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Completed

NCT Number: NCT02148575

Integrating Palliative Care Into Self-Management of Breast Cancer

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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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale-New Haven Hospital, New Haven, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-management group

Behavioral

Symptom Management Group

Behavioral

Primary outcomes

  1. Knowledge of Care Options Test

    Time frame: 1 month

  2. Knowledge of Care Options Test

    Time frame: 3 months

  3. Knowledge of Care Options Test

    Time frame: baseline

Secondary outcomes

  1. Control Preferences Scale

    Time frame: 1 month

  2. Medical Communication Competence Scale

    Time frame: 1 month

  3. Measurement of Transitions Scale

    Time frame: 1 month

  4. Chronic Disease Self-Efficacy Scale

    Time frame: 1 month

  5. Hospital Anxiety and Depression Scale

    Time frame: 1 month

  6. Uncertainty in Illness Scale

    Time frame: 1 month

  7. Health Care Utilization Form

    Time frame: 3 months

  8. Goals of Care Conversations Form

    Time frame: 1 month

  9. Control Preferences Scale

    Time frame: 3 months

  10. Medical Communication Competence Scale

    Time frame: 3 months

  11. Measurement of Transitions Scale

    Time frame: 3 months

  12. Chronic Disease Self-Efficacy Scale

    Time frame: 3 months

  13. Hospital Anxiety and Depression Scale

    Time frame: 3 months

  14. Uncertainty in Illness Scale

    Time frame: 3 months

  15. Goals of Care Conversations Form

    Time frame: 3 months

  16. Control Preferences Scale

    Time frame: baseline

  17. Medical Communication Competence Scale

    Time frame: baseline

  18. Measurement of Transitions Scale

    Time frame: baseline

  19. Chronic Disease Self-Efficacy Scale

    Time frame: baseline

  20. Hospital Anxiety and Depression Scale

    Time frame: baseline

  21. Uncertainty in Illness Scale

    Time frame: baseline

  22. Goals of Care Conversations Form

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
May 28, 2014
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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