Integrating palliative care into self-management of breast cancer: Protocol for a pilot randomized controlled trial.
Despite evidence that palliative care increases quality and length of life, many patients and families remain uninformed about its nature and benefits. The purpose of this study is to test a psycho-educational intervention, Managing Cancer Care: A Personal Guide (MCC), intended to improve breast cancer patients' knowledge of palliative care and to facilitate its timely integration into cancer self-management.



Aims are to: 1) evaluate the effects of MCC on patients' knowledge of palliative care; 2) examine preliminary effects of MCC on patients' behaviors (role in self-management, engagement in goals of care conversations, medical communication, management of transitions, health care utilization), and feelings (self-efficacy, anxiety, depression, uncertainty); and 3) evaluate protocol feasibility and acceptability. An exploratory aim is to investigate how demographic and clinical factors may moderate intervention effects, with emphasis on differences in use and outcomes among minority participants. We plan to enroll 60 patients and their family caregivers with 50% minority participation. The intervention group receives MCC; the attention-control group receives a Symptom Management Toolkit. We collect data at baseline, one, and three months.



This study will inform a large scale trial of MCC. It is challenging for patients with breast cancer, their family caregivers, and providers to make choices that include palliation alone or in combination with potentially curative treatment. MCC may help address this challenge by giving patients the information, skills, and confidence to better self-manage breast cancer. Results may help to establish palliative care as a mainstay of self-management interventions targeting serious illness.



ClinicalTrials.gov Identifier NCT02148575 (date registered: 5.21.14; date first patient enrolled: 7.15.14).
Yale School of Nursing, PO Box 27399, West Haven, CT 06516, United States. Electronic address: dena.schulman-green@yale.edu.
Dena
D
Schulman-Green
Yale School of Nursing, PO Box 27399, West Haven, CT 06516, United States. Electronic address: sarah.linsky@yale.edu.
Sarah
S
Linsky
Yale School of Nursing, PO Box 27399, West Haven, CT 06516, United States. Electronic address: sangchoon.jeon@yale.edu.
Sangchoon
S
Jeon
Smilow Cancer Hospital, PO Box 208025, LMP 1072, New Haven, CT 06520, United States. Electronic address: jennifer.kapo@yale.edu.
Jennifer
J
Kapo
Smilow Cancer Hospital, PO Box 208025, LMP 1072, New Haven, CT 06520, United States. Electronic address: leslie.blatt@ynhh.org.
Leslie
L
Blatt
Yale University School of Medicine, The Breast Center - Smilow Cancer Hospital at Yale-New Haven, 20 York Street, New Haven, CT 06510, United States. Electronic address: anees.chagpar@yale.edu.
Anees
A
Chagpar
D001007:Anxiety / Q000523:psychology; D001943:Breast Neoplasms / Q000523:psychology / Q000628:therapy*; D003863:Depression / Q000523:psychology; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D010166:Palliative Care; D010353:Patient Education as Topic / Q000379:methods*; D010865:Pilot Projects; D020377:Self Efficacy; D000073278:Self-Management; D016037:Single-Blind Method
Breast cancer; Palliative care; Self-management