Exercise and diet education and instruction for Gynecologic Cancers

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rutgers, Cancer Institute of New Jersey, New Brunswick, NJ
Gynecologic Cancers
Exercise and diet education and instruction - Behavioral
Eligibility
18+
Female
What conditions do you have?
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Study Summary

The main goal in this project is to develop and pilot test a 12-week multiple health behavior change (MHBC) intervention for feasibility and acceptability. The pilot study will be guided by Multiphase Optimization Strategy (MOST) framework, which uses highly efficient experiments to systematically test and compare intervention components' or component levels' individual and combined effects. The goal of the MOST framework is to balance effectiveness with affordability, sustainability, and efficiency.

Treatment Effectiveness

Study Objectives

3 Primary · 16 Secondary · Reporting Duration: Week 13

Baseline and Week 13
6-minute walk test (m)
Arm curl test (quantity)
Blood pressure
Body composition
Chair sit-to-stand (quantity)
Exercise Self-efficacy
Facilitators and impediments
Health-related Quality of Life
Healthy Dietary Practices
Height (m)
Height, weight, waist and hip circumference, and body composition
Outcome expectations
Physical activity (objective)
Physical activity (self-report)
Waist and hip circumferences (m)
Weight (kg)
Week 13
Acceptability
Participant attendance
Participant retention

Trial Safety

Trial Design

1 Treatment Group

Exercise and diet education and instruction
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Exercise and diet education and instruction · No Placebo Group · N/A

Exercise and diet education and instruction
Behavioral
Experimental Group · 1 Intervention: Exercise and diet education and instruction · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 13
Closest Location: Rutgers, Cancer Institute of New Jersey · New Brunswick, NJ
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N/AFirst Recorded Clinical Trial
1 TrialsResearching Gynecologic Cancers
0 CompletedClinical Trials

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
361 Previous Clinical Trials
60,157 Total Patients Enrolled
2 Trials studying Gynecologic Cancers
405 Patients Enrolled for Gynecologic Cancers
Angela J Fong, PhDPrincipal InvestigatorRutgers Cancer Institute of New Jersey

Eligibility Criteria

Age 18+ · Female Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are pregnant or have a child under 18 years old.
You have completed treatment within five years prior to study commencement and have not received hormonal replacement therapy.
You are not active, defined as engaging in < 150 minutes of moderate-to-vigorous physical activity per week.
You have a potential unhealthy diet, defined as consuming < 2.5 servings of fruits and vegetables per day, or fast foods more than once per week over the past month.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.