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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 is a NA study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 210 participants.
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
Interventions
- BEHAVIORAL Group phone counseling
- BEHAVIORAL Newsletter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2011-08 |
| Est. Completion | 2015-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01441011
The ClinicalTrials.gov registry entry for NCT01441011 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Kansas Medical Center, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Group phone counseling is the first listed.
NCT01441011 reports 0 study locations.
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.
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