Clinical trial · Interventional
Telephone-Based Decision Support for Rural Patients
- 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)
The investigators community based resource center has implemented visit preparation by prompting patients to write down their questions. This is a proven approach to increasing the number of questions and concerns that patients voice during their visits with doctors. The resource center's usual practice is to provide their visit preparation intervention, called Consultation Planning, through in-person counseling sessions. This study asks whether telephone delivery of Consultation Planning would be almost as effective in terms of increasing patient's decision self-efficacy, or confidence in their ability to navigate decisions effectively with their physicians. The study also asks about the cost-effectiveness of telephone delivery compared to in-person delivery. The investigators are answering these questions through a randomized, controlled, non-inferiority trial with two arms: in-person versus telephone delivery of Consultation Planning. The investigators are measuring self-reported psychological outcomes such as decision self-efficacy (primary outcome), preparation for decision making, anxiety, and distress, along with economic outcomes such as health resource utilization and willingness to pay. The investigators hypothesize that Tele-CP can be delivered at a lower patient and resource center cost than in-person CP, and that it will be as effective in terms of impact on a patient's decisional self-efficacy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| In-person CP | Behavioral | — | UNRESOLVED |
| Tele-CP | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- In-person
- description
- Participants in this arm have been randomized to receive Consultation Planning in-person
- interventionNames
- Behavioral: In-person CP
- type
- ACTIVE_COMPARATOR
- label
- Telephone
- description
- Participants in this arm have been randomized to receive Consultation Planning by telephone.
- interventionNames
- Behavioral: Tele-CP
Primary outcomes (2)
- measure
- Decisional Self-Efficacy (DSE)
- timeFrame
- -1 hour (1 hour prior to intervention)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Females age 18 or older * Diagnosis of Ductal Carcinoma in Situ (DCIS) or local recurrence of DCIS * New (stage 1, 2, 3, 4) invasive breast cancer or recurrence * Upcoming appointment to see a surgeon or oncologist to discuss treatment options * Surgeons or oncologists whom the patient is consulting * Able to speak, read, and understand English or Spanish Exclusion Criteria: * Females less than 18 years of age * Males with breast cancer * Females with breast cancer who are also pregnant (pregnancy changes the breast cancer treatment) * Clients who are determined to have "diminished mental capacity" according to the standards of the CRCMC Policy on Mental Competence
References
Publications (1)
- RESULTBelkora J, Stupar L, O'Donnell S, Loucks A, Moore D, Jupiter C, Johnson N, Wilson L. Decision support by telephone: randomized controlled trial in a rural community setting. Patient Educ Couns. 2012 Oct;89(1):134-42. doi: 10.1016/j.pec.2012.06.009. Epub 2012 Jul 7. PMID 22776761