CancerNCT03712436
Examining Early Palliative Care in Newly Diagnosed Cancer Patients
A study testing Palliative care and Standard oncological care in people with Cancer, run by Yale University at 1 site in Ethiopia.
Trial summary
To understand the impact of initiation of palliative care in this low-resource setting, and whether palliative care is a cost-reducing intervention that will improve patient-reported outcomes and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Palliative care and Standard oncological care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Jun 2018to 15 Aug 2020
- 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
- Patients with any newly diagnosed cancer who are ambulatory and able to respond verbally to questions, are eligible for inclusion.
Who cannot join
- Patients who have not been diagnosed with cancer.
- Patients with diagnoses made more than 4 weeks ago, who are non-ambulatory, or are already receiving palliative care, are ineligible to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Early Palliative Care in Newly Diagnosed Cancer Patients at Black Lion Hospital, Addis Ababa, Ethiopia
To understand the impact of initiation of palliative care in this low-resource setting, and whether palliative care is a cost-reducing intervention that will improve patient-reported outcomes and quality of life.
Read the detailed description
The investigators overall goal is to understand the impact of initiation of early palliative care in an oncology population in a low-resource setting in order to provide guidance for future public health policies surrounding the provision of palliative care in Ethiopia. Hypothesis: The investigators hypothesize that initiation of palliative care in this low-resource setting is a cost-reducing intervention that will improve patient-reported outcomes and quality of life. Preliminary data: This research will focus on adult patients with oncologic diagnoses as preliminary research in this setting revealed that this patient population had the highest depression and anxiety scores, the lowest palliative outcome scores, and reported the highest costs of medical care.
- Conditions
- Cancer
- Being tested
- Palliative care, Standard oncological care
- Keywords
- Palliative Care, Supportive Care, Low Income Setting, LMIC, Africa
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative careCombination product
The Palliative Care Package is a protocol for Palliative Care delivery, derived from the African Palliative Care Association and adapted to the local environment in Addis Ababa.
Standard oncological careCombination product
Standard Oncological Care available in Addis Ababa, Ethiopia which includes chemotherapy, radiation oncology
| Study group | Role | What they receive |
|---|---|---|
| patients receiving palliative care | Experimental | Patients receiving standard oncologic care plus palliative care. Receives: Combination Product: Palliative care |
| patients receiving standard oncological care | Active comparator | Patients receiving standard oncologic care. Receives: Combination Product: Standard oncological care |
What is being measured
The primary outcome is the main question the study is designed to answer.
African Palliative Care Association Palliative Outcome Scale (APCA POS) score
APCA POS: APCA POS measures unpleasant symptoms (pain, worry, other symptoms) on a scale of 0-5 (best to worst). We will measure at baseline.
Measured: upon enrollment
African Palliative Care Association Palliative Outcome Scale (APCA POS) score
APCA POS: APCA POS measures unpleasant symptoms (pain, worry, other symptoms) on a scale of 0-5 (best to worst). We will compare baseline score to follow up score. An APCA POS score decrease of 3 from baseline will be signficant.
Measured: 12 weeks
Secondary outcomes (2)
Hospital Anxiety and Depression Score (HADS)
HADS score measures anxiety and depression on a scale of 0-3 (best to worst). We will measure at baseline.
Measured: upon enrollment
Hospital Anxiety and Depression Score (HADS)
HADS score measures anxiety and depression on a scale of 0-3 (best to worst). HADS score decrease from baseline, as measured at follow up.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start1 Jun 2018
- Primary completion15 Mar 2020
- Study completion15 Aug 2020
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 CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Model description
- A randomized controlled trial of standard oncologic care versus standard oncologic care plus palliative care in a newly diagnosed oncology population.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Addis Ababa University
- Responsible party
- Sponsor
- Investigators
- Eleanor Reid, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712436
- Sponsor's protocol ID
- 2000023057
- Status last verified
- Mar 2021
- First submitted
- 14 Sep 2018
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reid E, Abathun E, Diribi J, Mamo Y, Hall P, Fallon M, Wondemagegnhu T, Grant L. Rationale and study design: A randomized controlled trial of early palliative care in newly diagnosed cancer patients in Addis Ababa, Ethiopia. Contemp Clin Trials Commun. 2020 Apr 6;18:100564. doi: 10.1016/j.conctc.2020.100564. eCollection 2020 Jun.
PubMed 32309673
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Early Palliative Care in Newly Diagnosed Cancer Patients at Black Lion Hospital, Addis Ababa, Ethiopia
- ClinicalTrials.gov ID
- NCT03712436
- Acronym / sponsor ID
- 2000023057
- Conditions
- Cancer
- Keywords
- Palliative Care, Supportive Care, Low Income Setting, LMIC, Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Addis Ababa University
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 19 Oct 2018 (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.
To understand the impact of initiation of palliative care in this low-resource setting, and whether palliative care is a cost-reducing intervention that will improve patient-reported outcomes and quality of life.
Detailed description
The investigators overall goal is to understand the impact of initiation of early palliative care in an oncology population in a low-resource setting in order to provide guidance for future public health policies surrounding the provision of palliative care in Ethiopia. Hypothesis: The investigators hypothesize that initiation of palliative care in this low-resource setting is a cost-reducing intervention that will improve patient-reported outcomes and quality of life. Preliminary data: This research will focus on adult patients with oncologic diagnoses as preliminary research in this setting revealed that this patient population had the highest depression and anxiety scores, the lowest palliative outcome scores, and reported the highest costs of medical care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A randomized controlled trial of standard oncologic care versus standard oncologic care plus palliative care in a newly diagnosed oncology population.
| Arm | Type | Receives |
|---|---|---|
| patients receiving palliative care | Experimental | Combination Product: Palliative carePatients receiving standard oncologic care plus palliative care. |
| patients receiving standard oncological care | Active comparator | Combination Product: Standard oncological carePatients receiving standard oncologic care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with any newly diagnosed cancer who are ambulatory and able to respond verbally to questions, are eligible for inclusion.
Key exclusion criteria (2 listed)
- Patients who have not been diagnosed with cancer.
- Patients with diagnoses made more than 4 weeks ago, who are non-ambulatory, or are already receiving palliative care, are ineligible to participate in the study.
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 |
|---|---|---|
| Palliative careThe Palliative Care Package is a protocol for Palliative Care delivery, derived from the African Palliative Care Association and adapted to the local environment in Addis Ababa. | Combination product | patients receiving palliative care |
| Standard oncological careStandard Oncological Care available in Addis Ababa, Ethiopia which includes chemotherapy, radiation oncology | Combination product | patients receiving standard oncological care |
Primary outcome
African Palliative Care Association Palliative Outcome Scale (APCA POS) score
Time frame: upon enrollment
APCA POS: APCA POS measures unpleasant symptoms (pain, worry, other symptoms) on a scale of 0-5 (best to worst). We will measure at baseline.
African Palliative Care Association Palliative Outcome Scale (APCA POS) score
Time frame: 12 weeks
APCA POS: APCA POS measures unpleasant symptoms (pain, worry, other symptoms) on a scale of 0-5 (best to worst). We will compare baseline score to follow up score. An APCA POS score decrease of 3 from baseline will be signficant.
2 secondary outcomes
Hospital Anxiety and Depression Score (HADS)
Time frame: upon enrollment
Hospital Anxiety and Depression Score (HADS)
Time frame: 12 weeks
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 1 Apr 2021.
- Derived from this study: PubMed 32309673Reid E, Abathun E, Diribi J, Mamo Y, Hall P, Fallon M, Wondemagegnhu T, Grant L. Rationale and study design: A randomized controlled trial of early palliative care in newly diagnosed cancer patients in Addis Ababa, Ethiopia. Contemp Clin Trials Commun. 2020 Apr 6;18:100564. doi: 10.1016/j.conctc.2020.100564. eCollection 2020 Jun.
- HADSLink provided by the sponsor.
- APCA POSLink provided by the sponsor.
- 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.
Eleanor Reid, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative care and Standard oncological care in people with Cancer, run by Yale University at 1 site in Ethiopia.
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 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 1 Apr 2021. 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 Ethiopia. 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?
African Palliative Care Association Palliative Outcome Scale (APCA POS) score (time frame: upon enrollment). The study lists 2 primary outcomes in all. 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 NCT03712436, 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 1 Apr 2021.