Cancer CaregiversNCT03856086
Comparing Distress Screening + Consultation With Enhanced Usual Care for Caregivers of Cancer Patients
A study testing Baseline questionnaire, NCCN Problem List and FACT-GP in people with Cancer Caregivers, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This study will help the researchers find out whether the S+C approach is better, the same as, or worse than EUC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Caregivers
- What is being tested?
- Baseline questionnaire, NCCN Problem List and FACT-GP
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2019to 12 Nov 2025
- 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
- Self-identified caregiver to a patient receiving surgery at JRSC OR self-identified caregiver to a patient at various inpatient surgical floors (i.e., M4, M7, M8) at the Main Hospital OR self-identified caregiver to a patient at the BMT clinic.
- English fluency: Self-report by subject identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English "Very well."
- 18 years old or older as per self report
- Agree to fulfill responsibilities as an IC during the perioperative phases as per self report
Who cannot join
- Cognitive difficulties that preclude participation in the intervention or accurate assessment in the judgment of the PI
- Medical illness that is of sufficient severity to preclude further participation in the study.
- Presenting to JRSC as the IC for a patient undergoing a prophylactic procedure
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: The Impact of Caregiver Distress Screening, Targeted Referral and Consultation on MSK Caregiver, Patient and Health System Outcomes
This study will help the researchers find out whether the S+C approach is better, the same as, or worse than EUC.
- Conditions
- Cancer Caregivers
- Being tested
- Baseline questionnaire, NCCN Problem List, FACT-GP, HADS, CSS-CG
- Keywords
- Comparing Distress Screening, Consultation With Enhanced Usual Care, Supportive care, 18-539
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline questionnaireBehavioural
Baseline questionnaire on the day of the patient's surgery.
NCCN Problem ListBehavioural
NCCN Distress Thermometer
FACT-GPBehavioural
Greater overall quality of life
HADSBehavioural
Lower anxiety and depression
CSS-CGBehavioural
web-based CSS-CG
| Study group | Role | What they receive |
|---|---|---|
| Enhanced usual care (EUC) | Active comparator | ICs randomized to EUC following baseline questionnaire completion will be given instructions (Appendix I) on how to access or create an account to access the myMSK online portal IC Resources page (https://my.mskcc.org/login). If the caregiver does not wish to enroll in MyMSK, the research study staff will send them an email with sample referral material ( Appendix D. The IC Resources page includes links to extant MSK educational materials for ICs (e.g., "A Guide for Caregivers" [47]), contact information for psychosocial services (e.g., Caregivers Clinic in the MSK Counseling Center), and external resources (e.g., educational materials and services through the CSC, American Cancer Society, and others) (Appendix D,). Receives: Behavioral: Baseline questionnaire; Behavioral: NCCN Problem List; Behavioral: FACT-GP; Behavioral: HADS |
| CancerSupportSource-CG screening plus consultation (S+C) | Experimental | ICs randomized to S+C will complete the web-based CSS-CG (Appendix C) using a tablet immediately following baseline study measures. In case of technical issues, ICs may complete Appendix C with the guidance of a member of the research study team. The CSS-CG asks ICs to rate their level of concern for 33 different possible problems: if a need is rated as low (i.e., "A little" or less concern), after each problem is rated ICs will be prompted to request pertinent educational materials if they are interested. If a need is endorsed (i.e., "Moderate" or greater concern), ICs are asked through the web-based electronic platform (https://mskcc.mycarereport.com) whether they would like educational materials and/or to speak with someone about that need (i.e., receive a referral). Receives: Behavioral: Baseline questionnaire; Behavioral: NCCN Problem List; Behavioral: FACT-GP; Behavioral: HADS; Behavioral: CSS-CG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Informal caregivers with unmet needs
comparing the 3-month change scores on the NCCN problem list from baseline
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start25 Feb 2019
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
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 Cancer CaregiversStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized between screening with the CSS-CG + consultation (S+C, and enhanced usual care.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia
- Responsible party
- Sponsor
- Investigators
- Allison Applebaum, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856086
- Sponsor's protocol ID
- 18-539
- Status last verified
- Nov 2025
- First submitted
- 25 Feb 2019
- Last updated
- 14 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Publications
Applebaum AJ, Schofield E, Kastrinos A, Gebert R, Behrens M, Loschiavo M, Shaffer KM, Levine M, Dannaoui A, Bellantoni C, Miller MF, Zaleta AK. A randomized controlled trial of a distress screening, consultation, and targeted referral system for family caregivers in oncologic care. Psychooncology. 2024 Feb;33(2):e6301. doi: 10.1002/pon.6301.
PubMed 38363002
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Caregiver Distress Screening, Targeted Referral and Consultation on MSK Caregiver, Patient and Health System Outcomes
- ClinicalTrials.gov ID
- NCT03856086
- Acronym / sponsor ID
- 18-539
- Conditions
- Cancer Caregivers
- Keywords
- Comparing Distress Screening, Consultation With Enhanced Usual Care, Supportive care, 18-539
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- University of Virginia
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 27 Feb 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.
This study will help the researchers find out whether the S+C approach is better, the same as, or worse than EUC.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized between screening with the CSS-CG + consultation (S+C, and enhanced usual care.
| Arm | Type | Receives |
|---|---|---|
| Enhanced usual care (EUC) | Active comparator | Behavioral: Baseline questionnaire, Behavioral: NCCN Problem List, Behavioral: FACT-GP, Behavioral: HADSICs randomized to EUC following baseline questionnaire completion will be given instructions (Appendix I) on how to access or create an account to access the myMSK online portal IC Resources page (https://my.mskcc.org/login). If the caregiver does not wish to enroll in MyMSK, the research study staff will send them an email with sample referral material ( Appendix D. The IC Resources page includes links to extant MSK educational materials for ICs (e.g., "A Guide for Caregivers" [47]), contact information for psychosocial services (e.g., Caregivers Clinic in the MSK Counseling Center), and external resources (e.g., educational materials and services through the CSC, American Cancer Society, and others) (Appendix D,). |
| CancerSupportSource-CG screening plus consultation (S+C) | Experimental | Behavioral: Baseline questionnaire, Behavioral: NCCN Problem List, Behavioral: FACT-GP, Behavioral: HADS, Behavioral: CSS-CGICs randomized to S+C will complete the web-based CSS-CG (Appendix C) using a tablet immediately following baseline study measures. In case of technical issues, ICs may complete Appendix C with the guidance of a member of the research study team. The CSS-CG asks ICs to rate their level of concern for 33 different possible problems: if a need is rated as low (i.e., "A little" or less concern), after each problem is rated ICs will be prompted to request pertinent educational materials if they are interested. If a need is endorsed (i.e., "Moderate" or greater concern), ICs are asked through the web-based electronic platform (https://mskcc.mycarereport.com) whether they would like educational materials and/or to speak with someone about that need (i.e., receive a referral). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-identified caregiver to a patient receiving surgery at JRSC OR self-identified caregiver to a patient at various inpatient surgical floors (i.e., M4, M7, M8) at the Main Hospital OR self-identified caregiver to a patient at the BMT clinic.
- English fluency: Self-report by subject identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English "Very well."
- 18 years old or older as per self report
- Agree to fulfill responsibilities as an IC during the perioperative phases as per self report
Key exclusion criteria (3 listed)
- Cognitive difficulties that preclude participation in the intervention or accurate assessment in the judgment of the PI
- Medical illness that is of sufficient severity to preclude further participation in the study.
- Presenting to JRSC as the IC for a patient undergoing a prophylactic procedure
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 |
|---|---|---|
| Baseline questionnaireBaseline questionnaire on the day of the patient's surgery. | Behavioural | CancerSupportSource-CG screening plus consultation (S+C), Enhanced usual care (EUC) |
| NCCN Problem ListNCCN Distress Thermometer | Behavioural | CancerSupportSource-CG screening plus consultation (S+C), Enhanced usual care (EUC) |
| FACT-GPGreater overall quality of life | Behavioural | CancerSupportSource-CG screening plus consultation (S+C), Enhanced usual care (EUC) |
| HADSLower anxiety and depression | Behavioural | CancerSupportSource-CG screening plus consultation (S+C), Enhanced usual care (EUC) |
| CSS-CGweb-based CSS-CG | Behavioural | CancerSupportSource-CG screening plus consultation (S+C) |
Primary outcome
Number of Informal caregivers with unmet needs
Time frame: 1 year
comparing the 3-month change scores on the NCCN problem list from baseline
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 14 Nov 2025.
- Derived from this study: PubMed 38363002Applebaum AJ, Schofield E, Kastrinos A, Gebert R, Behrens M, Loschiavo M, Shaffer KM, Levine M, Dannaoui A, Bellantoni C, Miller MF, Zaleta AK. A randomized controlled trial of a distress screening, consultation, and targeted referral system for family caregivers in oncologic care. Psychooncology. 2024 Feb;33(2):e6301. doi: 10.1002/pon.6301.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Allison Applebaum, PhD 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?
A study testing Baseline questionnaire, NCCN Problem List and FACT-GP in people with Cancer Caregivers, 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: finished, as of the sponsor's last update on 14 Nov 2025. 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?
Number of Informal caregivers with unmet needs (time frame: 1 year). 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 NCT03856086, 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 14 Nov 2025.