Culturally Tailored Nurse Coaching Study for Cancer Symptom Management

Not Applicable

Completed

• Conditions: Symptom Cluster; Chemotherapy Effect; Dehydration; Quality of Life; Self Efficacy
• Interventions: Behavioral: CTNSM; Behavioral: Standard of Care Chemotherapy Education

• Registration Number: NCT04874584
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-30
• Study First Submitted QC: 2021-04-30
• Study First Posted: 2021-05-05
• Study Start: 2021-10-27
• Status Verified: 2023-05
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTNSM Group	Standard of Care Chemotherapy Education	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.
Standard of Care (control) Group	Standard of Care Chemotherapy Education	Participants in the control group will only be receiving the standard of care chemotherapy education.
CTNSM Group	CTNSM	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.

Primary Outcome Measures

Name	Time	Method
Change in MDASI scores	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.
Incidents of dehydration	up to 12 weeks	Incidents of unscheduled medical visits for IV hydration

Secondary Outcome Measures

Name	Time	Method
change in Partners in Health Scale (PIHS) scores	baseline, up to 12 weeks	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.
Change in FACT-C Scores	baseline, up to 12 weeks	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.
change in Chronic Disease Self-Efficacy Scale (CDSES) scores	baseline, up to 12 weeks	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.
Change in FACT-B Scores	baseline, up to 12 weeks	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.
Change in FACT-P Scores	baseline, up to 12 weeks	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.
Change in FACT-LC Scores	baseline, up to 12 weeks	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.
Percentage of completed call or text message	up to 12 weeks	Feasibility will be reported as a percentage of completed calls or text messages.

Trial Locations

Locations (1)

University of Miami Sylvester Comprehensive Cancer Ctr.; 🇺🇸 Miami, Florida, United States