Culturally Tailored Nurse Coaching Study for Cancer Symptom Management

Quality of Life Clinical Trial

Official title:

Utilizing a Culturally Tailored Nurse Coaching Intervention to Decrease Symptom Severity and Prevent Dehydration in Patients With Metastatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04874584
• Other study ID #: 20201491
• Status: Completed
• Phase: N/A
• Start date: October 27, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: May 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy Effect
• Dehydration
• Quality of Life
• Self Efficacy
• Symptom Cluster
• Syndrome

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Miami Sylvester Comprehensive Cancer Ctr.	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Oncology Nursing Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidents of dehydration	Incidents of unscheduled medical visits for IV hydration	up to 12 weeks
Secondary	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
Secondary	change in Partners in Health Scale (PIHS) scores	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
Secondary	Percentage of completed call or text message	Feasibility will be reported as a percentage of completed calls or text messages.	up to 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Nurse-Delivered Telephone Intervention to Reduce Oral Mucositis and Prevent Dehydration