Clinical trial · Interventional
The Role of Lifestyle Factors in Breast Cancer-Related Outcomes
Integrative Oncology Program in Improving Cancer-Related Outcomes in Patients With Stage II or III Breast Cancer Undergoing Radiation Therapy
NCT02079662CI-TRIAL-00114350active not recruitingN/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)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IIA Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IIB Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage II Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IIIA Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral, Psychological or Informational Intervention | Other | — | UNRESOLVED |
| Best Practice | Other | — | UNRESOLVED |
| Cognitive Intervention | Other | — | UNRESOLVED |
| Computer-Assisted Intervention | Other | — | UNRESOLVED |
| Counseling | Other | — | UNRESOLVED |
| Exercise Intervention | Behavioral | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (IO interventions)
- description
- 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.
- interventionNames
- Other: Behavioral, Psychological or Informational Intervention
- Other: Cognitive Intervention
- Other: Computer-Assisted Intervention
- Other: Counseling
- Behavioral: Exercise Intervention
- Other: Laboratory Biomarker Analysis
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Arm II (standard of care)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women with stage II or III breast cancer that will be scheduled to undergo a 4 to 6-week course of radiotherapy * Participants must be able to read, write, and speak English * Participants must be oriented to person, place, and time * Participants must also meet at least two of the following criteria related to lifestyle: 1) consume less than 3 servings of fruit and vegetable/day; 2) engage in less than 75 minutes moderate/vigorous activity per week, defined as anything that causes small increases in breathing or heart rate for a sustained amount of time (e.g., brisk walking, bicycling); and 3) engage in a mind-body practice less than 4 times a month * Participants must have a body mass index (BMI) of 24.45 or higher as assessed in the medical record Exclusion Criteria: * Patients with a recurrent breast cancer diagnosis * Patients with another primary cancer diagnosis within 5 years of consent, not including non-melanoma skin cancers * Patients who have any major psychiatric diagnoses or thought disorder (e.g. schizophrenia, bi-polar disorder, dementia) * Patients with communication barriers (e.g., hard of hearing) * Patients with extreme mobility issues (e.g. unable to get in and out of a chair unassisted) * Patients with poorly or uncontrolled diabetes in the opinion of the physician(s)
References
Publications (0)
Data not yet available
No reference posted for this study.