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| Name | Class |
|---|---|
| University of Virginia | OTHER |
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This study will help the researchers find out whether the S+C approach is better, the same as, or worse than EUC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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,). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baseline questionnaire | Behavioral | Baseline questionnaire on the day of the patient's surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Informal caregivers with unmet needs | comparing the 3-month change scores on the NCCN problem list from baseline | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allison Applebaum, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| C018209 | 4-amino-4'-hydroxylaminodiphenylsulfone |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Participants will be randomized between screening with the CSS-CG + consultation (S+C, and enhanced usual care.
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| NCCN Problem List | Behavioral | NCCN Distress Thermometer |
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| FACT-GP | Behavioral | Greater overall quality of life |
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| HADS | Behavioral | Lower anxiety and depression |
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| CSS-CG | Behavioral | web-based CSS-CG |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |