Making Healthy Habits Stick
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19+
SponsorUniversity of Tennessee
About this trial
The aim of this project is to help increase physical activity maintenance in cancer survivors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Factorial
Treatments tested in this trial
Short Message System (SMS)
BehavioralThe Short Message System (SMS) intervention focuses on personalized, adaptive SMS messages that help the participant maintain physical activity behaviors.
Peer Coach
BehavioralThe peer coach will deliver an intervention that will help participants maintain physical activity.
Usual Care
BehavioralParticipants will be given written materials providing advice on maintaining their physical activity.
Peer Coach and SMS
BehavioralThe 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.
Treatment groups
260 Participants
are divided into 4 treatment groupsGroup A: Peer Coach and SMSExperimental treatment 1 intervention
Group B: Peer CoachExperimental treatment 1 intervention
Group C: Short Message Service (SMS)Experimental treatment 1 intervention
Group D: Usual CareOther 1 intervention
Trial outcomes
Primary outcomes
1
Physical Activity (patient reported outcome)
Participants will wear motion sensor on waist for 7 days
Time frame
From Baseline to 15 Month AssessmentSecondary outcomes
1
Fatigue (Patient reported outcome)
Fatigue will be measured using the Fatigue Symptom Inventory (fatigue intensity and interference) scale.
Time frame
At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.2
Self-perceived Health (Patient reported outcome)
Self-perceived health will be measured using the EQ-5D questionnaire.
Time frame
At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.3
Qualify of life (Patient reported outcome)
Quality of life will be measured via the PROMIS Global Health questionnaire.
Time frame
At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.4
Anxiety & Depression (patient reported outcome)
Anxiety and depression will be measured using the Hospital Anxiety and Depression Scale.
Time frame
At Baseline, 3 month assessment, 9 month assessment, and 15 month assessment.Other outcomes
1
Stress (patient reported outcome)
Stress will be measured using the Perceived Stress Scale
Time frame
At Baseline, 3 months, 9 months, and 15 months2
Social Determinants of Health
Social determinants of health will be measured using the Social Determinants of Health (SDoH) questionnaire.
Time frame
At Baseline, 3 months, 9 months, 15 months3
Big Five Personality (patient reported outcome)
Big five personality will be measured using a brief version of the Big Five Personality Inventory questionnaire.
Time frame
At Baseline, 3 months, 9 months, 15 months4
Self-report Physical Activity
Aerobic and resistance exercise will be measured using the Godin Aerobic Strength questionnaire.
Time frame
At Baseline, 3 months, 9 months, 15 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Tennessee
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
University of Alabama at Birmingham
Collaborator
Source ClinicalTrials.gov