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NCT01441011 · ClinicalTrials.gov registry record · NA

Rural Women Connecting for Better Health

A NA study, sponsored by University of Kansas Medical Center.

Completed
Registry status
NA
Development phase
210
Enrollment target

NCT01441011: Completed NA study, sponsored by University of Kansas Medical Center.

NCT01441011 is a NA study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 210 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01441011, a NA study, has completed, sponsored by University of Kansas Medical Center.

COMPLETED
Registry status
NA
Development phase
210 participants
Enrollment target

Study Summary

Women who are obese at breast cancer diagnosis have a 1.5 to 2.5 increased risk of recurrence and death compared to their normal weight counterparts. Moreover, weight gain and decreased physical activity are common after diagnosis and also increase the likelihood of breast cancer recurrence and death. Rural women suffer from health disparities in breast cancer diagnosis and treatment. Women of the most rural counties also have the highest prevalence of obesity compared to urban women. To address these disparities, the overarching objective of this proposal is to develop a clinically effective and cost efficient strategy for delivering a weight control intervention to rural breast cancer survivors. Group phone-based treatment via conference call is a novel treatment delivery approach that the investigators have shown to be effective for initial weight loss among rural breast cancer survivors and more effective than the standard individual phone-based approach among rural women. This innovative method of providing group treatment addresses access barriers in rural areas and may be especially ideal for rural breast cancer survivors because it provides social support in conjunction with a level of anonymity. However, the impact of group phone counseling during extended care for weight loss maintenance beyond 6 months remains unknown. Weight loss maintenance is the more challenging phase of treatment when weight regain is common, and this regain presents a potential risk for breast cancer recurrence. This randomized controlled trial will evaluate the effects of group phone-based treatment for weight loss maintenance among rural breast cancer survivors, compared to an established mail-based education comparison condition, subsequent to a 6 month group phone-based weight loss phase for both conditions. In addition to the intervention impact on weight loss maintenance, the study will provide estimates of incremental cost-effectiveness per kg loss between the two conditions

Primary Outcome

Examine the impact of group phone-based treatment on weight loss maintenance from 6 to 18 months, compared to a mail-based education COMPARISON condition, following a 6-month weight loss phase among obese rural breast cancer survivors.

Interventions

  • BEHAVIORAL Group phone counseling
  • BEHAVIORAL Newsletter

Trial Details

FieldValue
Enrollment Target 210 participants
Start Date 2011-08
Est. Completion 2015-10
Phase NA
University of Kansas Medical Center

408 total trials

What the finished NCT01441011 record still lists

NCT01441011 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 2 interventions - of which Group phone counseling is the first listed.

NCT01441011 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01441011 about?

NCT01441011 is a clinical study titled "Rural Women Connecting for Better Health". Women who are obese at breast cancer diagnosis have a 1.5 to 2.5 increased risk of recurrence and death compared to their normal weight counterparts. Moreover, weight gain and decreased physical activity are common after diagnosis and also increase the likelihood of breast cancer recurrence and deat...

What is the current status of trial NCT01441011?

This trial is currently completed. It is a NA study. The enrollment target is 210 participants. The study started on 2011-08. Estimated completion is 2015-10.

What interventions are being tested in trial NCT01441011?

The interventions under investigation include: Group phone counseling (BEHAVIORAL), Newsletter (BEHAVIORAL).

Who is sponsoring clinical trial NCT01441011?

This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01441011's enrollment target sits among peer trials

210 490th of 2000 higher than 1,505 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 NCT01441011, the US trial registry maintained by the National Library of Medicine. NCT01441011 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.