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Completed

NCT Number: NCT04874584

Culturally Tailored Nurse Coaching Study for Cancer Symptom Management

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.

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Key information

Conditions

Dehydration Chemotherapy Effect Disease Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Self Efficacy Symptom Cluster Syndrome Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Sylvester Comprehensive Cancer Ctr.

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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 .

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.

Primary outcomes

  1. Change in MDASI scores

    Time frame: 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.

  2. Incidents of dehydration

    Time frame: up to 12 weeks

    Incidents of unscheduled medical visits for IV hydration

Secondary outcomes

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

    Time frame: 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.

  2. change in Partners in Health Scale (PIHS) scores

    Time frame: 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.

  3. Percentage of completed call or text message

    Time frame: up to 12 weeks

    Feasibility will be reported as a percentage of completed calls or text messages.

  4. Change in FACT-B Scores

    Time frame: 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.

  5. Change in FACT-P Scores

    Time frame: 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.

  6. Change in FACT-C Scores

    Time frame: 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.

  7. Change in FACT-LC Scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Oncology Nursing Society

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 5, 2021
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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