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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
No pre-existing medical conditions(s) that preclude adherence to an unsupervised exercise program including cardiovascular disease, congestive heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
Diagnosed with invasive cancer malignancy between the ages of 15-39 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 3 months
Awards & highlights

Study 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.Check my eligibility
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).See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I don't have health issues that would stop me from following an exercise program on my own.
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I was diagnosed with cancer between 15 and 39 years old.
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I am between 18 and 39 years old.
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I was diagnosed with cancer in the last 10 years and have no signs of worsening or new cancers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accrual rate
Participation rate
Retention rate at 3 months
Secondary outcome measures
Acceptability of the intervention.
Adherence to diet self-monitoring
Adherence to physical activity monitoring.
+10 more

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
~1180

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,252 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,243 Total Patients Enrolled
Erin M Coffman, MAPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Media Library

Core (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05887401 — N/A
Physical Activity Research Study Groups: Condition 6, Condition 7, Condition 15, Condition 8, Condition 5, Condition 9, Condition 12, Condition 11, Condition 14, Condition 16, Condition 13, Condition 10, Condition 1, Condition 2, Condition 3, Condition 4
Physical Activity Clinical Trial 2023: Core Highlights & Side Effects. Trial Name: NCT05887401 — N/A
Core (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05887401 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are additional participants being accepted for enrollment in this trial?

"Clinicaltrials.gov suggests that no further participants are being sought for this research, which was first posted on June 1st 2023 and last updated around the same time. Nevertheless, there are 3 thousand and seventy-four other medical studies seeking enrolment right now."

Answered by AI

What is the ambition of this clinical experiment?

"This clinical trial aims to measure the participation rate over a 6-month period of enrollment. Secondary objectives include tracking participants' adherence to physical activity monitoring, diet self-monitoring and their levels of moderate-to-vigorous physical activity by outfitting them with Fitbits for 7 days."

Answered by AI

Do I fulfill the criteria for taking part in this investigation?

"To be eligible for enrollment in this study, volunteers must be between 18 and 39 years of age with an active exercise regimen. The research team is aiming to recruit 80 participants within that criteria."

Answered by AI

Does this research encompass geriatric participants?

"This medical study seeks to enroll patients aged 18-39. Those looking for trials that include minors or seniors may find 416 and 2784 studies respectively, on clinicaltrials.gov."

Answered by AI
~11 spots leftby Jun 2024