Clinical trial NCT04874584: Culturally Tailored Nurse Coaching Study for Cancer Symptom Management
Official title: Utilizing a Culturally Tailored Nurse Coaching Intervention to Decrease Symptom Severity and Prevent Dehydration in Patients With Metastatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration
Symptom Cluster
Quality of Life
Self Efficacy
Chemotherapy Effect
Keywords: symptom self-management
symptom severity
emotional support
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Oncology Nursing Society
First posted: 2021-05-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

1. Eligible for Chemotherapy for the first time (Previous \& Ongoing hormonal only treatment allowed OR Neoadjuvant \& Adjuvant chemotherapy regimens with 2+ drugs allowed)
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:

1. Patients on immunotherapy only will be excluded
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

Primary outcomes:
measure: Change in MDASI scores
timeFrame: baseline, up to 12 weeks
measure: Incidents of dehydration
timeFrame: up to 12 weeks
Secondary outcomes:
measure: change in Chronic Disease Self-Efficacy Scale (CDSES) scores
timeFrame: baseline, up to 12 weeks
measure: change in Partners in Health Scale (PIHS) scores
timeFrame: baseline, up to 12 weeks
measure: Percentage of completed call or text message
timeFrame: up to 12 weeks
measure: Change in FACT-B Scores
timeFrame: baseline, up to 12 weeks
measure: Change in FACT-P Scores
timeFrame: baseline, up to 12 weeks
measure: Change in FACT-C Scores
timeFrame: baseline, up to 12 weeks
measure: Change in FACT-LC Scores
timeFrame: baseline, up to 12 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Ctr.
state: Florida
Study officials:
affiliation: University of Miami
name: Natasha Solle, PhD
role: PRINCIPAL_INVESTIGATOR
References: