Clinical trial · Interventional
Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer
A Biobehavioral Intervention for Patients With Gynecologic or Breast Cancer Recurrence
NCT01764789CI-TRIAL-00019407completedN/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 pilot clinical trial studies stress reduction in improving quality of life in patients with recurrent gynecologic or breast cancer. Participating in a stress reduction program may help improve quality of life in patients with gynecologic or breast cancer.
Conditions
Conditions (20)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety Disorder | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Leydig Cell Tumor | Leydig Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Ovarian Sarcoma | Ovarian Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Stromal Cancer | Malignant Ovarian Epithelial Tumor | ALIAS | 0.90 |
| Pain | — | UNRESOLVED | — |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
| Pseudomyxoma Peritonei | Pseudomyxoma Peritonei | ONTOLOGY_EXACT | 0.98 |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| behavioral intervention | Behavioral | — | UNRESOLVED |
| cognitive intervention | Other | — | UNRESOLVED |
| educational intervention | Other | — | UNRESOLVED |
| psychosocial assessment and care | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (psychosocial intervention)
- description
- Patients participate in a multi-component intervention based on cognitive and behavioral principles comprising MBSR, an intervention to promote hopefulness, and a problem solving approach which navigates around obstacles or generates alternatives when goals become blocked. Additional topics may be covered as indicated by clinical need and patients goals. Biobehavioral components include addressing social and disease-specific quality of life, and pain education. Intensive treatment sessions continue weekly for 16 weeks followed by 2 biweekly and 2 monthly maintenance sessions.
- interventionNames
- Other: questionnaire administration
- Procedure: quality-of-life assessment
- Procedure: psychosocial assessment and care
- Behavioral: behavioral intervention
- Other: cognitive intervention
- Other: educational intervention
Primary outcomes (1)
- measure
- Quality of life(QoL)
- timeFrame
- up to 28 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of recurrent breast or gynecologic cancer (any site) with any disease-free interval; second primary cancers do not meet this criterion * English speaking * Able and willing to give informed consent * To be considered for the blood and saliva collection, women must fulfill the following secondary criteria: * Diagnosis of recurrent breast or ovarian cancer with any disease-free interval Exclusion Criteria: * Residence \> 70 miles from research site * Subnormal intellectual potential (diagnosis of mental retardation) * Progressive neurological or chronic, progressive, debilitating condition (e.g., dementia) * Non-ambulatory * Life expectancy less than 160 days, per the treating oncologist * Current suicide risk sufficient to preclude treatment on an outpatient basis * Chronic inflammatory or autoimmune disorder (e.g., rheumatoid arthritis, lupus)
References
Publications (0)
Data not yet available
No reference posted for this study.