Clinical trial · Interventional
Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer
NCT01811264CI-TRIAL-00028637completedN/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)
Through a patient participation aid (PPA) the investigators hope to improve the psychosocial well-being of women diagnosed with metastatic breast cancer by empowering them to be active participants in clinical encounters.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient-Participation Aid | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Participants will begin with a pre-visit structured interview to determine emotional and physical well-being, anxiety, depression, and self-efficacy. Then they will be helped through the Patient-Participation Aid (PPA) by the research assistant (RA). Then they will meet with their doctor while the visit is video-recorded. After they will complete a post-visit interview to see if there were any health decisions made, patients level of involvement, and doctor communication. Follow up phone interviews will be conducted at 1 week and 3 months to assess patients self-reported changes in well-being, anxiety, depression, and decision regret.
- interventionNames
- Behavioral: Patient-Participation Aid
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Participants will begin with a pre-visit structured interview to determine emotional and physical well-being, anxiety, depression, and self-efficacy. They will have their doctor's visit video recorded. After they will complete a post-visit interview to see if there were any health decisions made, patients level of involvement, and doctor communication.Follow up phone interviews will be conducted at 1 week and 3 months to assess patients self-reported changes in well-being, anxiety, depression, and decision regret.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * female patients with metastatic breast cancer seeing one of the study physicians at one of the identified study clinics * age 21 or older * having suspected progression of metastatic disease Exclusion Criteria: * patients with an uncorrectable hearing impairment or having limited English proficiency, as this would adversely affect their ability to communicate with the physician * patients with uncorrectable vision impairment, as this would make it impractical for the patient to read the intervention * patients too ill to meaningfully converse with the physician
References
Publications (0)
Data not yet available
No reference posted for this study.