Metastatic Solid Tumor CancersNCT03667378
Investigating the Impact of Proactive Palliative Care
An observational study of Metastatic Solid Tumor Cancers and Locally Advanced Solid Tumor Cancers, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This study will test whether adding personalized supportive care to medical treatment on a clinical trial affects the study participants' ability and desire to discuss their symptoms, their concerns about the future, and their approach to coping with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumor Cancers, Locally Advanced Solid Tumor Cancers
- What is being tested?
- Expectations Survey (CanCORS), Values Survey (Serious Illness Care Program) and Functional Assessment of Cancer Therapy-General (FACT-G)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2018to Sep 2027
- Phase
- Observational
- 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
Study population: The study population will be patients with metastatic or locally advanced solid tumor cancers who progress beyond standard treatment and are deemed eligible to receive treatment with investigational targeted or immune-based therapeutics with Phase I, Phase I/Ib, and Phase I/II trials at MSK.
Who may be able to join
- Patients with disease progression on at least one standard chemotherapy regimen, and now eligible and consented to begin Phase I, Phase I/Ib, Phase I/II and non-randomized Phase II (including basket studies) investigational targeted and immune-based therapeutics in MSK medical oncology, EDD, or ITC clinics
- Able to speak, read, and understand English well enough to complete study assessments in the judgment of the consenting professional
- 18 years of age and older
- Has a progressive or metastatic solid tumor cancer with MSK pathology confirmation at the primary or metastatic anatomic site
Who cannot join
- Patients who already are receiving specialty supportive care (already referred for a supportive care consultation) prior to enrollment in a Phase I protocol.
- Patients will be excluded if the Phase I, Phase I/Ib, Phase I/II or Phase II trial involves known active drugs in combination with experimental drugs, in which the patient has not previously received the known active drug or active drugs of the same class. For example, a patient with metastatic pancreatic cancer who has not received gemcitabine/nab-paclitaxel, but enrolls on a study that tests an experimental drug in addition to gemcitabine/nab-paclitaxel, will be excluded.
- Significant psychiatric or cognitive disturbance in the primary clinician"s or investigator"s judgment, to preclude providing informed consent or participating in the interventions (i.e. acute psychiatric symptoms which require individual treatment)
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Evaluating the Impact of Proactive Palliative Care in Patients Initiating Phase I Targeted or Immune-Based Cancer Therapeutics: A Randomized Controlled Trial
This study will test whether adding personalized supportive care to medical treatment on a clinical trial affects the study participants' ability and desire to discuss their symptoms, their concerns about the future, and their approach to coping with cancer. The effects of supportive care on participants' responses to questions about these topics will be compared with those of other study participants who are being treated for cancer in a clinical trial, but are not receiving personalized supportive care.
- Being tested
- Expectations Survey (CanCORS), Values Survey (Serious Illness Care Program), Functional Assessment of Cancer Therapy-General (FACT-G), NCCN Distress Thermometer, Hospital Anxiety and Depression Scale (HADS)
- Keywords
- Quality of Life, Supportive Care, 18-363
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expectations Survey (CanCORS)Behavioural
Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).
Values Survey (Serious Illness Care Program)Behavioural
Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).
Functional Assessment of Cancer Therapy-General (FACT-G)Behavioural
Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).
NCCN Distress ThermometerBehavioural
Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).
Hospital Anxiety and Depression Scale (HADS)Behavioural
Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).
Quality of Communication (QOC)Behavioural
Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).
visits with a supportive care clinicianBehavioural
Monthly visits with a supportive care clinician
| Study group | Role | What they receive |
|---|---|---|
| supportive care visits | A concurrent supportive care intervention (intervention arm) Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).intervention arm will have at least monthly visits with a supportive care clinician Receives: Behavioral: Expectations Survey (CanCORS); Behavioral: Values Survey (Serious Illness Care Program); Behavioral: Functional Assessment of Cancer Therapy-General (FACT-G); Behavioral: NCCN Distress Thermometer; Behavioral: Hospital Anxiety and Depression Scale (HADS); Behavioral: Quality of Communication (QOC); Behavioral: visits with a supportive care clinician | |
| without supportive care visits | A concurrent supportive care intervention (intervention arm) Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).intervention arm will have at least monthly visits with a supportive care clinicianTo receive the investigational cancer treatment alone (control arm) no monthly visit with a supportive care clinician. Receives: Behavioral: Expectations Survey (CanCORS); Behavioral: Values Survey (Serious Illness Care Program); Behavioral: Functional Assessment of Cancer Therapy-General (FACT-G); Behavioral: NCCN Distress Thermometer; Behavioral: Hospital Anxiety and Depression Scale (HADS); Behavioral: Quality of Communication (QOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients' expectations for therapeutic benefit
using the CanCORS Expectations Survey, which will assess, on a 4-point Likert-type scale, patients' expectations for therapeutic benefit after talking with their doctors about their experimental drug
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start7 Sep 2018
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Solid Tumor CancersStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Epstein, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667378
- Sponsor's protocol ID
- 18-363
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2018
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Proactive Palliative Care in Patients Initiating Phase I Targeted or Immune-Based Cancer Therapeutics: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03667378
- Acronym / sponsor ID
- 18-363
- Keywords
- Quality of Life, Supportive Care, 18-363
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 12 Sep 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.
This study will test whether adding personalized supportive care to medical treatment on a clinical trial affects the study participants' ability and desire to discuss their symptoms, their concerns about the future, and their approach to coping with cancer. The effects of supportive care on participants' responses to questions about these topics will be compared with those of other study participants who are being treated for cancer in a clinical trial, but are not receiving personalized supportive care.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supportive care visits | – | Behavioral: Expectations Survey (CanCORS), Behavioral: Values Survey (Serious Illness Care Program), Behavioral: Functional Assessment of Cancer Therapy-General (FACT-G), Behavioral: NCCN Distress Thermometer, Behavioral: Hospital Anxiety and Depression Scale (HADS), Behavioral: Quality of Communication (QOC), Behavioral: visits with a supportive care clinicianA concurrent supportive care intervention (intervention arm) Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).intervention arm will have at least monthly visits with a supportive care clinician |
| without supportive care visits | – | Behavioral: Expectations Survey (CanCORS), Behavioral: Values Survey (Serious Illness Care Program), Behavioral: Functional Assessment of Cancer Therapy-General (FACT-G), Behavioral: NCCN Distress Thermometer, Behavioral: Hospital Anxiety and Depression Scale (HADS), Behavioral: Quality of Communication (QOC)A concurrent supportive care intervention (intervention arm) Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).intervention arm will have at least monthly visits with a supportive care clinicianTo receive the investigational cancer treatment alone (control arm) no monthly visit with a supportive care clinician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be patients with metastatic or locally advanced solid tumor cancers who progress beyond standard treatment and are deemed eligible to receive treatment with investigational targeted or immune-based therapeutics with Phase I, Phase I/Ib, and Phase I/II trials at MSK.
Key inclusion criteria (4 listed)
- Patients with disease progression on at least one standard chemotherapy regimen, and now eligible and consented to begin Phase I, Phase I/Ib, Phase I/II and non-randomized Phase II (including basket studies) investigational targeted and immune-based therapeutics in MSK medical oncology, EDD, or ITC clinics
- Able to speak, read, and understand English well enough to complete study assessments in the judgment of the consenting professional
- 18 years of age and older
- Has a progressive or metastatic solid tumor cancer with MSK pathology confirmation at the primary or metastatic anatomic site
Key exclusion criteria (3 listed)
- Patients who already are receiving specialty supportive care (already referred for a supportive care consultation) prior to enrollment in a Phase I protocol.
- Patients will be excluded if the Phase I, Phase I/Ib, Phase I/II or Phase II trial involves known active drugs in combination with experimental drugs, in which the patient has not previously received the known active drug or active drugs of the same class. For example, a patient with metastatic pancreatic cancer who has not received gemcitabine/nab-paclitaxel, but enrolls on a study that tests an experimental drug in addition to gemcitabine/nab-paclitaxel, will be excluded.
- Significant psychiatric or cognitive disturbance in the primary clinician"s or investigator"s judgment, to preclude providing informed consent or participating in the interventions (i.e. acute psychiatric symptoms which require individual treatment)
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 |
|---|---|---|
| Expectations Survey (CanCORS)Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2). | Behavioural | supportive care visits, without supportive care visits |
| Values Survey (Serious Illness Care Program)Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2). | Behavioural | supportive care visits, without supportive care visits |
| Functional Assessment of Cancer Therapy-General (FACT-G)Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2). | Behavioural | supportive care visits, without supportive care visits |
| NCCN Distress ThermometerStudy assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2). | Behavioural | supportive care visits, without supportive care visits |
| Hospital Anxiety and Depression Scale (HADS)Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2). | Behavioural | supportive care visits, without supportive care visits |
| Quality of Communication (QOC)Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2). | Behavioural | supportive care visits, without supportive care visits |
| visits with a supportive care clinicianMonthly visits with a supportive care clinician | Behavioural | supportive care visits |
Primary outcome
patients' expectations for therapeutic benefit
Time frame: 3 months
using the CanCORS Expectations Survey, which will assess, on a 4-point Likert-type scale, patients' expectations for therapeutic benefit after talking with their doctors about their experimental drug
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 5 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Andrew Epstein, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Solid Tumor Cancers and Locally Advanced Solid Tumor Cancers, run by Memorial Sloan Kettering Cancer Center 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 4 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. 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?
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?
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?
patients' expectations for therapeutic benefit (time frame: 3 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 5 Oct 2026.