CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 110 enrolled / 110 target
Drug / intervention
Behavioral, Psychological or Informational Intervention +8 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02079662
NCT02079662N/AActiveOn Track (0.7/mo)
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Integrative Oncology Program in Improving Cancer-Related Outcomes in Patients With Stage II or III Breast Cancer Undergoing Radiation Therapy

M.D. Anderson Cancer Center·interventional·Posted Mar 6, 2014·Updated Jun 11, 2026

In Brief

A clinical study evaluating Behavioral, Psychological or Informational Intervention, Best Practice, and 7 other interventions for Stage II Breast Cancer AJCC v6 and v7 and 6 related conditions. Active but no longer recruiting, targeting 110 participants across 1 site.

Detailed Summary

This randomized clinical trial studies an integrative oncology (making changes in lifestyle and behavior) program in improving cancer-related outcomes in patients with stage II or III breast cancer undergoing radiation therapy. An integrative oncology program consisting of dietary recommendations, physical activity, stress management, social support, and control of environmental contaminants may modify cancer-related biological processes, influence long-term treatment results, and improve the quality of life of patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

N/AActive
2013201420152016201720182019202020212022202320242025202620272028202920302031
First PostedMar 6, 2014
Enrollment StartJun 13, 2013
Primary CompletionDec 31, 2030
TodayJul 1, 2026
Enrollment to primary: 17.6 yearsPosted 12.3 years agoPrimary completion in 4.5 years

Arms & Interventions

Arm I (IO interventions)experimental

Patients undergo up to 7 different IO intervention sessions per week during their 6-week course of radiotherapy for between 1 and 3 hours each session, in addition to, up to 6 aerobic training sessions per week and one grocery store trip during the course of the program. IO intervention programs consist of nutritional coaching, behavioral therapy, yoga and meditation practice, resistance training, and a weekly meal sharing and cooking class. Patients then have weekly meetings with the study psychologist on the computer for 6 months, followed by a monthly meeting on the computer from 6-12 months, and 2 hour meetings at all follow-up appointments during the first year after radiotherapy.

Other: Behavioral, Psychological or Informational InterventionOther: Cognitive InterventionOther: Computer-Assisted InterventionOther: CounselingBehavioral: Exercise InterventionOther: Laboratory Biomarker AnalysisOther: Quality-of-Life AssessmentOther: Questionnaire Administration
Arm II (standard of care)active_comparator

Patients undergo standard of care.

Other: Best PracticeOther: Laboratory Biomarker AnalysisOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Behavioral, Psychological or Informational Interventionother

Undergo IO intervention

Best Practiceother

Undergo standard of care

Cognitive Interventionother

Undergo IO intervention

Computer-Assisted Interventionother

Undergo IO intervention

Counselingother

Undergo counseling

Exercise Interventionbehavioral

Undergo IO intervention

Laboratory Biomarker Analysisother

Correlative studies

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies