NCT01166672

Brief Summary

The purpose of this study is to establish feasiblity of recruiting obese breast cancer survivors at the end of treatment, getting those survivors to lose weight and attend follow-up visits for 6 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 12, 2012

Status Verified

October 1, 2012

Enrollment Period

2.3 years

First QC Date

July 20, 2010

Last Update Submit

October 11, 2012

Conditions

ObesityBreast Cancer

Keywords

obese women (BMI greater than or equal to 30), do not already have a diagnosis of lymphedema, who are donewith surgery, chemotherapy, and radiation therapy, and who were diagnosed with breast cancer within thepast 2 years will be invited to participate.

Outcome Measures

Primary Outcomes (1)

  • Follow-up Appts.

    The primary outcome will be the precent of participants who complete 6 month follow-up appointments.

    6 months

Secondary Outcomes (1)

  • Response Rates

    6 months

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women, aged 18-70, who are obese (BMI greater than or equal to 30), do not already have a diagnosis of lymphedema, who are done with surgery, chemotherapy, and radiation therapy, and who were diagnosed with breast cancer within the past 2 years will be invited to participate.

You may qualify if:

  • Women
  • Breast Cancer Survivors who had 5 or more lymph nodes removed and radiation to lymph nodes as part of treatment.
  • Completed all treatments - no metastatic cancers
  • Overweight or obese (BMI greater than or equal to 25 kg/m2)
  • Medically and logistically able to participate in a weight loss and exercise program over 6 months.
  • Diagnosed with breast cancer within the past 2 years.

You may not qualify if:

  • More than 2 years since breast cancer diagnosis
  • Medical status that would preclude safety of participation in a weight loss and exercise program
  • Metastatic cancer
  • Already enrolled in a weight loss program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

ObesityBreast Neoplasms

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2010

First Posted

July 21, 2010

Study Start

July 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 12, 2012

Record last verified: 2012-10

Locations

US(1)