Culturally Tailored Nurse Coaching Study for Cancer Symptom Management

University of Miami

Status: Completed

Conditions: Symptom Cluster; Chemotherapy Effect; Self Efficacy; Dehydration; Quality of Life

Treatments: Behavioral: CTNSM; Behavioral: Standard of Care Chemotherapy Education

Study type: Interventional

Funder types: Other

Identifiers

NCT04874584

20201491

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

CTNSM Group

Experimental group

Description:

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.

Treatment:

Behavioral: CTNSM

Behavioral: Standard of Care Chemotherapy Education

Standard of Care (control) Group

Active Comparator group

Description:

Participants in the control group will only be receiving the standard of care chemotherapy education.

Treatment:

Behavioral: Standard of Care Chemotherapy Education