Culturally Tailored Nurse Coaching Study for Cancer Symptom Management
NCT ID: NCT04874584
Last Updated: 2023-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2021-10-27
2023-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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CTNSM Group
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.
CTNSM
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 .
Standard of Care Chemotherapy Education
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.
Standard of Care (control) Group
Participants in the control group will only be receiving the standard of care chemotherapy education.
Standard of Care Chemotherapy Education
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.
Interventions
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CTNSM
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 .
Standard of Care Chemotherapy Education
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.
Eligibility Criteria
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Inclusion Criteria
2. \> 18 years old
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
4. There are no life expectancy restrictions
5. Women of child-bearing potential are allowed in the study as long as they are eligible for the chemotherapy treatment.
6. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
2. Previous chemotherapy
3. Under 18 years old
4. Medically Diagnosed with a Cognitive Impairment. Rationale for excluding people with cognitive impairment is that they would not be able to fully participate in the self-management care aspects of the intervention via the telephone, nor provide informed consent.
5. No access to a telephone
6. Blind or Deaf; If subject is Hearing-impaired or illiterate, then the subject may have a family member participate as a telecommunication surrogate with them in the study
18 Years
ALL
No
Sponsors
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Oncology Nursing Society
OTHER
University of Miami
OTHER
Responsible Party
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Natasha Solle, PhD, RN
assistant research professor
Principal Investigators
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Natasha Solle, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami Sylvester Comprehensive Cancer Ctr.
Miami, Florida, United States
Countries
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Related Links
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Nurse-Delivered Telephone Intervention to Reduce Oral Mucositis and Prevent Dehydration
Other Identifiers
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20201491
Identifier Type: -
Identifier Source: org_study_id
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