DeathSCPNCT02112461
Hospice and End-of-life Symptom Monitoring & Support Using an Automated System Designed for Family Caregivers
A study testing SCP-Hospice Alert in people with Death and Cancer, run by University of Utah at 1 site in United States.
Trial summary
Improving end-of-life care and the suffering caused by poorly controlled symptoms is an important public health concern. The development of an automated telephone symptom monitoring and support system that assists caregivers in providing end-of-life care and communicating information to the patient's hospice nurse has… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- SCP-Hospice Alert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- patient not being cared for by a partnering hospice
- patient without a histological diagnosis of cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah College of Nursing
Salt Lake City, Utah, 84112
About this study
Official title: Enhancing End-of-Life and Bereavement Outcomes Among Cancer Caregivers: Symptom Care by Phone for Hospice Caregiver Support and Cancer Symptom Relief
Improving end-of-life care and the suffering caused by poorly controlled symptoms is an important public health concern. The development of an automated telephone symptom monitoring and support system that assists caregivers in providing end-of-life care and communicating information to the patient's hospice nurse has the potential to enhance the management of common end of life symptoms, thus reducing the suffering of patients at end of life as well as the suffering of their family caregivers. This study has developed such a system and is testing the effectiveness of this system.
Read the detailed description
Individuals dying from cancer often live out their lives at home with a host of poorly controlled symptoms. Ineffective symptom management results, in part, from inadequate monitoring of patients once they leave the treatment-focused arena of the clinical setting. The changing pattern of symptoms is challenging as care strategies and recommendations from previous encounters with healthcare providers become quickly outdated. The burden of end-of-life care largely falls to family caregivers, usually a spouse or partner, who feel enormous pressure to provide physical and supportive care but often lacks the knowledge and skill resulting in significant caregiver burden and distress that may extend into bereavement.
This prospective, clinical trial proposes to develop and test a telecommunication system, Symptom Care by Phone- Hospice that has been designed to bridge the divide between home and palliative care support for patients at the end of life and their family caregiver. SCP-Hospice has three elements: 1) daily monitoring of symptoms common at end of life, 2) automated alerting of the hospice nurse case manager about symptoms that have exceeded a pre-set threshold for symptom severity or caregiver distress about symptoms, and 3) automated, just in time, tailored care management strategies for the caregiver to implement to address the patient's symptoms. Caregivers call the SCP-Hospice system daily to report patient symptoms and then are immediately provided automated, tailored care suggestions paired to the specific symptom profile.
The specific aims of the study are to test whether the SCP-Hospice intervention reduces severity and distress from 12 different symptoms and whether it decreases caregiver burden, anxiety, depressed mood and distress about the patient's symptoms and improves caregiver sleep when compared with usual care. The mechanisms that explain how SCP-Hospice affect these outcomes also will be explored. Other aims will compare patient care strategies utilized by caregivers and evaluate caregiver and Hospice nurse satisfaction with the SCP system.
- Being tested
- SCP-Hospice Alert
- Keywords
- end of life care
- Medical subject headings
- Death, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCP-Hospice AlertBehavioural
The intervention in Project 1 SCP utilizes a multi-faceted system. The SCP-Hospice symptom management model will include several features: 1) a computer-based telecommunication system to monitor symptoms as perceived and reported by the family caregiver; 2) tailored care management messages that SCP provides directly to the caregivers to promote care management based on the individualized patient symptom profile and caregiver distress; and 3) an automated alerting function that notifies the hospice nurse of unrelieved symptoms that have exceeded a pre-set threshold.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | SCP-Hospice Alert Receives: Behavioral: SCP-Hospice Alert |
| Usual Care | No intervention | Caregiver calls into monitoring system to report the patient's end of life symptoms but does not receive feedback about the symptoms and the hospice nurse does not receive the information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Caregiver's Assessment of Dying Patient's Symptom Severity Level at End-of-Life
Caregiver's report their assessment of the severity of patient's symptoms daily.
Measured: Changes in patient's end-of-life symptom levels are reported daily by the family caregiver from baseline (date of consent) until the patient's death or 6 months whichever occurs last.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startMay 2010
- Primary completionMar 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeathStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kathleen Mooney, University of Utah
- Investigators
- Kathleen H Mooney, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112461
- Sponsor's protocol ID
- 33122-SCP
- Other IDs
- 1P01CA138317
- Acronym
- SCP
- Status last verified
- Feb 2017
- First submitted
- 28 Feb 2014
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mooney K, Whisenant MS, Wilson CM, Coombs LA, Lloyd J, Alekhina N, Sloss EA, Steinbach M, Moraitis AM, Berry P, Iacob E, Donaldson G. Technology-Assisted mHealth Caregiver Support to Manage Cancer Patient Symptoms: A Randomized Controlled Trial. J Pain Symptom Manage. 2023 Jul;66(1):33-43. doi: 10.1016/j.jpainsymman.2023.02.320. Epub 2023 Mar 7.
PubMed 36889453
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing End-of-Life and Bereavement Outcomes Among Cancer Caregivers: Symptom Care by Phone for Hospice Caregiver Support and Cancer Symptom Relief
- ClinicalTrials.gov ID
- NCT02112461
- Acronym / sponsor ID
- SCP / 33122-SCP
- Keywords
- end of life care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2010
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 14 Apr 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.
Improving end-of-life care and the suffering caused by poorly controlled symptoms is an important public health concern. The development of an automated telephone symptom monitoring and support system that assists caregivers in providing end-of-life care and communicating information to the patient's hospice nurse has the potential to enhance the management of common end of life symptoms, thus reducing the suffering of patients at end of life as well as the suffering of their family caregivers. This study has developed such a system and is testing the effectiveness of this system.
Detailed description
Individuals dying from cancer often live out their lives at home with a host of poorly controlled symptoms. Ineffective symptom management results, in part, from inadequate monitoring of patients once they leave the treatment-focused arena of the clinical setting. The changing pattern of symptoms is challenging as care strategies and recommendations from previous encounters with healthcare providers become quickly outdated. The burden of end-of-life care largely falls to family caregivers, usually a spouse or partner, who feel enormous pressure to provide physical and supportive care but often lacks the knowledge and skill resulting in significant caregiver burden and distress that may extend into bereavement.
This prospective, clinical trial proposes to develop and test a telecommunication system, Symptom Care by Phone- Hospice that has been designed to bridge the divide between home and palliative care support for patients at the end of life and their family caregiver. SCP-Hospice has three elements: 1) daily monitoring of symptoms common at end of life, 2) automated alerting of the hospice nurse case manager about symptoms that have exceeded a pre-set threshold for symptom severity or caregiver distress about symptoms, and 3) automated, just in time, tailored care management strategies for the caregiver to implement to address the patient's symptoms. Caregivers call the SCP-Hospice system daily to report patient symptoms and then are immediately provided automated, tailored care suggestions paired to the specific symptom profile.
The specific aims of the study are to test whether the SCP-Hospice intervention reduces severity and distress from 12 different symptoms and whether it decreases caregiver burden, anxiety, depressed mood and distress about the patient's symptoms and improves caregiver sleep when compared with usual care. The mechanisms that explain how SCP-Hospice affect these outcomes also will be explored. Other aims will compare patient care strategies utilized by caregivers and evaluate caregiver and Hospice nurse satisfaction with the SCP system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: SCP-Hospice AlertSCP-Hospice Alert |
| Usual Care | No intervention | –Caregiver calls into monitoring system to report the patient's end of life symptoms but does not receive feedback about the symptoms and the hospice nurse does not receive the information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- patient not being cared for by a partnering hospice
- patient without a histological diagnosis of cancer
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 |
|---|---|---|
| SCP-Hospice AlertThe intervention in Project 1 SCP utilizes a multi-faceted system. The SCP-Hospice symptom management model will include several features: 1) a computer-based telecommunication system to monitor symptoms as perceived and reported by the family caregiver; 2) tailored care management messages that SCP provides directly to the caregivers to promote care management based on the individualized patient symptom profile and caregiver distress; and 3) an automated alerting function that notifies the hospice nurse of unrelieved symptoms that have exceeded a pre-set threshold. | Behavioural | Intervention Group |
Primary outcome
Family Caregiver's Assessment of Dying Patient's Symptom Severity Level at End-of-Life
Time frame: Changes in patient's end-of-life symptom levels are reported daily by the family caregiver from baseline (date of consent) until the patient's death or 6 months whichever occurs last.
Caregiver's report their assessment of the severity of patient's symptoms daily.
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 17 May 2017.
- Derived from this study: PubMed 36889453Mooney K, Whisenant MS, Wilson CM, Coombs LA, Lloyd J, Alekhina N, Sloss EA, Steinbach M, Moraitis AM, Berry P, Iacob E, Donaldson G. Technology-Assisted mHealth Caregiver Support to Manage Cancer Patient Symptoms: A Randomized Controlled Trial. J Pain Symptom Manage. 2023 Jul;66(1):33-43. doi: 10.1016/j.jpainsymman.2023.02.320. Epub 2023 Mar 7.
- Individual participant dataSharing planned: No
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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.
Kathleen H Mooney, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCP-Hospice Alert in people with Death and Cancer, run by University of Utah 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 0 inclusion and 2 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 17 May 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?
Family Caregiver's Assessment of Dying Patient's Symptom Severity Level at End-of-Life (time frame: Changes in patient's end-of-life symptom levels are reported daily by the family caregiver from baseline (date of consent) until the patient's death or 6 months whichever occurs last.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02112461, which also lists 1 linked publication.
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 17 May 2017.