Clinical trial NCT02148575: Integrating Palliative Care Into Self-Management of Breast Cancer
Official title: Integrating Palliative Care Into Self-Management of Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Palliative Care
Self-management
Breast Cancer
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 109
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Over the age of 21
* Stage I-IV breast cancer
* Live in the State of Connecticut
* Speak English
* Receiving any kind of treatment for breast cancer
* Prognosis of at least 6 months

Primary outcomes:
measure: Knowledge of Care Options Test
timeFrame: 1 month
measure: Knowledge of Care Options Test
timeFrame: 3 months
measure: Knowledge of Care Options Test
timeFrame: baseline
Secondary outcomes:
measure: Control Preferences Scale
timeFrame: 1 month
measure: Medical Communication Competence Scale
timeFrame: 1 month
measure: Measurement of Transitions Scale
timeFrame: 1 month
measure: Chronic Disease Self-Efficacy Scale
timeFrame: 1 month
measure: Hospital Anxiety and Depression Scale
timeFrame: 1 month
measure: Uncertainty in Illness Scale
timeFrame: 1 month
measure: Health Care Utilization Form
timeFrame: 3 months
measure: Goals of Care Conversations Form
timeFrame: 1 month
measure: Control Preferences Scale
timeFrame: 3 months
measure: Medical Communication Competence Scale
timeFrame: 3 months
measure: Measurement of Transitions Scale
timeFrame: 3 months
measure: Chronic Disease Self-Efficacy Scale
timeFrame: 3 months
measure: Hospital Anxiety and Depression Scale
timeFrame: 3 months
measure: Uncertainty in Illness Scale
timeFrame: 3 months
measure: Goals of Care Conversations Form
timeFrame: 3 months
measure: Control Preferences Scale
timeFrame: baseline
measure: Medical Communication Competence Scale
timeFrame: baseline
measure: Measurement of Transitions Scale
timeFrame: baseline
measure: Chronic Disease Self-Efficacy Scale
timeFrame: baseline
measure: Hospital Anxiety and Depression Scale
timeFrame: baseline
measure: Uncertainty in Illness Scale
timeFrame: baseline
measure: Goals of Care Conversations Form
timeFrame: baseline
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: West Haven
country: United States
facility: Yale School of Nursing
state: Connecticut
Study officials:
affiliation: Principal Investigator
name: Dena Schulman-Green, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.