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Culturally Tailored Nurse Coaching Study for Cancer Symptom Management

Primary Purpose

Dehydration, Symptom Cluster, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CTNSM
Standard of Care Chemotherapy Education
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dehydration focused on measuring symptom self-management, symptom severity, emotional support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Miami Sylvester Comprehensive Cancer Ctr.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CTNSM Group

Standard of Care (control) Group

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
Incidents of dehydration
Incidents of unscheduled medical visits for IV hydration

Secondary Outcome Measures

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

Full Information

First Posted
April 30, 2021
Last Updated
May 31, 2023
Sponsor
University of Miami
Collaborators
Oncology Nursing Society
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1. Study Identification

Unique Protocol Identification Number
NCT04874584
Brief Title
Culturally Tailored Nurse Coaching Study for Cancer Symptom Management
Official Title
Utilizing a Culturally Tailored Nurse Coaching Intervention to Decrease Symptom Severity and Prevent Dehydration in Patients With Metastatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 27, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Oncology Nursing Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration, Symptom Cluster, Quality of Life, Self Efficacy, Chemotherapy Effect
Keywords
symptom self-management, symptom severity, emotional support

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CTNSM Group
Arm Type
Experimental
Arm 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.
Arm Title
Standard of Care (control) Group
Arm Type
Active Comparator
Arm Description
Participants in the control group will only be receiving the standard of care chemotherapy education.
Intervention Type
Behavioral
Intervention Name(s)
CTNSM
Intervention Description
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 .
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care Chemotherapy Education
Intervention Description
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 Outcome Measure Information:
Title
Change in MDASI scores
Description
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.
Time Frame
baseline, up to 12 weeks
Title
Incidents of dehydration
Description
Incidents of unscheduled medical visits for IV hydration
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
change in Chronic Disease Self-Efficacy Scale (CDSES) scores
Description
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.
Time Frame
baseline, up to 12 weeks
Title
change in Partners in Health Scale (PIHS) scores
Description
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.
Time Frame
baseline, up to 12 weeks
Title
Percentage of completed call or text message
Description
Feasibility will be reported as a percentage of completed calls or text messages.
Time Frame
up to 12 weeks
Title
Change in FACT-B Scores
Description
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.
Time Frame
baseline, up to 12 weeks
Title
Change in FACT-P Scores
Description
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.
Time Frame
baseline, up to 12 weeks
Title
Change in FACT-C Scores
Description
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.
Time Frame
baseline, up to 12 weeks
Title
Change in FACT-LC Scores
Description
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.
Time Frame
baseline, up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natasha Solle, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Sylvester Comprehensive Cancer Ctr.
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/33600392/
Description
Nurse-Delivered Telephone Intervention to Reduce Oral Mucositis and Prevent Dehydration

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Culturally Tailored Nurse Coaching Study for Cancer Symptom Management

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