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The purpose of this study is to test a psycho-educational intervention, Managing Cancer Care: A Personal Guide (MCC), that is intended to improve patients' knowledge of palliative care and to facilitate its timely integration into self-management of their breast cancer. The MCC will be tested with patients with Stage I-IV breast cancer at baseline, one, and three months following enrollment. The intervention group will receive the MCC, and the attention-control group will receive a symptom management toolkit. Participants' family caregivers will also be enrolled to provide information on patients' self-management. Investigators hypothesize that users of MCC, as compared to attention-control participants, will demonstrate improved knowledge, feelings, and behaviors related to self-management of their cancer care. This innovative research can help to establish palliative care as a mainstay of self-management interventions that target serious illnesses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Management Group | Experimental | Managing Cancer Care: A Personal Guide (MCC) is a set of magazine-format, printed modules that includes information about key self-management topics, worksheets, "conversation starters", and targeted links to local and internet resources, among other features. |
|
| Symptom Management Group | Active Comparator | Participants in the Symptom Management Group will be given a symptom management toolkit that provides information on the most commonly experienced symptoms and side effects of cancer treatment, including fatigue, nausea, and sleep problems, among others. Each chapter includes information on when and why the symptom may occur, how the symptom can be managed, and when to call a provider. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-Management Group | Behavioral |
| ||
| Symptom Management Group |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge of Care Options Test | 1 month | |
| Knowledge of Care Options Test | 3 months | |
| Knowledge of Care Options Test | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Control Preferences Scale | 1 month | |
| Medical Communication Competence Scale | 1 month | |
| Measurement of Transitions Scale |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dena Schulman-Green, PhD | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale-New Haven Hospital | New Haven | Connecticut | 06510 | United States | ||
| Yale School of Nursing |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27107680 | Derived | Schulman-Green D, Linsky S, Jeon S, Kapo J, Blatt L, Chagpar A. Integrating palliative care into self-management of breast cancer: Protocol for a pilot randomized controlled trial. Contemp Clin Trials. 2016 May;48:133-8. doi: 10.1016/j.cct.2016.04.009. Epub 2016 Apr 20. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Behavioral |
|
| 1 month |
| Chronic Disease Self-Efficacy Scale | 1 month |
| Hospital Anxiety and Depression Scale | 1 month |
| Uncertainty in Illness Scale | 1 month |
| Health Care Utilization Form | 3 months |
| Goals of Care Conversations Form | 1 month |
| Control Preferences Scale | 3 months |
| Medical Communication Competence Scale | 3 months |
| Measurement of Transitions Scale | 3 months |
| Chronic Disease Self-Efficacy Scale | 3 months |
| Hospital Anxiety and Depression Scale | 3 months |
| Uncertainty in Illness Scale | 3 months |
| Goals of Care Conversations Form | 3 months |
| Control Preferences Scale | baseline |
| Medical Communication Competence Scale | baseline |
| Measurement of Transitions Scale | baseline |
| Chronic Disease Self-Efficacy Scale | baseline |
| Hospital Anxiety and Depression Scale | baseline |
| Uncertainty in Illness Scale | baseline |
| Goals of Care Conversations Form | baseline |
| West Haven |
| Connecticut |
| 06516 |
| United States |
| D017437 |
| Skin and Connective Tissue Diseases |