Malignant NeoplasmNCT04266522
Medical Physics Direct Patient Care for the Improvement of Patient Understanding of Care
A study testing Informational Intervention, Counseling and Questionnaire Administration in people with Malignant Neoplasm, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
This phase II trial studies how well medical physics direct patient care works in improving patients' understanding of their cancer treatment. Providing direct physicist-patient interactions and answering patients' questions about their cancer treatment may help patients to understand the care and therefore reduce… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Informational Intervention, Counseling and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2020to 30 Sep 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medical physicists will be eligible if they care for patients within the Gershenson Radiation Oncology Center within the Karmanos Cancer Institute and have completed the patient communication training
- Are able to read and write in English
- Are scheduled for curative radiation therapy at the Gershenson Radiation Oncology Center
Who cannot join
- NONE
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
Official title: Medical Physics Direct Patient Care Initiative - Communication Intervention Study Protocol
This phase II trial studies how well medical physics direct patient care works in improving patients' understanding of their cancer treatment. Providing direct physicist-patient interactions and answering patients' questions about their cancer treatment may help patients to understand the care and therefore reduce anxiety and distress during treatment.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate whether the Medical Physics Direct Patient Care Initiative (MPDPCI) improves anxiety/distress.
SECONDARY OBJECTIVE:
II. To assess whether the MPDPCI improves patient treatment adherence and overall satisfaction.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive printed materials describing the technical aspects of their treatment.
ARM II: Patients receive printed materials as in Arm I. Patients also receive a minimum of 2 direct physicist interactions to describe the technical aspects of their treatment either immediately prior to or immediately after treatment simulation.
- Conditions
- Malignant Neoplasm
- Being tested
- Informational Intervention, Counseling, Questionnaire Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational InterventionOther
Receive printed materials
CounselingOther
Also called counseling, Counseling Intervention
Receive direct physicist interactions to describe the technical aspects of the treatment
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (printed materials) | Active comparator | Patients receive printed materials describing the technical aspects of their treatment. Receives: Other: Informational Intervention; Other: Questionnaire Administration |
| Arm II (printed materials, physicist interaction) | Experimental | Patients receive printed materials as in Arm I. Patients also receive a minimum of 2 direct physicist interactions to describe the technical aspects of their treatment either immediately prior to or immediately after treatment simulation. Receives: Other: Informational Intervention; Other: Counseling; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Will be assessed using linear mixed-effects models. These objectives will be evaluated based on the difference between groups across three time points (i.e., group-effect) using the baseline corrected measurements. Each patient will be considered as random-effects along with the repeated measurements at three time points. The repeated measurements at three time points will be handled by autocorrelated residuals within groups.
Measured: 4 months
Distress
Will be assessed using linear mixed-effects models. These objectives will be evaluated based on the difference between groups across three time points (i.e., group-effect) using the baseline corrected measurements. Each patient will be considered as random-effects along with the repeated measurements at three time points. The repeated measurements at three time points will be handled by autocorrelated residuals within groups.
Measured: 4 months
Secondary outcomes (1)
Patient treatment adherence
Will be assessed using 2-sided unpaired t-test.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start16 Jan 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jay Burmeister, Barbara Ann Karmanos Cancer Institute
- Investigators
- Jay Burmeister, PhD, Principal investigator, Barbara Ann Karmanos Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266522
- Sponsor's protocol ID
- 2019-104
- Other IDs
- P30CA022453
- Status last verified
- Oct 2022
- First submitted
- 10 Feb 2020
- Last updated
- 7 Oct 2022
- 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 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Physics Direct Patient Care Initiative - Communication Intervention Study Protocol
- ClinicalTrials.gov ID
- NCT04266522
- Acronym / sponsor ID
- 2019-104
- Conditions
- Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 12 Feb 2020 (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.
This phase II trial studies how well medical physics direct patient care works in improving patients' understanding of their cancer treatment. Providing direct physicist-patient interactions and answering patients' questions about their cancer treatment may help patients to understand the care and therefore reduce anxiety and distress during treatment.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate whether the Medical Physics Direct Patient Care Initiative (MPDPCI) improves anxiety/distress.
SECONDARY OBJECTIVE:
II. To assess whether the MPDPCI improves patient treatment adherence and overall satisfaction.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive printed materials describing the technical aspects of their treatment.
ARM II: Patients receive printed materials as in Arm I. Patients also receive a minimum of 2 direct physicist interactions to describe the technical aspects of their treatment either immediately prior to or immediately after treatment simulation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (printed materials) | Active comparator | Other: Informational Intervention, Other: Questionnaire AdministrationPatients receive printed materials describing the technical aspects of their treatment. |
| Arm II (printed materials, physicist interaction) | Experimental | Other: Informational Intervention, Other: Counseling, Other: Questionnaire AdministrationPatients receive printed materials as in Arm I. Patients also receive a minimum of 2 direct physicist interactions to describe the technical aspects of their treatment either immediately prior to or immediately after treatment simulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medical physicists will be eligible if they care for patients within the Gershenson Radiation Oncology Center within the Karmanos Cancer Institute and have completed the patient communication training
- Are able to read and write in English
- Are scheduled for curative radiation therapy at the Gershenson Radiation Oncology Center
Key exclusion criteria (1 listed)
- NONE
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 |
|---|---|---|
| Informational InterventionReceive printed materials | Other | Arm I (printed materials), Arm II (printed materials, physicist interaction) |
| CounselingAlso: counseling, Counseling InterventionReceive direct physicist interactions to describe the technical aspects of the treatment | Other | Arm II (printed materials, physicist interaction) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (printed materials), Arm II (printed materials, physicist interaction) |
Primary outcome
Anxiety
Time frame: 4 months
Will be assessed using linear mixed-effects models. These objectives will be evaluated based on the difference between groups across three time points (i.e., group-effect) using the baseline corrected measurements. Each patient will be considered as random-effects along with the repeated measurements at three time points. The repeated measurements at three time points will be handled by autocorrelated residuals within groups.
Distress
Time frame: 4 months
Will be assessed using linear mixed-effects models. These objectives will be evaluated based on the difference between groups across three time points (i.e., group-effect) using the baseline corrected measurements. Each patient will be considered as random-effects along with the repeated measurements at three time points. The repeated measurements at three time points will be handled by autocorrelated residuals within groups.
1 secondary outcome
Patient treatment adherence
Time frame: 4 months
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 7 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Jay Burmeister, PhD principal investigator
Barbara Ann Karmanos Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informational Intervention, Counseling and Questionnaire Administration in people with Malignant Neoplasm, run by Barbara Ann Karmanos Cancer Institute 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 3 inclusion and 1 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 7 Oct 2022. 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?
Anxiety (time frame: 4 months). 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 7 Oct 2022.