Cancer MetastaticSFPRTNCT04049188
Access to Single-Fraction Palliative Radiation Therapy in Cancer Patients Enrolled in Hospice
A study testing Single-Fraction Palliative Radiation Therapy in people with Cancer Metastatic, run by Care Partners at 1 site in United States.
Trial summary
Feasibility study to report on the impact of ACCESS of single-fraction radiation therapy on cancer patients with bone metastases enrolled in hospice care. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cancer Metastatic
- What is being tested?
- Single-Fraction Palliative Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 31 Dec 2021
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Solid Tumor Malignancies and Multiple Myeloma with Bone Metastases and Associated Bone Pain Enrolled in Hospice
Who cannot join
- Decisionally-Impaired Subjects, Pregnant Women
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
CarePartners
Hillsboro, Oregon, 97006
Christa Nicholas, 503-648-9565
Andy Kyler, BSN, MBA
About this study
Official title: Impact of Access to Single-Fraction Palliative Radiation Therapy in Cancer Patients Enrolled in Hospice
Feasibility study to report on the impact of ACCESS of single-fraction radiation therapy on cancer patients with bone metastases enrolled in hospice care.
Read the detailed description
Hospice care for terminally ill patients with metastatic cancer improves quality of life, pain control, and potentially also survival when patients are enrolled early.1-3 However, hospice programs are often seen by patients and their caregivers as the last resort after exhaustion of all effective treatment options. The need to revoke active treatment (for all hospice patients with cancer outside of the VA system) discourages hospice enrollment.
This study aims to understand and analyze barriers to access specifically for short course palliative radiation therapy in cancer patients enrolled in hospice.
- Conditions
- Cancer Metastatic
- Being tested
- Single-Fraction Palliative Radiation Therapy
- Keywords
- Cancer Patients Hospice Care, Palliative Radiation Therapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Fraction Palliative Radiation TherapyRadiation
All subjects will be undergo single-fraction palliative radiation therapy who have cancer and associated bone metastases and symptomatic bone pain.
| Study group | Role | What they receive |
|---|---|---|
| Single-Fraction Palliative RT | Experimental | Single-Fraction Palliative Radiation Therapy Adminstration Receives: Radiation: Single-Fraction Palliative Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Opioid Use for Pain Management
Opioid Dosage (mg/day)
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Improved Quality of Life Measures
Questionnaires using Herth Hope Index, Timed Up and Go, and Edmonton Symptom Assessment Scale
Measured: During study completion
Improved Activities of Daily Living
Questionnaires using Hearth Hope Index, Timed Up and Go, and Edmonton Symptom Assessment Scale
Measured: During study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start1 Jan 2020
- Primary completion1 Jan 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer MetastaticStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Care Partners
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049188
- Sponsor's protocol ID
- 00019460
- Other IDs
- 20181015
- Acronym
- SFPRT
- Status last verified
- Jan 2020
- First submitted
- 5 Mar 2019
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Access to Single-Fraction Palliative Radiation Therapy in Cancer Patients Enrolled in Hospice
- ClinicalTrials.gov ID
- NCT04049188
- Acronym / sponsor ID
- SFPRT / 00019460
- Conditions
- Cancer Metastatic
- Keywords
- Cancer Patients Hospice Care, Palliative Radiation Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Care PartnersUniversity, hospital or other
- Collaborators
- OHSU Knight Cancer Institute, Oregon Health and Science University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 8 Aug 2019 (actual)
- 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.
Feasibility study to report on the impact of ACCESS of single-fraction radiation therapy on cancer patients with bone metastases enrolled in hospice care.
Detailed description
Hospice care for terminally ill patients with metastatic cancer improves quality of life, pain control, and potentially also survival when patients are enrolled early.1-3 However, hospice programs are often seen by patients and their caregivers as the last resort after exhaustion of all effective treatment options. The need to revoke active treatment (for all hospice patients with cancer outside of the VA system) discourages hospice enrollment.
This study aims to understand and analyze barriers to access specifically for short course palliative radiation therapy in cancer patients enrolled in hospice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Fraction Palliative RT | Experimental | Radiation: Single-Fraction Palliative Radiation TherapySingle-Fraction Palliative Radiation Therapy Adminstration |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Solid Tumor Malignancies and Multiple Myeloma with Bone Metastases and Associated Bone Pain Enrolled in Hospice
Key exclusion criteria (1 listed)
- Decisionally-Impaired Subjects, Pregnant Women
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 |
|---|---|---|
| Single-Fraction Palliative Radiation TherapyAll subjects will be undergo single-fraction palliative radiation therapy who have cancer and associated bone metastases and symptomatic bone pain. | Radiation | Single-Fraction Palliative RT |
Primary outcome
Change in Opioid Use for Pain Management
Time frame: Through study completion, an average of 1 year
Opioid Dosage (mg/day)
2 secondary outcomes
Improved Quality of Life Measures
Time frame: During study completion
Improved Activities of Daily Living
Time frame: During study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Fraction Palliative Radiation Therapy in people with Cancer Metastatic, run by Care Partners 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andy Kyler, BSN, MBA (5036192621, andy.kyler@carepartners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Opioid Use for Pain Management (time frame: Through study completion, an average of 1 year). 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 23 Jan 2020.