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Clinical Trials/NCT06745180
NCT06745180
Recruiting
Not Applicable

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

University of Tennessee2 sites in 1 country260 target enrollmentJanuary 27, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
University of Tennessee
Enrollment
260
Locations
2
Primary Endpoint
Physical Activity (patient reported outcome)
Status
Recruiting
Last Updated
7 months ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
January 27, 2025
End Date
March 31, 2028
Last Updated
7 months ago
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Responsible Party
Sponsor

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)

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

Outcomes

Primary Outcomes

Physical Activity (patient reported outcome)

Time Frame: From Baseline to 15 Month Assessment

Participants will wear motion sensor on waist for 7 days

Secondary Outcomes

  • 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.)

Study Sites (2)

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