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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04874584
Other study ID # 20201491
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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