Distress Screening + Consultation for Cancer Caregivers

Overseen By Allison Applebaum, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Cognitive difficulties, Severe medical illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new support method for cancer caregivers is more effective than the usual care. Participants will either receive a personalized consultation and screening (CSS-CG) to address their concerns or access standard educational materials and resources. The trial aims to determine if the personalized approach better supports caregivers' needs. Ideal participants are those currently caring for someone undergoing surgery or treatment in specific hospital settings and who can speak English fluently. As an unphased trial, this study offers caregivers a unique opportunity to contribute to innovative support methods that could enhance caregiver well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the S+C approach is safe for cancer caregivers?

Research shows that the CancerSupportSource-Caregiver (CSS-CG) reliably checks stress levels in those caring for cancer patients. Studies have found it valid for identifying caregivers' needs and connecting them with support and referrals. Importantly, no serious side effects have been reported from its use. This tool has been developed and tested to ensure safety and effectiveness in helping caregivers manage stress and access necessary resources.

In trials like this one, the focus is on how well the intervention is tolerated. The "Not Applicable" phase label indicates that the intervention is not a new drug or high-risk treatment with unknown side effects. Instead, it evaluates the effectiveness of the support and resources provided to caregivers. Participants can feel confident that the CSS-CG is designed with their well-being in mind. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Distress Screening + Consultation for Cancer Caregivers trial because it introduces a personalized approach to supporting caregivers. Unlike standard resources that caregivers must seek out independently, this method actively screens for specific concerns using the web-based CSS-CG tool and offers tailored educational materials and referrals. This proactive and customized support mechanism empowers caregivers by addressing their unique needs promptly, potentially improving their overall well-being and ability to care for their loved ones.

What evidence suggests that this trial's treatments could be effective for cancer caregivers?

Research has shown that the CancerSupportSource-Caregiver (CSS-CG) program, which participants in this trial may receive, can help caregivers of cancer patients by identifying and addressing their unmet needs. Past studies have found CSS-CG promising in improving emotional well-being and reducing stress by offering specific support and resources. This trial will compare the CSS-CG program with Enhanced Usual Care (EUC), which provides caregivers with access to educational materials and resources. The CSS-CG program assesses caregivers for distress and offers advice and referrals based on their specific concerns. This approach aims to enhance caregivers' ability to support their loved ones while maintaining their own well-being. Early evidence suggests that CSS-CG can positively impact caregivers' lives by providing the right resources and support when needed. ^{1 6 7 8 9}

Who Is on the Research Team?

Allison Applebaum, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adults who identify as caregivers to cancer patients undergoing surgery or treatment at specified hospital locations. They must be able to fulfill caregiver responsibilities during the perioperative phases and not have cognitive difficulties or severe medical illnesses that could interfere with participation.

Inclusion Criteria

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.

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.

Agree to fulfill responsibilities as an IC during the perioperative phases as per self report

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Caregivers complete the CSS-CG screening and consultation or receive enhanced usual care

3 months

Follow-up

Participants are monitored for changes in unmet needs and other outcomes

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Baseline questionnaire
• CSS-CG
• FACT-GP
• HADS
• NCCN Problem List

Trial Overview The study compares two approaches: Distress Screening + Consultation (S+C) versus Enhanced Usual Care (EUC) for caregivers of cancer patients. It aims to determine if S+C offers any benefits over EUC in managing caregiver distress.

How Is the Trial Designed?

Group I: CancerSupportSource-CG screening plus consultation (S+C) Experimental Treatment 5 Interventions

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).

Group II: Enhanced usual care (EUC) Active Control 4 Interventions

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,).

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

Citations

1. cancersupportcommunity.org cancersupportcommunity.org/sites/default/files/file/2022-04/2022_NCCN_CSS-CG_Development_FINAL.pdf

CancerSupportSource®-Caregiver In its full program implementation, CSS-CG can facilitate distress screening, referral, and follow-up to rapidly assess caregivers' unmet needs ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38363002/

A randomized controlled trial of a distress screening ... - PubMed The objective of this study was to demonstrate the feasibility, acceptability, and preliminary efficacy of Cancer Support Source-CaregiverTM (CSS-CG, 33-item), ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/pon.6301

A randomized controlled trial of a distress screening ... The objective of this study was to demonstrate the feasibility, acceptability, and preliminary efficacy of Cancer Support Source-CaregiverTM ( ...

4. researchgate.net researchgate.net/publication/366917288_CancerSupportSourceTM-Caregiver_Development_of_a_Distress_Screening_Measure_for_Cancer_Caregivers

Development of a Distress Screening Measure for Cancer ... Items represented five domains of caregiver concerns: emotional well-being, patient well-being, caregiving tasks, finances, and healthy ...

5. synapse.mskcc.org synapse.mskcc.org/synapse/works/213956

A randomized controlled trial of a distress screening ... A randomized controlled trial of a distress screening, consultation, and targeted referral system for family caregivers in oncologic care ...

6. jnccn.org jnccn.org/view/journals/jnccn/20/3.5/article-pHSR22-181.xml

HSR22-181: CancerSupportSource®-Caregiver ... RESULTS: Participants were 81% women; Mean Age=51.1 (range=20-89; 16% age 65+); 83% Non-Hispanic White, 6% Hispanic; 64% current caregivers. 42 ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/pon.6092

Development of a distress screening measure for cancer ... CancerSupportSource-Caregiver is a reliable and valid multidimensional measure of caregiver distress that also screens for risk for clinically significant ...

8. cancersupportcommunity.org cancersupportcommunity.org/sites/default/files/file/2023-02/Psycho-Oncology%20-%202023%20-%20Zaleta%20-%20CancerSupportSourceTM%E2%80%90Caregiver%20%20Development%20of%20a%20distress%20screening%20measure%20for%20cancer.pdf

CancerSupportSourceTM‐Caregiver CancerSupportSourceTM‐Caregiver is a distress screening, referral, and support program designed to identify the unmet needs of cancer caregivers and link care-.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12179453/

Family-Reported Outcomes Measures (FROMs) Screening ... Full adherence (defined as ≥ 80% of FROMs completed) was achieved by 18% of caregivers, 32% were partially adherent (33-79% completed), and 50% ...