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NCT02677857 · ClinicalTrials.gov registry record · NA

Developing a Healthy Lifestyle in Breast Cancer Survivors

A NA study, sponsored by The University of Tennessee, Knoxville.

Terminated
Registry status
NA
Development phase
7
Enrollment target

NCT02677857: Clinical Trial NA study, sponsored by The University of Tennessee, Knoxville.

NCT02677857 is a NA study that was terminated before completion, run by The University of Tennessee, Knoxville. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02677857, a NA study, was terminated before completion, sponsored by The University of Tennessee, Knoxville.

TERMINATED
Registry status
NA
Development phase
7 participants
Enrollment target

Study Summary

At this time, no study has examined the effect of a lifestyle intervention with a reduced Sedentary Behavior (SB) prescription on overall physical activity, weight loss, metabolic dysfunction, and inflammation in breast cancer survivors. Thus, in collaboration with University of Tennessee Medical Center's (UTMC) Cancer Institute, investigators propose to randomize 30 female breast cancer survivors (history of breast cancer stages I \[\> 1 cm\], II, or III) with a body mass index (BMI) between 25 and 45 kg/m2 who are sedentary (engage in \> 8 hours a day of SB) and inactive (engage in \< 100 min/wk MVPA) to one of three, 3-month conditions: 1. lifestyle intervention (Lifestyle) (increase MVPA to \> 200 min/wk); 2. lifestyle intervention with a reduced SB prescription (Lifestyle+SB) (increase MVPA to \> 200 min/wk and reduce SB by 2 hrs/day); or 3. weight management education materials provided via mailed newsletter (Newsletter). Lifestyle and Lifestyle+SB will receive a standard dietary (low-calorie \[1200-1500 kcal/day\], low-fat \[\<30% calories from fat\]) prescription that emphasizes intake of fruits, vegetables, and whole grains, and a cognitive behavioral intervention to assist with meeting activity and diet goals. Dependent variables, measured at 0 and 3 months, include objectively measured SB, LPA, MVPA, and total activity via accelerometry; self-reported SB; percent weight loss; insulin and glucose, and leptin and C-reactive protein (CRP) (biomarkers of cancer prognosis that have been found to be positively related to SB and/or adiposity); diet; body composition; and fitness.

Primary Outcome

Participants will wear the SenseWear Armband (SWA) for data collection of time spent engaging in physical activity per day.

Interventions

  • BEHAVIORAL Common intervention components for Lifestyle

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2016-01
Est. Completion 2016-12
Phase NA

Why NCT02677857 stopped before completion

NCT02677857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which Common intervention components for Lifestyle is the first listed.

NCT02677857 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02677857 about?

NCT02677857 is a clinical study titled "Developing a Healthy Lifestyle in Breast Cancer Survivors". At this time, no study has examined the effect of a lifestyle intervention with a reduced Sedentary Behavior (SB) prescription on overall physical activity, weight loss, metabolic dysfunction, and inflammation in breast cancer survivors. Thus, in collaboration with University of Tennessee Medical Ce...

What is the current status of trial NCT02677857?

This trial is currently terminated. It is a NA study. The enrollment target is 7 participants. The study started on 2016-01. Estimated completion is 2016-12.

What interventions are being tested in trial NCT02677857?

The interventions under investigation include: Common intervention components for Lifestyle (BEHAVIORAL).

Who is sponsoring clinical trial NCT02677857?

This trial is sponsored by The University of Tennessee, Knoxville, which has 81 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02677857's enrollment target sits among peer trials

7 1982nd of 2000 higher than 18 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02677857, the US trial registry maintained by the National Library of Medicine. NCT02677857 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.