Non-Small Cell Lung CancerAIRPALNCT07039994
Early Palliative Care in Patients With Advanced Lung Cancer Using an e-Health Ecosystem
A study testing Standard intervention and E-health intervention in people with Non-Small Cell Lung Cancer, run by Jesús González at 2 sites in Spain.
Trial summary
Palliative care has long been associated primarily with end-of-life support. However, its scope is much broader. As highlighted in the Hastings Center Report, the purposes of medicine include not only curing disease but also preventing illness, relieving suffering, caring for patients, avoiding preventable deaths, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Standard intervention and E-health intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSpain
- Study dates
- 24 Dec 2024to 24 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 diagnosed with advanced NSCLC (stage III or IV) with criteria for early palliative intervention*, seen in the initial palliative care consultation.
- Patients or primary caregivers with internet proficiency and access to computer and telephone equipment.
- Patients with ECOG performance status 0-3
- For the purposes of this study, patients with the following conditions will be considered candidates for early palliative care: a tumor diagnosis ≤3 months prior to diagnosis and one or more of the following criteria: average pain poorly controlled with opioids (VAS score ≥4); dyspnea on minor exertion; patients <60 years of age; emotional distress (HADS ≥10); family fragility; functional limitation (Barthel <60); history or use of drugs; and the presence of ethical or existential dilemmas (Llorens et al., 2017; Tuca et al., 2019).
Who cannot join
- Patients who do not meet criteria for early palliative intervention.
- Patients with severe cognitive impairment or psychiatric impairment that prevents proper evaluation.
- Patients who do not speak or understand Catalan or Spanish adequately.
- Patients who, at the first visit, are in a serious clinical condition that prevents proper evaluation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Not yet recruiting
Catalan Institute of Oncology
Badalona, Barcelona, 08916
Agnès Calsina Berna, MD, PhD, 934978800 ext. +34, acalsina@iconcologia.net
- Recruiting
Catalan Institute of Oncology
L'Hospitalet de Llobregat, Barcelona, 08908
Jesús González Barboteo, MD, PhD, 932607733 ext. +34, jgonzalez@iconcologia.net
About this study
Official title: Early Palliative Care in Patients With Advanced Lung Cancer Using an e-Health Ecosystem: a Randomized, Controlled, and Blinded Clinical Trial
Palliative care has long been associated primarily with end-of-life support. However, its scope is much broader. As highlighted in the Hastings Center Report, the purposes of medicine include not only curing disease but also preventing illness, relieving suffering, caring for patients, avoiding preventable deaths, and ensuring a peaceful death when unavoidable. Palliative care plays a vital role in achieving all of these goals. In addition to pain and symptom management, it addresses the prevention of complicated grief, the emergence of severe symptoms (e.g., constipation, delirium), the inappropriate use of end-of-life treatments, and offers specialized care for incurable diseases.
This model of care follows a multidimensional and multidisciplinary approach, focusing on the person beyond the illness and addressing emotional, social, spiritual, and practical needs. Recent studies have shown that early integration of palliative care within routine oncology improves symptom control, emotional well-being, and coping with the illness. Furthermore, it enhances quality of life for both patients and their families, reduces healthcare resource usage, and does not increase overall health expenditure.
Read more
Such early integration also facilitates discussions about end-of-life issues, promotes advance care planning, and supports improved home-based palliative care. Additionally, it has been associated with fewer aggressive treatments and a positive impact on patient survival.
Systematic symptom assessment leads to earlier and more effective management. In this context, information and communication technologies (ICTs) have shown promise in enabling remote monitoring and care delivery. These tools can enhance quality of life, improve treatment adherence, reduce emergency visits, and positively influence survival. However, existing studies have limitations, such as small sample sizes and lack of evaluator blinding.
The COVID-19 pandemic emphasized the need for physical distancing and accelerated the development of remote healthcare systems. Some specialized cancer centers, like the Institut Català d'Oncologia, have implemented functional multidisciplinary units for each cancer type. These units consist of various specialists (medical oncologists, radiation oncologists, surgeons, radiologists, pathologists, advanced practice nurses, palliative care professionals, etc.) who collaboratively decide the best course of treatment. A key role within these units is the reference nurse, assigned to each patient, who acts as a main point of contact, available for in-person or phone consultations.
One major improvement in recent years has been the integration of palliative care clinics within oncology departments. Best practices now emphasize early palliative intervention based on patient complexity and needs. While no universal definition exists, most studies define "early palliative care" as involvement by a palliative team within the first three months following a diagnosis of advanced cancer. This approach is supported by multiple scientific societies. Nevertheless, challenges such as limited resources, accessibility barriers, and increasing in-person demand near the end of life remain significant obstacles.
Among advanced cancers, lung cancer stands out due to its high prevalence and poor prognosis. It is characterized by frequent and unpredictable symptoms, requiring flexible and responsive follow-up. Adapting care to patients' changing needs could improve quality of life, optimize resources, and reduce the frequency of in-person visits.
This study proposes the integration of early palliative care with an e-Health ecosystem, reflecting the global push to bring care into the homes of vulnerable patients using modern technology. Evidence for the impact of ICTs in palliative care remains limited, and existing studies are generally of low quality. To date, only one registered trial (NCT03375489) has explored e-Health in early palliative care. Unlike that study, this research offers a scalable model tailored to patient complexity, alongside a comprehensive cost-utility evaluation (e.g., fewer in-person visits, emergency care use, and patient transfers to care centers).
This is the first international clinical trial of its kind in palliative care. It is a multicenter, randomized, controlled trial with blinded third-party evaluation. The hypothesis is that an e-Health ecosystem with ICT tools will improve access, early detection, monitoring, and remote palliative intervention for lung cancer patients.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Standard intervention, E-health intervention
- Keywords
- Palliative Care, e-Health, Telemedicine, Early Treatment
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard interventionOther
Routine intervention in the service:
- Good control: In-person visit every 4 weeks.
- Poor control: Nurse calls at 1 week to assess and decide on treatment changes, visits, or referral. In-person visit by need or after 1 month.
E-health interventionOther
Combined system using ICT and in-person care. It includes spontaneous use (symptom tracking, messages, reminders via app) and scheduled use:
- Good symptom control: Basic Telematic Evaluation (BTE) at 1 month. If stable, videoconference at 2 months, BTE at 3 months, and in-person visit at 4 months.
- Poor symptom control: BTE at 1 week. If warning signs appear, a nurse evaluates by phone and may adjust treatment, schedule a visit (in-person or video), or refer to emergency care. In-person visit by need or after 1 month.
| Study group | Role | What they receive |
|---|---|---|
| E-health follow-up | Experimental | Not described Receives: Other: E-health intervention |
| Standard follow-up | Active comparator | Not described Receives: Other: Standard intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACT-L
Functional Assessment of Cancer Therapy-Lung Minimum and maximum values: 0-136 worst to best quality of life
Measured: Baseline, 3, 6, 9 and 12 months
Secondary outcomes (19)
ESAS-r
Edmonton Symptom Assessment System Minimum and maximum values: 0-1, meaning no symptom to 11 symptoms scored 0-10 /110
Measured: Baseline, 3, 6, 9 and 12 months
HADS
Hospital Anxiety and Depression Scale Ranges from 0-42. Higher scores indicate greater anxiety and/or depression symptoms.
Measured: Baseline, 3, 6, 9 and 12 months
EQ-5D-3L
European Quality of Life Scale Scale Ranges from 5-15, with 5 being best Quality of Life
Measured: Baseline, 3, 6, 9 and 12 months
ARMS
Adherence to Refills and Medications Values ranges from 12 to 48, being 12 maximum adherence to refills
Measured: Baseline, 3, 6 ,9 and 12 months
CTCAE
Common Toxicology Criteria for Adverse Events Grade 1. Mild: Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2. Moderate: Minimal, local, or noninvasive intervention indicated; limitation of age-appropriate instrumental Activities of Daily Living (ADLs).
Grade 3. Severe or medically significant but not immediately life-threatening: Hospitalization or prolongation of hospitalization indicated; disabling; limits self-care ADLs.
Grade 4. Life-threatening consequences: Urgent intervention indicated. Grade 5. Death related to adverse event (AE).
Measured: Baseline, 3, 6, 9 and 12 months
Opioid dose
Daily oral morphine equivalent dose, in miligrams/day
Measured: Baseline, 3, 6, 9 and 12 months
Hospitalization rate
Measured: 3, 6, 9 and 12 months
PSCRCM
Patient Satisfaction with Cancer-Related Care Measure Scale between 18 to 90, being 18 maximum satisfaction
Measured: Baseline, 3, 6, 9 and 12 months
Charlson Index
Comorbidity Scale ranging between 0 to 32, being 0 no comorbidities and 32 all comorbidities of the test
Measured: Baseline, 3, 6, 9 and 12 months
PPS
Palliative Performance Scale Percentage (100-10), being 100 normal functionality and 10 patient completely bedridden, no possibility of work, complete depence for selfcare, only able to ingest solids and sleepy or in a coma
Measured: Baseline, 3, 6, 9 and 12 months
ECOG
Eastern Cooperative Oncology Group (functionality) Grade 0: The patient is completely asymptomatic and is able to perform normal work and daily life activities.
Grade 1: The patient has symptoms that prevent them from doing strenuous work but is able to carry out normal daily activities and light work. The patient only stays in bed during nighttime sleep hours.
Grade 2: The patient is unable to perform any work and has symptoms that force them to stay in bed for several hours during the day, in addition to nighttime, but not exceeding 50% of the day. The individual manages most of their personal needs independently.
Grade 3: The patient needs to be bedridden for more than half of the day due to symptoms. They require assistance with most activities of daily living, such as dressing.
Grade 4: The patient needs to be bedridden 100% of the day and requires help with all activities of daily living, such as personal hygiene, moving in bed, and even feeding.
Grade 5: Patient deceased.
Measured: Baseline, 3, 6, 9 and 12 months
Pfeiffer questionaire
Cognitive State Scale between -1 to 9, being -1 intact and 9 severe impairment
Measured: Baseline, 3, 6, 9 and 12 months
BPI
Brief Pain Inventory Scale between 0 to 10 to determine maximum, minimum and mean pain in the last 24 hours, being 0 no pain and 10 maximum pain Percentage to determine interference of pain with activities, or to determine pain improvement after medication
Measured: Baseline, 3, 6, 9 and 12 months
Age
Number
Measured: Baseline registry
Sex
Male or female
Measured: Baseline
Type of cancer
Adenocarcinoma, scamous carcinoma or indiferentiated
Measured: Baseline
Stage
IA, IB, IIA, IIB, IIIA, IIB, IIIC, IVA or IVB
Measured: Baseline
Aim of the onco-specific treatment
Curative, palliative, non-decided or non onco-specific treatment
Measured: Baseline
Type of onco-specific treatment
Chemotherapy, radiotherapy, surgery, Inmunotherapy, Targeted Therapy or non-onco-specific treatment
Measured: Baseline, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start24 Dec 2024
- Primary completion24 Mar 2028 (estimated)
- Study completion24 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group - e-Health follow-up, a combined system using ICT and in-person care. It includes spontaneous use (symptom tracking, messages, reminders via app) and scheduled use: * Good symptom control: Basic Telematic Evaluation (BTE) at 1 month. If stable, videoconference at 2 months, BTE at 3 months, and in-person visit at 4 months. * Poor symptom control: BTE at 1 week. If warning signs appear, a nurse evaluates by phone and may adjust treatment, schedule a visit (in-person or video), or refer to emergency care. In-person visit by need or after 1 month. Control group - Standard follow-up: * Good control: In-person visit every 4 weeks. * Poor control: Nurse calls at 1 week to assess and decide on treatment changes, visits, or referral. In-person visit by need or after 1 month.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jesús González
- Sponsor type
- Other government
- Collaborators
- Institut Català d'Oncologia, Institut d'Investigació Biomèdica de Bellvitge
- Responsible party
- Sponsor-investigator, Jesús González, Instituto de Salud Carlos III
- Investigators
- Jesús González Barboteo, MD, PhD, Principal investigator, Catalan Institute of Oncology (ICO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039994
- Sponsor's protocol ID
- AIRPAL-010521
- Other IDs
- PR274/21
- Acronym
- AIRPAL
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 26 Jun 2025
- 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 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Palliative Care in Patients With Advanced Lung Cancer Using an e-Health Ecosystem: a Randomized, Controlled, and Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT07039994
- Acronym / sponsor ID
- AIRPAL / AIRPAL-010521
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Palliative Care, e-Health, Telemedicine, Early Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jesús GonzálezOther government
- Collaborators
- Institut Català d'Oncologia, Institut d'Investigació Biomèdica de Bellvitge
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 24 Mar 2028 (estimated)
- Study completion
- 24 Jul 2028 (estimated)
- First posted
- 26 Jun 2025 (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.
Palliative care has long been associated primarily with end-of-life support. However, its scope is much broader. As highlighted in the Hastings Center Report, the purposes of medicine include not only curing disease but also preventing illness, relieving suffering, caring for patients, avoiding preventable deaths, and ensuring a peaceful death when unavoidable. Palliative care plays a vital role in achieving all of these goals. In addition to pain and symptom management, it addresses the prevention of complicated grief, the emergence of severe symptoms (e.g., constipation, delirium), the inappropriate use of end-of-life treatments, and offers specialized care for incurable diseases.
This model of care follows a multidimensional and multidisciplinary approach, focusing on the person beyond the illness and addressing emotional, social, spiritual, and practical needs. Recent studies have shown that early integration of palliative care within routine oncology improves symptom control, emotional well-being, and coping with the illness. Furthermore, it enhances quality of life for both patients and their families, reduces healthcare resource usage, and does not increase overall health expenditure.
Such early integration also facilitates discussions about end-of-life issues, promotes advance care planning, and supports improved home-based palliative care. Additionally, it has been associated with fewer aggressive treatments and a positive impact on patient survival.
Systematic symptom assessment leads to earlier and more effective management. In this context, information and communication technologies (ICTs) have shown promise in enabling remote monitoring and care delivery. These tools can enhance quality of life, improve treatment adherence, reduce emergency visits, and positively influence survival. However, existing studies have limitations, such as small sample sizes and lack of evaluator blinding.
The COVID-19 pandemic emphasized the need for physical distancing and accelerated the development of remote healthcare systems. Some specialized cancer centers, like the Institut Català d'Oncologia, have implemented functional multidisciplinary units for each cancer type. These units consist of various specialists (medical oncologists, radiation oncologists, surgeons, radiologists, pathologists, advanced practice nurses, palliative care professionals, etc.) who collaboratively decide the best course of treatment. A key role within these units is the reference nurse, assigned to each patient, who acts as a main point of contact, available for in-person or phone consultations.
One major improvement in recent years has been the integration of palliative care clinics within oncology departments. Best practices now emphasize early palliative intervention based on patient complexity and needs. While no universal definition exists, most studies define "early palliative care" as involvement by a palliative team within the first three months following a diagnosis of advanced cancer. This approach is supported by multiple scientific societies. Nevertheless, challenges such as limited resources, accessibility barriers, and increasing in-person demand near the end of life remain significant obstacles.
Among advanced cancers, lung cancer stands out due to its high prevalence and poor prognosis. It is characterized by frequent and unpredictable symptoms, requiring flexible and responsive follow-up. Adapting care to patients' changing needs could improve quality of life, optimize resources, and reduce the frequency of in-person visits.
This study proposes the integration of early palliative care with an e-Health ecosystem, reflecting the global push to bring care into the homes of vulnerable patients using modern technology. Evidence for the impact of ICTs in palliative care remains limited, and existing studies are generally of low quality. To date, only one registered trial (NCT03375489) has explored e-Health in early palliative care. Unlike that study, this research offers a scalable model tailored to patient complexity, alongside a comprehensive cost-utility evaluation (e.g., fewer in-person visits, emergency care use, and patient transfers to care centers).
This is the first international clinical trial of its kind in palliative care. It is a multicenter, randomized, controlled trial with blinded third-party evaluation. The hypothesis is that an e-Health ecosystem with ICT tools will improve access, early detection, monitoring, and remote palliative intervention for lung cancer patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental group - e-Health follow-up, a combined system using ICT and in-person care. It includes spontaneous use (symptom tracking, messages, reminders via app) and scheduled use: * Good symptom control: Basic Telematic Evaluation (BTE) at 1 month. If stable, videoconference at 2 months, BTE at 3 months, and in-person visit at 4 months. * Poor symptom control: BTE at 1 week. If warning signs appear, a nurse evaluates by phone and may adjust treatment, schedule a visit (in-person or video), or refer to emergency care. In-person visit by need or after 1 month. Control group - Standard follow-up: * Good control: In-person visit every 4 weeks. * Poor control: Nurse calls at 1 week to assess and decide on treatment changes, visits, or referral. In-person visit by need or after 1 month.
| Arm | Type | Receives |
|---|---|---|
| E-health follow-up | Experimental | Other: E-health intervention |
| Standard follow-up | Active comparator | Other: Standard intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with advanced NSCLC (stage III or IV) with criteria for early palliative intervention*, seen in the initial palliative care consultation.
- Patients or primary caregivers with internet proficiency and access to computer and telephone equipment.
- Patients with ECOG performance status 0-3
Key exclusion criteria (4 listed)
- Patients who do not meet criteria for early palliative intervention.
- Patients with severe cognitive impairment or psychiatric impairment that prevents proper evaluation.
- Patients who do not speak or understand Catalan or Spanish adequately.
- Patients who, at the first visit, are in a serious clinical condition that prevents proper evaluation.
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 |
|---|---|---|
| Standard interventionRoutine intervention in the service: * Good control: In-person visit every 4 weeks. * Poor control: Nurse calls at 1 week to assess and decide on treatment changes, visits, or referral. In-person visit by need or after 1 month. | Other | Standard follow-up |
| E-health interventionCombined system using ICT and in-person care. It includes spontaneous use (symptom tracking, messages, reminders via app) and scheduled use: * Good symptom control: Basic Telematic Evaluation (BTE) at 1 month. If stable, videoconference at 2 months, BTE at 3 months, and in-person visit at 4 months. * Poor symptom control: BTE at 1 week. If warning signs appear, a nurse evaluates by phone and may adjust treatment, schedule a visit (in-person or video), or refer to emergency care. In-person visit by need or after 1 month. | Other | E-health follow-up |
Primary outcome
FACT-L
Time frame: Baseline, 3, 6, 9 and 12 months
Functional Assessment of Cancer Therapy-Lung Minimum and maximum values: 0-136 worst to best quality of life
19 secondary outcomes
ESAS-r
Time frame: Baseline, 3, 6, 9 and 12 months
HADS
Time frame: Baseline, 3, 6, 9 and 12 months
EQ-5D-3L
Time frame: Baseline, 3, 6, 9 and 12 months
ARMS
Time frame: Baseline, 3, 6 ,9 and 12 months
CTCAE
Time frame: Baseline, 3, 6, 9 and 12 months
Opioid dose
Time frame: Baseline, 3, 6, 9 and 12 months
Hospitalization rate
Time frame: 3, 6, 9 and 12 months
PSCRCM
Time frame: Baseline, 3, 6, 9 and 12 months
Charlson Index
Time frame: Baseline, 3, 6, 9 and 12 months
PPS
Time frame: Baseline, 3, 6, 9 and 12 months
ECOG
Time frame: Baseline, 3, 6, 9 and 12 months
Pfeiffer questionaire
Time frame: Baseline, 3, 6, 9 and 12 months
BPI
Time frame: Baseline, 3, 6, 9 and 12 months
Age
Time frame: Baseline registry
Sex
Time frame: Baseline
Type of cancer
Time frame: Baseline
Stage
Time frame: Baseline
Aim of the onco-specific treatment
Time frame: Baseline
Type of onco-specific treatment
Time frame: Baseline, 3, 6, 9 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- 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.
Jesús González Barboteo, MD, PhD principal investigator
Catalan Institute of Oncology (ICO)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard intervention and E-health intervention in people with Non-Small Cell Lung Cancer, run by Jesús González at 2 sites in Spain.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesús González Barboteo, MD, PhD (932607733 ext. +34, jgonzalez@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACT-L (time frame: Baseline, 3, 6, 9 and 12 months). 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 26 Jun 2025.