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| Name | Class |
|---|---|
| Oncology Nursing Society | OTHER |
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The purpose of the study is to see whether or not a telephone/ text message intervention, delivered by a registered nurse, is helpful in managing symptoms and can also prevent dehydration caused by chemotherapy treatment when given together for patients with metastatic breast, colon, lung or prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTNSM Group | Experimental | Culturally Tailored Nurse Symptom Management group (CTNSM) - participants in the CTNSM group will receive one in-person or telehealth face-to-face education session followed by a weekly telephone call and/or text message during the first 12 weeks of standard of care chemotherapy. In addition, participants can receive standard of care chemotherapy education. |
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| Standard of Care (control) Group | Active Comparator | Participants in the control group will only be receiving the standard of care chemotherapy education. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTNSM | Behavioral | The Culturally Tailored Nurse-delivered telephone/text message symptom-management intervention (CTNSM) intervention is an in-person or telehealth face-to-face education session followed by a weekly telephone call and/or text message conducted for the first 12 weeks of standard of care chemotherapy . |
| Measure | Description | Time Frame |
|---|---|---|
| Change in MDASI scores | MD Anderson Symptom Inventory (MDASI) is a 19 item scale with a score range from 0-10 per symptom question that measures symptom severity plus symptom interference combined to measure total symptom burden. The higher score indicates worsening of symptoms. | baseline, up to 12 weeks |
| Incidents of dehydration | Incidents of unscheduled medical visits for IV hydration | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in Chronic Disease Self-Efficacy Scale (CDSES) scores | The CDSES is a 10 item scale with a score range from 0-10 per symptom question that measures perceived self-efficacy. The higher score indicates better perceived self-efficacy. | baseline, up to 12 weeks |
| change in Partners in Health Scale (PIHS) scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natasha Solle, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Ctr. | Miami | Florida | 33136 | United States |
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| Label | URL |
|---|---|
| Nurse-Delivered Telephone Intervention to Reduce Oral Mucositis and Prevent Dehydration | View source |
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| ID | Term |
|---|---|
| D003681 | Dehydration |
| D013577 | Syndrome |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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| Standard of Care Chemotherapy Education | Behavioral | Standard of Care chemotherapy education is a one-time patient education session about general treatment-related side effects patients can experience from chemotherapy and the interventions to mitigate the symptoms. |
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The PIHS is a 12 item scale with a score range from 0-8 per question that measures symptoms self-management. The higher score indicates better symptom self-management. |
| baseline, up to 12 weeks |
| Percentage of completed call or text message | Feasibility will be reported as a percentage of completed calls or text messages. | up to 12 weeks |
| Change in FACT-B Scores | Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Breast (FACT-B). FACT-B has a total scoring of 0-148 with the higher scoring indicating better HRQoL. | baseline, up to 12 weeks |
| Change in FACT-P Scores | Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Prostate (FACT-P). FACT-P has a total scoring of 0-156 with the higher scoring indicating better HRQoL. | baseline, up to 12 weeks |
| Change in FACT-C Scores | Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Colon (FACT-C). FACT-C has a total scoring of 0-144 with the higher scoring indicating better HRQoL. | baseline, up to 12 weeks |
| Change in FACT-LC Scores | Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Lung Cancer (FACT-LC). FACT-LC has a total scoring of 0-144 with the higher scoring indicating better HRQoL. | baseline, up to 12 weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004194 | Disease |