Clinical trial · Observational
Outpatient Health Care Program for Older Patients Receiving Chemotherapy for Newly Diagnosed Breast Cancer or Colon Cancer
A Randomized Controlled Trial of Outpatient Geriatric Evaluation and Management Among Older Patients With Breast and Colon Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No accrual
Summary
Brief summary (as posted)
RATIONALE: Gathering health information from older patients undergoing chemotherapy may help doctors plan better treatment and improve the quality of life for these patients. PURPOSE: This randomized clinical trial is studying how well an outpatient health care program works for older patients receiving chemotherapy for newly diagnosed breast cancer or colon cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cognitive/Functional Effects | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Psychosocial Effects of Cancer and Its Treatment | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| chemotherapy | Drug | Chemotherapy | ALIAS |
| cognitive assessment | Procedure | — | UNRESOLVED |
| medical chart review | Other | — | UNRESOLVED |
| psychosocial assessment and care | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Chemotherapy tolerability as measured by dose reduction, treatment delay, and incidence of grade 3-5 toxicities
Secondary outcomes (3)
- measure
- Mean change in comprehensive geriatric assessment scores and quality-of-life scores from baseline to post-chemotherapy and from baseline to 12 months following randomization
- measure
- Number of emergency room visits, acute hospitalizations, and associated Medicare costs within the first 12 months following randomization
- measure
- 3-year disease-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma, including one of the following:
* Breast cancer (female), meeting the following criteria:
* Stage I-III (T1-4, N0-3, M0) disease
* Has undergone complete surgical removal of invasive cancer by mastectomy or lumpectomy
* Has undergone either sentinel lymph node dissection or axillary lymph node dissection with adequate TNM staging
* Colon cancer (male or female), meeting the following criteria:
* Stage I-III (T1-3, any N, M0) disease
* Has undergone appropriate surgical resection with TNM staging
* Newly diagnosed disease
* Scheduled to receive chemotherapy
* Agrees to receive chemotherapy AND is able to receive chemotherapy within 3 months after surgery
* No distant metastases
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* Life expectancy ≥ 6 months
* Fluent in English
* Not living in a nursing home
* No end-stage disease
* No severe dementia
* No other clinically active malignancy within the past 5 years or within 3 months after diagnosis of current malignancy
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy for the malignancy
* More than 1 year since prior treatment on an inpatient/outpatient geriatric evaluation and management unitReferences
Publications (0)
Data not yet available