Trial record 2 of 24 for:    Open Studies | "Hospice Care"

Ensuring Communication in Hospice by Oncology Study (ECHO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Jennifer Temel, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02069769
First received: February 18, 2014
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

The goal of this study is to determine if scheduled communication with the oncology team through phone calls is helpful to caregivers with the transition to hospice care.


Condition Intervention
Ovarian Cancer
Cervical Cancer
Uterine Cancer
Head and Neck Cancer
Sarcoma
Melanoma
Behavioral: communication with oncology team

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Ensuring Communication in Hospice by Oncology Study (ECHO)

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Evaluate the feasibility of implementing the Ensuring Communication in Hospice by Oncology Study (ECHO) intervention by patients' family caregivers and their oncology providers. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    ECHO will be considered feasible if greater than 70% of participants have > 50% of the scheduled phone contact with the oncology team during hospice care, which will be documented in the patient's medical record. Feasibility will also be demonstrated if greater than 70% of the family caregivers completing the questionnaires do so greater than 50% of the time they were scheduled. Finally, feasibility will also be demonstrated if caregivers are able to be contacted and decide upon participation within 5 days of patient hospice enrollment.


Secondary Outcome Measures:
  • Prospectively explore the satisfaction with the overall experience of family caregivers through questionnaires when receiving the ECHO intervention. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • Prospectively explore rates of health service utilization in the patients receiving the ECHO intervention in terms of (1) hospice disenrollment; (2) hospitalization; and (3) emergency department visits [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • Prospectively explore the levels of stress of family caregivers through questionnaires when receiving the ECHO intervention. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Prospectively explore decision making regret of family caregivers through questionnaires when receiving the ECHO intervention. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2014
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: communication with oncology team
oncology team will be prompted to contact family caregiver and/or patient twice weekly while the patient is receiving hospice care.
Behavioral: communication with oncology team

Detailed Description:

There are four parts of the study. First, the participant will receive phone calls twice a week from the oncology team to check in with how the transition to hospice is going. Second, the participant may choose to have an appointment with the Massachusetts General Hospital oncology team to discuss any questions or concerns regarding cancer care or the transition to hospice. Third, each week of hospice care, the participant will be asked to complete a set of questionnaires at a time that is convenient for them either by phone or by email. These questions will ask the participant about their recent thoughts and feelings about their experience with hospice and as a caregiver. The questions will take less than 15 minutes to answer. Fourth, after hospice care has ended, the participant will be called by the oncology team to again check in and about a month later, the participant will also be contacted by phone to complete a set of questionnaires, again asking about their thoughts and feelings about your experience with hospice and as a caregiver.

For all of the questionnaires, the participant may skip any questions that the participant prefers not to answer. The responses will remain confidential and will be available only to study staff members who are trained in confidentiality and research ethics.

Additionally, during the research study, the investigators will obtain information from the participant's loved one's Massachusetts General Hospital electronic medical record that is relevant to the participation in the study for up to 6 months. If he/she has visited another hospital during this time, the investigator will also ask the participant for their permission to obtain the medical records from this visit.

The participant will not receive any compensation for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult Patient Criteria

    -->18years of age) with a diagnosis of an incurable malignancy of the head and neck, gynecological oncology, sarcoma, or melanoma

    • Receiving oncology care at the MGH Cancer Center
    • Referral to home hospice services in previous five business days.
  • Family Caregiver Eligibility Criteria:

    • Designated adult family/informal caregiver for an eligible patient who will provide the primary home care for the patient receiving hospice services
    • Ability to read and respond to questions in English or with the assistance of a translator
    • Access to telephone and/or computer to communicate with the oncology team and complete questionnaires
    • Willingness to complete weekly questionnaires via telephone or email.

Exclusion Criteria:

  • Patient Exclusion Criteria:

    -- Referral to hospice services away from home (eg in nursing home or in an inpatient or residential setting)

  • Family Caregiver Exclusion Criteria --Person is not the primary caregiver for the patient
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02069769

Contacts
Contact: Jennifer Temel, MD 617-724-4000 jtemel@partners.org
Contact: Jessica Bauman, MD 617-724-4000 ext 33257 jrbauman@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jennifer Temel, MD    617-724-4000    jtemel@partners.org   
Contact: Jessica Bauman, MD    617-724-4000 ext 33257    jrbauman@partners.org   
Principal Investigator: Jennifer Temel, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Jennifer Temel, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Jennifer Temel, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02069769     History of Changes
Other Study ID Numbers: 13-540
Study First Received: February 18, 2014
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Hospice Care
Head and Neck cancer
Gynecological Oncology
Sarcoma
Melanoma

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Head and Neck Neoplasms
Melanoma
Ovarian Neoplasms
Uterine Neoplasms
Sarcoma
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on August 21, 2014