DehydrationNCT04874584
Culturally Tailored Nurse Coaching Study for Cancer Symptom Management
A study testing CTNSM in people with Dehydration and Symptom Cluster, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dehydration, Symptom Cluster, Quality of Life
- What is being tested?
- CTNSM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2021to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Sylvester Comprehensive Cancer Ctr.
Miami, Florida, 33136
About this study
Official title: Utilizing a Culturally Tailored Nurse Coaching Intervention to Decrease Symptom Severity and Prevent Dehydration in Patients With Metastatic Cancer
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.
- Being tested
- CTNSM, Standard of Care Chemotherapy Education
- Keywords
- symptom self-management, symptom severity, emotional support
- Medical subject headings
- Dehydration, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTNSMBehavioural
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 EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CTNSM Group | Experimental | 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. Receives: Behavioral: CTNSM; Behavioral: Standard of Care Chemotherapy Education |
| Standard of Care (control) Group | Active comparator | Participants in the control group will only be receiving the standard of care chemotherapy education. Receives: Behavioral: Standard of Care Chemotherapy Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, up to 12 weeks
Incidents of dehydration
Incidents of unscheduled medical visits for IV hydration
Measured: up to 12 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start27 Oct 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Oncology Nursing Society
- Responsible party
- Principal investigator, Natasha Solle, PhD, RN, University of Miami
- Investigators
- Natasha Solle, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874584
- Sponsor's protocol ID
- 20201491
- Status last verified
- May 2023
- First submitted
- 30 Apr 2021
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing a Culturally Tailored Nurse Coaching Intervention to Decrease Symptom Severity and Prevent Dehydration in Patients With Metastatic Cancer
- ClinicalTrials.gov ID
- NCT04874584
- Acronym / sponsor ID
- 20201491
- Keywords
- symptom self-management, symptom severity, emotional support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Oncology Nursing Society
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTNSM Group | Experimental | Behavioral: CTNSM, Behavioral: Standard of Care Chemotherapy EducationCulturally 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. |
| Standard of Care (control) Group | Active comparator | Behavioral: Standard of Care Chemotherapy EducationParticipants in the control group will only be receiving the standard of care chemotherapy education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTNSMThe 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 . | Behavioural | CTNSM Group |
| Standard of Care Chemotherapy EducationStandard 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. | Behavioural | CTNSM Group, Standard of Care (control) Group |
Primary outcome
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.
Incidents of dehydration
Time frame: up to 12 weeks
Incidents of unscheduled medical visits for IV hydration
7 secondary outcomes
change in Chronic Disease Self-Efficacy Scale (CDSES) scores
Time frame: baseline, up to 12 weeks
change in Partners in Health Scale (PIHS) scores
Time frame: baseline, up to 12 weeks
Percentage of completed call or text message
Time frame: up to 12 weeks
Change in FACT-B Scores
Time frame: baseline, up to 12 weeks
Change in FACT-P Scores
Time frame: baseline, up to 12 weeks
Change in FACT-C Scores
Time frame: baseline, up to 12 weeks
Change in FACT-LC Scores
Time frame: baseline, up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Nurse-Delivered Telephone Intervention to Reduce Oral Mucositis and Prevent DehydrationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Hypernatremia Fluid Therapy in Childhood Diarrhoea
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Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
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Hydration & Female Life Stages
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natasha Solle, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTNSM in people with Dehydration and Symptom Cluster, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MDASI scores (time frame: baseline, up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.