Culturally Tailored Nurse Coaching Study for Cancer Symptom Management

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Dehydration; Chemotherapy Effect; Self Efficacy; Symptom Cluster
• Intervention / Treatment: Behavioral: CTNSM; Behavioral: Standard of Care Chemotherapy Education

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Sylvester Comprehensive Cancer Ctr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 .; Behavioral: 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.
Active Comparator: Standard of Care (control) Group; Participants in the control group will only be receiving the standard of care chemotherapy education.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Oncology Nursing Society
• Investigators: Principal Investigator: Natasha Solle, PhD, University of Miami

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: symptom severity; emotional support; symptom self-management
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease; Water-Electrolyte Imbalance; Syndrome; Dehydration
• Other Study ID Numbers: 20201491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No