Clinical trial NCT06745180: Making Healthy Habits Stick
Official title: Making Healthy Habits Stick: Extended Contact Interventions to Promote Long-Term Physical Activity in African American Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Physical Activity
Cancer Survivor
Cancer Survivorship
Keywords: Physical Activity
Cancer
Cancer Survivor
Exercise
Cancer Survivorship
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: University of Alabama at Birmingham
First posted: 2024-12-20
Enrollment: 260
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 Factorial Design
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this project is to help increase physical activity maintenance in cancer survivors who are more likely to experience health disparities and social disadvantages.

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

Eligibility criteria: 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

Primary outcomes:
measure: Physical Activity (patient reported outcome)
timeFrame: From Baseline to 15 Month Assessment
Secondary outcomes:
measure: Fatigue (Patient reported outcome)
timeFrame: At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.
measure: Self-perceived Health (Patient reported outcome)
timeFrame: At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.
measure: Qualify of life (Patient reported outcome)
timeFrame: At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.
measure: Anxiety & Depression (patient reported outcome)
timeFrame: At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.
Other outcomes:
measure: Stress (patient reported outcome)
timeFrame: At Baseline, 3 months, 9 months, and 15 months
measure: Social Determinants of Health
timeFrame: At Baseline, 3 months, 9 months, 15 months
measure: Big Five Personality (patient reported outcome)
timeFrame: At Baseline, 3 months, 9 months, 15 months
measure: Self-report Physical Activity
timeFrame: At Baseline, 3 months, 9 months, 15 months
measure: Quality of Life (patient reported outcome)
timeFrame: At Baseline, 3 months, 9 months, 15 months
measure: Social Support for Physical Activity (patient reported outcome)
timeFrame: At Baseline, 3 months, 9 months, 15 months
measure: Reflective, Regulatory, and Reflexive processes (patient reported outcome)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months
measure: Perceived Exercise Barriers Interference
timeFrame: At Baseline, 3 months, 9 months, 15 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Michelle Martin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Laura Rogers, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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