Culturally Tailored Nurse Coaching Study for Cancer Symptom Management

Study Overview
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Brief Summary
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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.

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

Conditions
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Dehydration, Symptom Cluster, Quality of Life, Self Efficacy, Chemotherapy Effect

Intervention / Treatment
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* Behavioral: CTNSM
* Behavioral: Standard of Care Chemotherapy Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTNSM Group<br>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<br>* 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 .<br>Behavioral: Standard of Care Chemotherapy Education<br>* 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.<br>|
| Active Comparator: Standard of Care (control) Group<br>Participants in the control group will only be receiving the standard of care chemotherapy education. | Behavioral: Standard of Care Chemotherapy Education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Percentage of completed call or text message | Feasibility will be reported as a percentage of completed calls or text messages. | up to 12 weeks | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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symptom self-management, symptom severity, emotional support