NCT00732173

Brief Summary

RATIONALE: Participating in a diet and exercise program may improve the quality of life of overweight and obese patients who are in remission from endometrial cancer. PURPOSE: This randomized phase I trial is studying an exercise and healthy diet program to see how well it works compared with standard care in patients in remission from stage I or stage II endometrial cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2008

Typical duration for not_applicable

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, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

1.7 years

First QC Date

August 8, 2008

Last Update Submit

February 7, 2013

Conditions

Endometrial Cancer

Keywords

stage I endometrial carcinomastage II endometrial carcinoma

Outcome Measures

Primary Outcomes (1)

  • Weight change

    Analysis will be carried out by fitting a mixed model. Weight change will be expressed in terms of absolute and relative weight change. In addition, percent weight change will be calculated. To test the null hypotheses that the groups do not differ in terms of change in weight at 6 or 12 months, parameter estimates from the model will be used to construct subsequent t-test that the difference in means at 3, 6, or 12 months is zero.

    at baseline and 3, 6, and 12 months.

Secondary Outcomes (7)

  • Quantitative and qualitative nutrient intake

    at baseline and 3, 6, and 12 months.

  • Minutes spent in moderate and vigorous physical activity

    at baseline and 3, 6, and 12 months.

  • Body composition, using dual energy x-ray absorptiometry/densitometry (DEXA) methodology

    at baseline and 3, 6, and 12 months.

  • Biomarkers for metabolic syndrome and nutrition

    at baseline and 3, 6, and 12 months.

  • Self-efficacy

    at baseline and 3, 6, and 12 months.

  • +2 more secondary outcomes

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive a lifestyle intervention, "Survivors of Uterine Cancer Empowered by Exercise and Healthy Diet (SUCCEED)", on a group and individual basis consisting of nutrition, exercise, and behavioral modification counseling from a physician, psychologist, registered dietitian, and physical therapist. Sixteen group sessions will be conducted (10 weekly, 6 bi-weekly) for 6 months. Weight and body mass index, satisfaction with study treatment, and exercise/activity logs are assessed weekly and biweekly. Patients receive additional feedback and support during the weeks not met in a group, including newsletters and telephone and e-mail contact.

Behavioral: behavioral dietary interventionBehavioral: exercise interventionOther: counseling interventionOther: educational interventionOther: survey administration

Arm II

ACTIVE COMPARATOR

Patients receive usual care informational brochures but no lifestyle counseling related to weight loss, physical activity, and nutrition.

Other: educational intervention

Interventions

behavioral dietary interventionBEHAVIORAL

Undergo SUCCEED lifestyle intervention

Arm I
exercise interventionBEHAVIORAL

Undergo SUCCEED lifestyle intervention

Arm I
counseling interventionOTHER

Undergo SUCCEED lifestyle intervention

Arm I
educational interventionOTHER

Receive information

Arm IArm II
survey administrationOTHER

Undergo SUCCEED lifestyle intervention

Arm I

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed stage I or II (early) endometrial carcinoma * Diagnosed within the past 3 years * Underwent prior surgery consisting of a total abdominal hysterectomy and bilateral salpingo-oophorectomy * No evidence of disease PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * BMI ≥ 25 (overweight/obese) * Medical clearance from primary care physician * Approved for contact by treating gynecologic oncologist * At least a 6th-grade reading level to complete significant reading and homework * No severe psychiatric illness (e.g., schizophrenia, bipolar disorder) or major depression (Beck Depression Inventory \> 29) that needs more aggressive, problem-focused interventions * No dementia or cognitive deficits * No pre-existing medical conditions that would be a barrier for participation in unsupervised walking * No participation in a structured weight loss or exercise program in the past 6 months * Must agree to and be available for longitudinal follow-up assessments * Non-English speakers may bring an English-speaking person to all group sessions and visits PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Related Publications (1)

  • von Gruenigen VE, Waggoner SE, Frasure HE, Kavanagh MB, Janata JW, Rose PG, Courneya KS, Lerner E. Lifestyle challenges in endometrial cancer survivorship. Obstet Gynecol. 2011 Jan;117(1):93-100. doi: 10.1097/AOG.0b013e31820205b3.

    PMID: 21173649DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

CounselingEarly Intervention, Educational

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesChild Health ServicesPreventive Health Services

Study Officials

  • Peter G. Rose, MD

    Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

  • Vivian von Gruenigen, MD

    Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2008

First Posted

August 11, 2008

Study Start

July 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2011

Last Updated

February 8, 2013

Record last verified: 2013-02

Locations

US(1)