Clinical trial · Interventional
Exercise and Healthy Diet or Standard Care in Patients in Remission From Stage I or Stage II Endometrial Cancer
Survivors of Uterine Cancer Empowered By Exercise and Healthy Diet (SUCCEED)
NCT00732173CI-TRIAL-00009368completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| behavioral dietary intervention | Behavioral | — | UNRESOLVED |
| counseling intervention | Other | — | UNRESOLVED |
| educational intervention | Other | — | UNRESOLVED |
| exercise intervention | Behavioral | — | UNRESOLVED |
| survey administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Behavioral: behavioral dietary intervention
- Behavioral: exercise intervention
- Other: counseling intervention
- Other: educational intervention
- Other: survey administration
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Patients receive usual care informational brochures but no lifestyle counseling related to weight loss, physical activity, and nutrition.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDvon 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 21173649