainabilityThe peer coach will deliver an intervention that will help participants maintain physical activity. | Behavioural | Peer Coach |
| Usual CareParticipants will be given written materials providing advice on maintaining their physical activity. | Behavioural | Usual Care |
| Peer Coach and SMSThe 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. | Behavioural | Peer Coach and SMS |
Primary outcome
Physical Activity (patient reported outcome)
Time frame: From Baseline to 15 Month Assessment
Participants will wear motion sensor on waist for 7 days
4 secondary outcomes
Fatigue (Patient reported outcome)
Time frame: 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.
Qualify of life (Patient reported outcome)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Yes. Individuals interested in requesting IPD should contact the study PIs.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Martin, PhD principal investigator
University of Tennessee
Laura Rogers, MD, MPH principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Message System (SMS), Peer Coach and Peer Coach and SMS in people with Cancer and Physical Activity, run by University of Tennessee at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Martin, PhD (901-448-2383, mmart126@uthsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (patient reported outcome) (time frame: From Baseline to 15 Month Assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025; AzTrials last refreshed its copy on 31 Oct 2026.