NCT02069769

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable ovarian-cancer

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

2.3 years

First QC Date

February 18, 2014

Last Update Submit

April 15, 2017

Conditions

Ovarian CancerCervical CancerUterine CancerHead and Neck CancerSarcomaMelanoma

Keywords

Hospice CareHead and Neck cancerGynecological OncologySarcomaMelanoma

Outcome Measures

Primary Outcomes (1)

  • Evaluate the feasibility of implementing the Ensuring Communication in Hospice by Oncology Study (ECHO) intervention by patients' family caregivers and their oncology providers.

    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.

    2 Years

Secondary Outcomes (4)

  • Prospectively explore the satisfaction with the overall experience of family caregivers through questionnaires when receiving the ECHO intervention.

    2 Years

  • 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

    2 Years

  • Prospectively explore the levels of stress of family caregivers through questionnaires when receiving the ECHO intervention.

    2 years

  • Prospectively explore decision making regret of family caregivers through questionnaires when receiving the ECHO intervention.

    2 years

Study Arms (1)

communication with oncology team

EXPERIMENTAL

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

Interventions

communication with oncology teamBEHAVIORAL

Oncology team will contact patients and families via telephone at specific intervals

communication with oncology team

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsUterine Cervical NeoplasmsUterine NeoplasmsHead and Neck NeoplasmsSarcomaMelanoma

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine Cervical DiseasesUterine DiseasesNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jennifer Temel, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 18, 2014

First Posted

February 24, 2014

Study Start

January 1, 2014

Primary Completion

May 1, 2016

Study Completion

January 1, 2017

Last Updated

April 18, 2017

Record last verified: 2017-04

Locations

US(1)