Healthy, no Evidence of DiseaseNCT02129517
Web-Based Tailored Educational Program in Improving Nurse Communication With Patients About Clinical Trials
A study testing IMPACT intervention, Online education materials and survey administration in people with Healthy, no Evidence of Disease, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This pilot, randomized clinical trial studies a web-based tailored educational program in improving nurse communication with patients about clinical trial treatment options. A web-based tailored educational program may empower and prepare nurses to discuss clinical trial treatment options with patients and may also… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy, no Evidence of Disease
- What is being tested?
- IMPACT intervention, Online education materials and survey administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,262 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2014to 1 Oct 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Currently practicing nurse
- Involved in direct patient care
- Self-identify in one of the following primary practice roles--case managers, clinical nurse specialists, nurse practitioners, managers/coordinators, nurse navigators, patient educators, and staff nurses
- Available email address
Who cannot join
- Research nurses, nurses without direct patient care, and nurse managers/directors (i.e. not involved in direct patient care)
- Lack of email address
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Oncology Nurse IMPACT: Improving Communication With Patients About Clinical Trials
This pilot, randomized clinical trial studies a web-based tailored educational program in improving nurse communication with patients about clinical trial treatment options. A web-based tailored educational program may empower and prepare nurses to discuss clinical trial treatment options with patients and may also increase patient participation in clinical trials.
Read the detailed description
PRIMARY OBJECTIVES:
- To develop and pilot test a theory-driven, web-based, tailored, interactive educational program (Oncology Nurse IMPACT: Improving Communication with Patients about Clinical Trials) for oncology nurses to address barriers to discussing clinical trials with patients.
II. To implement Oncology Nurse IMPACT on a national level and conduct a formal program evaluation.
III. To evaluate the mediators and moderators of education program effect on intentions to discuss clinical trials with patients.
OUTLINE: Participants are assigned to 1 of 2 intervention arms.
ARM I: Oncology nurses watch web-based informational video clips addressing knowledge, attitudes, subjective norms, and perceived behavioral control (barriers of discussing clinical trials with patients). They also watch role-play video clips to help improve perceived behavioral control and address attitudinal barriers.
ARM II: Oncology nurses view online clinical trials educational materials developed based upon National Cancer Institute (NCI) clinical trials educational materials for health care providers. The educational materials contain text and tables as presented on the NCI Website.
After completion of study intervention, participants are followed for 3 months.
- Conditions
- Healthy, no Evidence of Disease
- Being tested
- IMPACT intervention, Online education materials, survey administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPACT interventionOther
Also called intervention, educational, educational intervention
Tailored, web-based educational short video clips
Online education materialsOther
Also called intervention, educational
Online NCI-based educational materials
survey administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (IMPACT Intervention) | Experimental | Oncology nurses watch tailored, web-based informational video clips addressing knowledge, attitudes, subjective norms, and perceived behavioral control (barriers of discussing clinical trials with patients). They also watch role-play video clips to help improve perceived behavioral control and address attitudinal barriers. Receives: Other: IMPACT intervention; Other: survey administration |
| Arm II (online educational materials) | Active comparator | Oncology nurses view online clinical trials educational materials developed based upon NCI clinical trials educational materials for health care providers. The educational materials contain text and tables as presented on the NCI Website. Receives: Other: Online education materials; Other: survey administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nurse's intention to discuss clinical trials with patients
Behavioral intention will be assessed using 4 items (3 with 7 point scales, strongly agree/strongly disagree and 1 which asks for an estimated number of patients). An analysis of covariance (ANCOVA) will be used to compare intention scores, adjusting for the pre-intervention intention score as well as age, ethnicity, education, access to clinical trials, and years spent in nursing as well as other key factors found to be significantly imbalanced between groups.
Measured: Baseline to 3 months post-intervention
Secondary outcomes (1)
Change in knowledge, attitudes, normative beliefs, and perceived behavioral control
Actual behavior will be measured using a 3-item scale asking participants to provide an estimate of how many patients they spoke with about cancer clinical trials in the past three months (3-month follow-up) and over the past week (subset of nurses completing the biweekly ecological momentary assessment surveys). An ANCOVA approach will be used to examine effects of the intervention on knowledge, attitudes, behavioral control and normative beliefs.
Measured: Baseline to 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study start7 Nov 2014
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy, no Evidence of DiseaseStudies of the same condition, open and under way.
- 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
- 1,262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Neal Meropol, MD, Principal investigator, Case Comprehensive Cancer CenterBarbara Daly, PhD, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129517
- Sponsor's protocol ID
- CASE2Z14
- Other IDs
- NCI-2014-00829, CASE2Z14
- Status last verified
- Jul 2020
- First submitted
- 30 Apr 2014
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Flocke SA, Nock NL, Fulton S, Margevicius S, Manne S, Meropol NJ, Daly BJ. A National Study of Oncology Nurses Discussing Cancer Clinical Trials With Patients. West J Nurs Res. 2019 Dec;41(12):1747-1760. doi: 10.1177/0193945919829145. Epub 2019 Feb 19.
PubMed 30782111
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncology Nurse IMPACT: Improving Communication With Patients About Clinical Trials
- ClinicalTrials.gov ID
- NCT02129517
- Acronym / sponsor ID
- CASE2Z14
- Conditions
- Healthy, no Evidence of Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,262 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Nov 2014 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 2 May 2014 (estimated)
- 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.
This pilot, randomized clinical trial studies a web-based tailored educational program in improving nurse communication with patients about clinical trial treatment options. A web-based tailored educational program may empower and prepare nurses to discuss clinical trial treatment options with patients and may also increase patient participation in clinical trials.
Detailed description
PRIMARY OBJECTIVES:
- To develop and pilot test a theory-driven, web-based, tailored, interactive educational program (Oncology Nurse IMPACT: Improving Communication with Patients about Clinical Trials) for oncology nurses to address barriers to discussing clinical trials with patients.
II. To implement Oncology Nurse IMPACT on a national level and conduct a formal program evaluation.
III. To evaluate the mediators and moderators of education program effect on intentions to discuss clinical trials with patients.
OUTLINE: Participants are assigned to 1 of 2 intervention arms.
ARM I: Oncology nurses watch web-based informational video clips addressing knowledge, attitudes, subjective norms, and perceived behavioral control (barriers of discussing clinical trials with patients). They also watch role-play video clips to help improve perceived behavioral control and address attitudinal barriers.
ARM II: Oncology nurses view online clinical trials educational materials developed based upon National Cancer Institute (NCI) clinical trials educational materials for health care providers. The educational materials contain text and tables as presented on the NCI Website.
After completion of study intervention, participants are followed for 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (IMPACT Intervention) | Experimental | Other: IMPACT intervention, Other: survey administrationOncology nurses watch tailored, web-based informational video clips addressing knowledge, attitudes, subjective norms, and perceived behavioral control (barriers of discussing clinical trials with patients). They also watch role-play video clips to help improve perceived behavioral control and address attitudinal barriers. |
| Arm II (online educational materials) | Active comparator | Other: Online education materials, Other: survey administrationOncology nurses view online clinical trials educational materials developed based upon NCI clinical trials educational materials for health care providers. The educational materials contain text and tables as presented on the NCI Website. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Currently practicing nurse
- Involved in direct patient care
- Self-identify in one of the following primary practice roles--case managers, clinical nurse specialists, nurse practitioners, managers/coordinators, nurse navigators, patient educators, and staff nurses
- Available email address
Key exclusion criteria (2 listed)
- Research nurses, nurses without direct patient care, and nurse managers/directors (i.e. not involved in direct patient care)
- Lack of email address
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 |
|---|---|---|
| IMPACT interventionAlso: intervention, educational, educational interventionTailored, web-based educational short video clips | Other | Arm I (IMPACT Intervention) |
| Online education materialsAlso: intervention, educationalOnline NCI-based educational materials | Other | Arm II (online educational materials) |
| survey administrationAncillary studies | Other | Arm I (IMPACT Intervention), Arm II (online educational materials) |
Primary outcome
Change in nurse's intention to discuss clinical trials with patients
Time frame: Baseline to 3 months post-intervention
Behavioral intention will be assessed using 4 items (3 with 7 point scales, strongly agree/strongly disagree and 1 which asks for an estimated number of patients). An analysis of covariance (ANCOVA) will be used to compare intention scores, adjusting for the pre-intervention intention score as well as age, ethnicity, education, access to clinical trials, and years spent in nursing as well as other key factors found to be significantly imbalanced between groups.
1 secondary outcome
Change in knowledge, attitudes, normative beliefs, and perceived behavioral control
Time frame: Baseline to 3 months post-intervention
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 21 Jul 2020.
- Derived from this study: PubMed 30782111Flocke SA, Nock NL, Fulton S, Margevicius S, Manne S, Meropol NJ, Daly BJ. A National Study of Oncology Nurses Discussing Cancer Clinical Trials With Patients. West J Nurs Res. 2019 Dec;41(12):1747-1760. doi: 10.1177/0193945919829145. Epub 2019 Feb 19.
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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.
Neal Meropol, MD principal investigator
Case Comprehensive Cancer Center
Barbara Daly, PhD principal investigator
Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPACT intervention, Online education materials and survey administration in people with Healthy, no Evidence of Disease, run by Case Comprehensive Cancer Center 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 4 inclusion and 2 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 21 Jul 2020. 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 nurse's intention to discuss clinical trials with patients (time frame: Baseline to 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02129517, which also lists 1 linked publication.
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 21 Jul 2020.