Utilizing a Culturally Tailored Nurse Coaching Intervention to Decrease Symptom Severity and Prevent Dehydration in Patients With Metastatic Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dehydration
- Sponsor
- University of Miami
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Incidents of dehydration
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Natasha Solle, PhD, RN
assistant research professor
University of Miami
Eligibility Criteria
Inclusion Criteria
- •Eligible for Chemotherapy for the first time (Previous \& Ongoing hormonal only treatment allowed OR Neoadjuvant \& Adjuvant chemotherapy regimens with 2+ drugs allowed)
- •\> 18 years old
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •There are no life expectancy restrictions
- •Women of child-bearing potential are allowed in the study as long as they are eligible for the chemotherapy treatment.
- •Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- •Patients on immunotherapy only will be excluded
- •Previous chemotherapy
- •Under 18 years old
- •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.
- •No access to a telephone
- •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
Outcomes
Primary Outcomes
Incidents of dehydration
Time Frame: up to 12 weeks
Incidents of unscheduled medical visits for IV hydration
Change in MDASI scores
Time Frame: baseline, up to 12 weeks
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.
Secondary Outcomes
- change in Partners in Health Scale (PIHS) scores(baseline, up to 12 weeks)
- Change in FACT-C Scores(baseline, up to 12 weeks)
- change in Chronic Disease Self-Efficacy Scale (CDSES) scores(baseline, up to 12 weeks)
- Change in FACT-B Scores(baseline, up to 12 weeks)
- Change in FACT-P Scores(baseline, up to 12 weeks)
- Change in FACT-LC Scores(baseline, up to 12 weeks)
- Percentage of completed call or text message(up to 12 weeks)