Culturally Tailored Nurse Coaching Study for Cancer Symptom Management
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CTNSM Group 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
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 .
Behavioral: 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.
|
| Active Comparator: Standard of Care (control) Group Participants in the control group will only be receiving the standard of care chemotherapy education. |
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures
- Change in MDASI scores [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.
- Incidents of dehydration [up to 12 weeks]
Incidents of unscheduled medical visits for IV hydration
Secondary Outcome Measures
- change in Chronic Disease Self-Efficacy Scale (CDSES) scores [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.
- change in Partners in Health Scale (PIHS) scores [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.
- Percentage of completed call or text message [up to 12 weeks]
Feasibility will be reported as a percentage of completed calls or text messages.
- Change in FACT-B Scores [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.
- Change in FACT-P Scores [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.
- Change in FACT-C Scores [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.
- Change in FACT-LC Scores [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Eligible for Chemotherapy for the first time (Previous & Ongoing hormonal only treatment allowed OR Neoadjuvant & Adjuvant chemotherapy regimens with 2+ drugs allowed)
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18 years old
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Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
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There are no life expectancy restrictions
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Women of child-bearing potential are allowed in the study as long as they are eligible for the chemotherapy treatment.
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Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
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Patients on immunotherapy only will be excluded
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Previous chemotherapy
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Under 18 years old
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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.
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No access to a telephone
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Miami Sylvester Comprehensive Cancer Ctr. | Miami | Florida | United States | 33136 |
Sponsors and Collaborators
- University of Miami
- Oncology Nursing Society
Investigators
- Principal Investigator: Natasha Solle, PhD, University of Miami
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20201491