Malignant NeoplasmNCT02197091
Communication Effectiveness in Cancer Treatment
An observational study of Malignant Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This pilot research trial studies communication effectiveness in cancer treatment. Studying how well patients and their doctors communicate about the treatment being given for cancer may help improve the decisions that patients and physicians make together. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- questionnaire administration and medical chart review
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Mar 2016
- Phase
- Observational
- 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
Study population: Adults receiving cancer treatment
Who may be able to join
- Patients with a diagnosis of cancer
- Patients must have been in active therapy for cancer for at least one month or have a scheduled surgical treatment of their cancer
- Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: A Health Services Research Study to Evaluate Communication Effectiveness in Oncology Treatment
This pilot research trial studies communication effectiveness in cancer treatment. Studying how well patients and their doctors communicate about the treatment being given for cancer may help improve the decisions that patients and physicians make together.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility of measuring discrepancies between patient and physician perceptions about the intent of therapy.
SECONDARY OBJECTIVES:
- To explore possible correlation between various patient satisfaction indicators and discrepant patient perceptions about their care.
II. To gather exploratory data on patient characteristics that might correlate with discrepant patient perceptions about their care.
OUTLINE:
Patients complete questionnaires, including the Functional Assessment of Cancer Therapy-Treatment Satisfaction (FACIT-TS-G), the Functional Assessment of Cancer Therapy-Spiritual Well Being (FACIT-Sp12), the Medical Outcomes Study Social Support Survey (MOS-SSS), and the Distress Thermometer (DT). Doctors also complete a questionnaire. Patients' medical records may be reviewed, if necessary.
After completion of study, patients are followed up for 5 years.
- Conditions
- Malignant Neoplasm
- Being tested
- questionnaire administration, medical chart review
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
Ancillary studies
medical chart reviewOther
Also called chart review
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Observational (communication in oncology treatment) | Patients complete questionnaires, including the FACIT-TS-G, the FACIT-Sp12, the MOS-SSS, and the DT. Doctors also complete a questionnaire. Patients' medical records may be reviewed, if necessary. Receives: Other: questionnaire administration; Other: medical chart review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient perceptions about the nature of their therapy and diagnosis
The precision of agreement between patient's and doctor's responses about the intent of therapy will be assessed. The level of agreement between the questions as answered by the patient on the Prognosis Instrument and by the doctor on the Doctor Questionnaire will be assessed. Agreement will be measured as either "yes" (meaning the doctor and patient responses match exactly) or "no" (any other combination, if both doctor and patient responded). The primary measure of agreement will be the Kappa statistic; the Kappa and its corresponding 95% confidence interval (CI) will be reported.
Measured: Baseline
Feasibility, as assessed by accrual rate
Accrual will be estimated as the number of patients accrued divided by the months of accrual. A 95% confidence interval for the monthly accrual will be calculated based on the Poisson distribution.
Measured: Up to 5 years
Feasibility, as assessed by participation rate
The participation rate will be estimated as the number of patients who are participants divided by the number eligible. This estimate will be calculated separately by cancer type to see what cancer types are more or less likely to participate. An exact 95% CI will be calculated for this estimate of each cancer type.
Measured: Up to 5 years
Secondary outcomes (1)
Incidence of discrepancies between patient perceptions and the clinical record
The FACIT-TS-G, FACIT-Sp12, MOS-SSS, and DT instruments will be used to see if there might be a relationship between the observed scores and discrepancies in the answers provided by patients and the clinical record. Patient characteristics will be assessed for differences between the two records. Means, standard deviations, and medians will be calculated for each of the scores, stratified by discrepancy type for those who do not match and those who match perfectly. These data will be analyzed by analysis of variance.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2016
- Study completionMar 2016
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.
- More trials run by Wake Forest University Health SciencesThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Katharine Duckworth, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197091
- Sponsor's protocol ID
- IRB00028889
- Other IDs
- NCI-2014-01478, IRB00028889, CCCWFU #99514, P30CA012197
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2014
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Health Services Research Study to Evaluate Communication Effectiveness in Oncology Treatment
- ClinicalTrials.gov ID
- NCT02197091
- Acronym / sponsor ID
- IRB00028889
- Conditions
- Malignant Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2014 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Jul 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 research trial studies communication effectiveness in cancer treatment. Studying how well patients and their doctors communicate about the treatment being given for cancer may help improve the decisions that patients and physicians make together.
Detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility of measuring discrepancies between patient and physician perceptions about the intent of therapy.
SECONDARY OBJECTIVES:
- To explore possible correlation between various patient satisfaction indicators and discrepant patient perceptions about their care.
II. To gather exploratory data on patient characteristics that might correlate with discrepant patient perceptions about their care.
OUTLINE:
Patients complete questionnaires, including the Functional Assessment of Cancer Therapy-Treatment Satisfaction (FACIT-TS-G), the Functional Assessment of Cancer Therapy-Spiritual Well Being (FACIT-Sp12), the Medical Outcomes Study Social Support Survey (MOS-SSS), and the Distress Thermometer (DT). Doctors also complete a questionnaire. Patients' medical records may be reviewed, if necessary.
After completion of study, patients are followed up for 5 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (communication in oncology treatment) | – | Other: questionnaire administration, Other: medical chart reviewPatients complete questionnaires, including the FACIT-TS-G, the FACIT-Sp12, the MOS-SSS, and the DT. Doctors also complete a questionnaire. Patients' medical records may be reviewed, if necessary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults receiving cancer treatment
Key inclusion criteria (3 listed)
- Patients with a diagnosis of cancer
- Patients must have been in active therapy for cancer for at least one month or have a scheduled surgical treatment of their cancer
- Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| questionnaire administrationAncillary studies | Other | Observational (communication in oncology treatment) |
| medical chart reviewAlso: chart reviewAncillary studies | Other | Observational (communication in oncology treatment) |
Primary outcome
Patient perceptions about the nature of their therapy and diagnosis
Time frame: Baseline
The precision of agreement between patient's and doctor's responses about the intent of therapy will be assessed. The level of agreement between the questions as answered by the patient on the Prognosis Instrument and by the doctor on the Doctor Questionnaire will be assessed. Agreement will be measured as either "yes" (meaning the doctor and patient responses match exactly) or "no" (any other combination, if both doctor and patient responded). The primary measure of agreement will be the Kappa statistic; the Kappa and its corresponding 95% confidence interval (CI) will be reported.
Feasibility, as assessed by accrual rate
Time frame: Up to 5 years
Accrual will be estimated as the number of patients accrued divided by the months of accrual. A 95% confidence interval for the monthly accrual will be calculated based on the Poisson distribution.
Feasibility, as assessed by participation rate
Time frame: Up to 5 years
The participation rate will be estimated as the number of patients who are participants divided by the number eligible. This estimate will be calculated separately by cancer type to see what cancer types are more or less likely to participate. An exact 95% CI will be calculated for this estimate of each cancer type.
1 secondary outcome
Incidence of discrepancies between patient perceptions and the clinical record
Time frame: Baseline
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 3 Jul 2018.
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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.
Katharine Duckworth, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasm, run by Wake Forest University Health Sciences 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 0 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 3 Jul 2018. 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?
Patient perceptions about the nature of their therapy and diagnosis (time frame: Baseline). The study lists 3 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 3 Jul 2018.