NCT02148575

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 26, 2017

Status Verified

June 1, 2016

Enrollment Period

1.8 years

First QC Date

May 21, 2014

Last Update Submit

April 25, 2017

Conditions

Breast Cancer

Keywords

Palliative CareSelf-managementBreast Cancer

Outcome Measures

Primary Outcomes (3)

  • Knowledge of Care Options Test

    1 month

  • Knowledge of Care Options Test

    3 months

  • Knowledge of Care Options Test

    baseline

Secondary Outcomes (22)

  • Control Preferences Scale

    1 month

  • Medical Communication Competence Scale

    1 month

  • Measurement of Transitions Scale

    1 month

  • Chronic Disease Self-Efficacy Scale

    1 month

  • Hospital Anxiety and Depression Scale

    1 month

  • +17 more secondary outcomes

Study Arms (2)

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.

Behavioral: Self-Management Group

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.

Behavioral: Symptom Management Group

Interventions

Self-Management GroupBEHAVIORAL
Self-Management Group
Symptom Management GroupBEHAVIORAL
Symptom Management Group

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Yale School of Nursing

West Haven, Connecticut, 06516, United States

Location

Related Publications (1)

  • 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.

    PMID: 27107680DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dena Schulman-Green, PhD

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2014

First Posted

May 28, 2014

Study Start

June 1, 2014

Primary Completion

April 1, 2016

Study Completion

January 1, 2017

Last Updated

April 26, 2017

Record last verified: 2016-06

Locations

US(2)