Distress Screening + Consultation for Cancer Caregivers
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.12345Why 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.16789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Caregivers complete the CSS-CG screening and consultation or receive enhanced usual care
Follow-up
Participants are monitored for changes in unmet needs and other outcomes
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?
2
Treatment groups
Experimental Treatment
Active Control
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).
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,).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
University of Virginia
Collaborator
Citations
1.
cancersupportcommunity.org
cancersupportcommunity.org/sites/default/files/file/2022-04/2022_NCCN_CSS-CG_Development_FINAL.pdfCancerSupportSource®-Caregiver
In its full program implementation, CSS-CG can facilitate distress screening, referral, and follow-up to rapidly assess caregivers' unmet needs ...
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), ...
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_CaregiversDevelopment 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 ...
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 ...
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 ...
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.pdfCancerSupportSourceTM‐Caregiver
CancerSupportSourceTM‐Caregiver is a distress screening, referral, and support program designed to identify the unmet needs of cancer caregivers and link care-.
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% ...
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