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

150 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Distress Screening + Consultation for Cancer Caregivers?

Research shows that distress screening is beneficial for improving the quality of life and outcomes for cancer patients by allowing for timely referrals to appropriate interventions. This suggests that similar screening and consultation programs for caregivers could also be effective in managing distress. ^{1 2 3 4 5}

Is distress screening safe for cancer caregivers?

The research on distress screening programs, like CancerSupportSource®, shows they are generally safe and beneficial for improving quality of life by identifying distress and allowing for appropriate support, though specific safety data for caregivers is not detailed. ^{1 4 5 6 7}

How is the treatment CSS-CG for cancer caregivers different from other treatments?

CSS-CG is unique because it focuses on distress screening and consultation specifically for cancer caregivers, addressing their emotional and psychological needs, which is often overlooked in standard cancer care treatments that primarily focus on patients. ^{1 2 4 8 9}

What is the purpose of this trial?

This study will help the researchers find out whether the S+C approach is better, the same as, or worse than EUC.

Research Team

Allison Applebaum, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Not seeing the forest for the trees: a systematic review of comprehensive distress management programs and implementation strategies. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Distress Screening for Family Caregivers at a Cancer Surgery Center. [2022]

3. England pubmed.ncbi.nlm.nih.gov

What do 1281 distress screeners tell us about cancer patients in a community cancer center? [2011]

4. United States pubmed.ncbi.nlm.nih.gov

Disparities in managing emotions when facing a diagnosis of breast cancer: Results of screening program of couples distress. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Screening for distress in patients with cancer. [2014]

6. Germany pubmed.ncbi.nlm.nih.gov

CancerSupportSource®-15+: development and evaluation of a short form of a distress screening program for cancer patients and survivors. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Brief Distress Screening in Clinical Practice: Does it Help to Effectively Allocate Psycho-Oncological Support to Female Cancer Inpatients? [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Distress, Depression, and the Effect of ZIP Code in Pancreaticobiliary Cancer Patients and Their Significant Others. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Development and implementation of a comprehensive psychosocial screening program in a Brazilian cancer center. [2018]