Culturally Tailored Nurse Coaching Study for Cancer Symptom Management

NCT04874584 | Completed

• 1 other identifier: 20201491
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

symptom self-management; symptom severity; emotional support

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• change in Chronic Disease Self-Efficacy Scale (CDSES) scores

  baseline, up to 12 weeks

• change in Partners in Health Scale (PIHS) scores

  baseline, up to 12 weeks

• Percentage of completed call or text message

  up to 12 weeks

• Change in FACT-B Scores

  baseline, up to 12 weeks

• Change in FACT-P Scores

  baseline, up to 12 weeks

Study Arms (2)

CTNSM Group

EXPERIMENTAL

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; Behavioral: Standard of Care Chemotherapy Education

Standard of Care (control) Group

ACTIVE COMPARATOR

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

Behavioral: Standard of Care Chemotherapy Education

Interventions

CTNSM BEHAVIORAL

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 .

CTNSM Group

Standard of Care Chemotherapy Education BEHAVIORAL

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.

CTNSM Group; Standard of Care (control) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible for Chemotherapy for the first time (Previous \& Ongoing hormonal only treatment allowed OR Neoadjuvant \& Adjuvant chemotherapy regimens with 2+ drugs allowed)
• \> 18 years old
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• There are no life expectancy restrictions
• Women of child-bearing potential are allowed in the study as long as they are eligible for the chemotherapy treatment.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Patients on immunotherapy only will be excluded
• Previous chemotherapy
• Under 18 years old
• 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.
• No access to a telephone
• 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

Sponsors & Collaborators

• University of Miami: lead
• Oncology Nursing Society: collaborator

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Ctr.

Miami, Florida, 33136, United States

Location

Related Links

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

MeSH Terms

Conditions

Dehydration; Syndrome

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease

Study Officials

• Natasha Solle, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant research professor

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 5, 2021
• Study Start: October 27, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)