Ovarian CancerNCT02069769
Ensuring Communication in Hospice by Oncology Study (ECHO)
A study testing communication with oncology team in people with Ovarian Cancer and Cervical Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer, Cervical Cancer, Uterine Cancer
- What is being tested?
- communication with oncology team
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02215
About this study
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.
Read the 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.
- Conditions
- Ovarian Cancer, Cervical Cancer, Uterine Cancer, Head and Neck Cancer, Sarcoma, Melanoma
- Being tested
- communication with oncology team
- Keywords
- Hospice Care, Head and Neck cancer, Gynecological Oncology, Sarcoma, Melanoma
- Medical subject headings
- Ovarian Neoplasms, Uterine Cervical Neoplasms, Uterine Neoplasms, Head and Neck Neoplasms, Sarcoma, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
communication with oncology teamBehavioural
Oncology team will contact patients and families via telephone at specific intervals
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: communication with oncology team |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Years
Secondary outcomes (4)
Prospectively explore the satisfaction with the overall experience of family caregivers through questionnaires when receiving the ECHO intervention.
Measured: 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
Measured: 2 Years
Prospectively explore the levels of stress of family caregivers through questionnaires when receiving the ECHO intervention.
Measured: 2 years
Prospectively explore decision making regret of family caregivers through questionnaires when receiving the ECHO intervention.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Temel, MD, Massachusetts General Hospital
- Investigators
- Jennifer Temel, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069769
- Sponsor's protocol ID
- 13-540
- Status last verified
- Apr 2017
- First submitted
- 18 Feb 2014
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ensuring Communication in Hospice by Oncology Study (ECHO)
- ClinicalTrials.gov ID
- NCT02069769
- Acronym / sponsor ID
- 13-540
- Conditions
- Ovarian Cancer, Cervical Cancer, Uterine Cancer, Head and Neck Cancer, Sarcoma, Melanoma
- Keywords
- Hospice Care, Head and Neck cancer, Gynecological Oncology, Sarcoma, Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 24 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| communication with oncology team | Experimental | Behavioral: communication with oncology teamoncology team will be prompted to contact family caregiver and/or patient twice weekly while the patient is receiving hospice care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult Patient Criteria
- -->18years of age) with a diagnosis of an incurable malignancy of the head and neck, gynecological oncology, sarcoma, or melanoma
- Family Caregiver Eligibility Criteria:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| communication with oncology teamOncology team will contact patients and families via telephone at specific intervals | Behavioural | communication with oncology team |
Primary outcome
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
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.
4 secondary outcomes
Prospectively explore the satisfaction with the overall experience of family caregivers through questionnaires when receiving the ECHO intervention.
Time frame: 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
Time frame: 2 Years
Prospectively explore the levels of stress of family caregivers through questionnaires when receiving the ECHO intervention.
Time frame: 2 years
Prospectively explore decision making regret of family caregivers through questionnaires when receiving the ECHO intervention.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Temel, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing communication with oncology team in people with Ovarian Cancer and Cervical Cancer, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.