Clinical trial · Interventional
Decision Support for Women With Breast 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): Lack of funds to continue and volunteer recruitment member left position
Summary
Brief summary (as posted)
Breast cancer is a common malignancy among women in the United States. There are a variety of treatment decisions that need to be made. This study has been developed after a review of the literature demonstrated that women with breast cancer are making decisions regarding complex therapy issues in a way that is not congruent with their decision-making control preference. Some patients want to be empowered with information so that they can actively participate in the decision making about their care; others want to rely on the recommendations made by the oncologist. This is important because patients who were not satisfied with their adjuvant treatment decision noted a negative effect on quality of life and self image. These patients had more difficulties with treatment side effects; including aches, hot flashes, pain, and mood alteration. In additions the Institute of Medicine recommended that patient centeredness be a key aim of health care organizations and that all patients be given the opportunity to exercise the degree of control they choose over health care decisions that affect them. It is hypothesized that women making decisions regarding adjuvant therapy who are supported to make decisions based on their preferred level of control will have positive psychological outcomes.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decision control preference scale | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lifestyle counseling
- description
- Decision control preference intervention
- interventionNames
- Behavioral: Decision control preference scale
Primary outcomes (2)
- measure
- Satisfaction with Decision at 24 hours
- timeFrame
- 24 hours after consultation
- description
- Satisfaction with Decision (SWD) scale: A 6 item tool with a 5-point Likert scale ranging from 1, "strongly disagree" to 5, "strongly agree", will be used to evaluate the patient's satisfaction with decision involvement by phone within 24 hours following the consultation and repeated 4 weeks later. This instrument is based on the Satisfaction with Decision Instrument of Holmes-Rovner. The SWD scale performed reliability, Cronbach's alpha = 0.86
- measure
- Satisfaction with Decision at 4 weeks
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women with early stage (Stage I and Stage II) breast cancer that are considering adjuvant therapy and are being evaluated at the Johns Hopkins Avon Foundation Breast Center. 2. Age 18 years and older. 3. Able to read and speak English. Exclusion Criteria: 1. Severe visual impairments that would make it difficult to read study instruments or inability to read. 2. Lack of capacity to provide informed consent to participate in the study. 3. Patients being seen for a second opinion. 4. Patients with a history of previous neoadjuvant chemotherapy. 5. Women who are pregnant.
References
Publications (6)
- BACKGROUNDDegner LF, Kristjanson LJ, Bowman D, Sloan JA, Carriere KC, O'Neil J, Bilodeau B, Watson P, Mueller B. Information needs and decisional preferences in women with breast cancer. JAMA. 1997 May 14;277(18):1485-92. PMID 9145723
- BACKGROUNDDegner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43. PMID 9505581
- BACKGROUNDHolmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, Padonu G, Talarczyk G. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Making. 1996 Jan-Mar;16(1):58-64. doi: 10.1177/0272989X9601600114. PMID 8717600
- BACKGROUNDLo SS, Mumby PB, Norton J, Rychlik K, Smerage J, Kash J, Chew HK, Gaynor ER, Hayes DF, Epstein A, Albain KS. Prospective multicenter study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selection. J Clin Oncol. 2010 Apr 1;28(10):1671-6. doi: 10.1200/JCO.2008.20.2119. Epub 2010 Jan 11. PMID 20065191
- BACKGROUNDHack TF, Degner LF, Watson P, Sinha L. Do patients benefit from participating in medical decision making? Longitudinal follow-up of women with breast cancer. Psychooncology. 2006 Jan;15(1):9-19. doi: 10.1002/pon.907. PMID 15669023
- BACKGROUNDShaha M, Cox CL, Talman K, Kelly D. Uncertainty in breast, prostate, and colorectal cancer: implications for supportive care. J Nurs Scholarsh. 2008;40(1):60-7. doi: 10.1111/j.1547-5069.2007.00207.x. PMID 18302593