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Behavioural Intervention
Mobile App for Lifestyle Changes in Cancer Survivors
N/A
Recruiting
Led By Erin M Coffman, MA
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a mobile app that helps young cancer survivors increase physical activity & improve their diet.
Who is the study for?
This trial is for young adult cancer survivors aged 18-39 who were diagnosed with invasive cancer between ages 15-39, are not currently very active or eating enough fruits and vegetables, have finished their main cancer treatments except maintenance therapy, and have no progressive disease. They must be able to use the internet weekly, speak English, and commit to being randomly assigned to any study group.
What is being tested?
The trial tests a mobile intervention combining physical activity guidance and diet quality improvement for young adult cancer survivors. It includes various combinations of lesson delivery (weekly or once), nutrition monitoring (red or green levels), supportive text messages (yes or no), and setting nutrition goals (yes or no).
What are the potential side effects?
Since this is a lifestyle intervention focusing on exercise and healthy eating rather than medication, typical drug side effects aren't expected. However, participants may experience general discomforts related to new exercise routines or dietary changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 weeks, 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Accrual rate
Participation rate
Retention rate at 3 months
Secondary study objectives
Acceptability of the intervention.
Adherence to diet self-monitoring
Adherence to physical activity monitoring.
+10 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
16Treatment groups
Experimental Treatment
Group I: Condition 9Experimental Treatment5 Interventions
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
Group II: Condition 8Experimental Treatment5 Interventions
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
Group III: Condition 7Experimental Treatment5 Interventions
Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
Group IV: Condition 6Experimental Treatment5 Interventions
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
Group V: Condition 5Experimental Treatment5 Interventions
Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
Group VI: Condition 4Experimental Treatment5 Interventions
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
Group VII: Condition 3Experimental Treatment5 Interventions
Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
Group VIII: Condition 2Experimental Treatment5 Interventions
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
Group IX: Condition 16Experimental Treatment5 Interventions
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
Group X: Condition 15Experimental Treatment5 Interventions
Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons
Group XI: Condition 14Experimental Treatment5 Interventions
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons
Group XII: Condition 13Experimental Treatment5 Interventions
Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons
Group XIII: Condition 12Experimental Treatment5 Interventions
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons
Group XIV: Condition 11Experimental Treatment5 Interventions
Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons
Group XV: Condition 10Experimental Treatment5 Interventions
Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons
Group XVI: Condition 1Experimental Treatment5 Interventions
Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Core
2017
Completed Early Phase 1
~1810
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Who is running the clinical trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
364 Previous Clinical Trials
92,284 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,937 Previous Clinical Trials
41,022,296 Total Patients Enrolled
Erin M Coffman, MAPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot walk for exercise due to health issues.I don't have health issues that would stop me from following an exercise program on my own.I have been diagnosed or treated for an eating disorder in the past.I have had a heart attack or stroke in the last 6 months.I was diagnosed with cancer between 15 and 39 years old.I have an email address or am willing to create one.I am between 18 and 39 years old.I've finished my main cancer treatment but may be on maintenance therapy.I am currently taking prescription medication for weight loss.I plan to undergo major surgery, like breast reconstruction, during the study.I have untreated high blood pressure, high cholesterol, or diabetes but have my doctor's approval.I am open to being assigned to any treatment group.I was diagnosed with cancer in the last 10 years and have no signs of worsening or new cancers.I have been diagnosed with a psychiatric condition or have had drug/alcohol dependency.
Research Study Groups:
This trial has the following groups:- Group 1: Condition 5
- Group 2: Condition 9
- Group 3: Condition 11
- Group 4: Condition 7
- Group 5: Condition 8
- Group 6: Condition 15
- Group 7: Condition 6
- Group 8: Condition 12
- Group 9: Condition 14
- Group 10: Condition 16
- Group 11: Condition 13
- Group 12: Condition 10
- Group 13: Condition 1
- Group 14: Condition 2
- Group 15: Condition 3
- Group 16: Condition 4
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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