Communication Training in Promoting Employment Retention Among Cancer Patients

September 19, 2016 updated by: Virginia Commonwealth University

Using Communication Training to Promote Employment Retention Among Cancer Survivors

This randomized clinical trial studies communication training in promoting employment retention among cancer patients. Communication training may improve patient-employer communication and increase the likelihood that cancer patients will remain employed, reduce patients' time away from work, and increase workplace accommodations that enable patients to balance treatment and work.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRIMARY OBJECTIVES:

I. Demonstrate the efficacy of the DVD intervention to a) increase patients' knowledge of their legal rights in the workplace, b) improve patient perceptions of workplace communication about the impact of cancer treatment and ongoing surveillance, and c) increase the number of requested and received workplace accommodations.

II. Compare employment status (employed vs non-employed) between the treatment and control arms.

III. Compare weekly hours of work between the treatment and control arms.

OUTLINE: Patients are randomized to 1 of 2 arms.

Arm I: Patients receive a DVD containing educational information about patients' legal rights in the workplace and communication skills demonstrated through four scenarios depicting a variety of employer-employee communication challenges for patients, provided by the Legal Information Network for Cancer (LINC) group.

Arm II: Patients receive information about the LINC group

After completion of study, patients are followed up at 4, 12, and 52 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University/Massey Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a new, primary diagnosis of a solid tumor
  • Employed full- or part-time at the time of enrollment
  • English-speaking
  • Able to participate in telephone interviews
  • Able to view a 1-hour DVD
  • Patients must have a treatment plan that includes chemotherapy and be within 2 weeks of initiating chemotherapy

Exclusion Criteria:

  • Patients with prior cancer except non-melanoma skin cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm I (DVD)
Patients receive a DVD containing educational information about patients' legal rights in the workplace and communication skills demonstrated through four scenarios depicting a variety of employer-employee communication challenges for patients, provided by LINC group.
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
Other: educational intervention
Receive a DVD containing educational information and communication skills
Other Names:
  • intervention, educational
Other: communication skills training
Receive a DVD containing educational information and communication skills
Other: educational intervention
Receive information about the LINC group
Other Names:
  • intervention, educational
Active Comparator: Arm II (control)
Patients receive information about the LINC group.
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
Other: educational intervention
Receive a DVD containing educational information and communication skills
Other Names:
  • intervention, educational
Other: educational intervention
Receive information about the LINC group
Other Names:
  • intervention, educational

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in perceived self-efficacy pre-intervention and post-intervention.
Time Frame: Baseline to up to 52 weeks
Modify the Perceived Efficacy in Patient-Physician Interactions (PEPPI) to measure patient confidence in talking with their employer. The revised version will focus on patients' level of confidence in discussing employer accommodation and seeking support from their employer. The PEPPI is a brief ten-item measure that asks patients to rate on a Likert scale their confidence in communicating. It is a widely used measure with strong psychometric properties anchored at 5 - "very confident" and 1 - "not at all confident." Thus, the investigators plan to evaluate communication self-efficacy before and after patients in the experimental group view the DVD to explore changes in perceived self-efficacy as a result of communication training. The investigators will compare this change with changes in the control group patients' perceived self-efficacy by matching the timing of the pre-post administration of the measure in both groups.
Baseline to up to 52 weeks
Compare requested pre-intervention measures to received post-intervention measures.
Time Frame: Baseline to up to 52 weeks
During the baseline (pre-intervention) interview patients will answer these questions about specific workplace topics the patients is interested in discussing with their employer, such as available accommodations. During the interviews, each patient will complete a matched questionnaire asking about whether or not they discussed these topics. A score of "1" on the pre-intervention measure indicates patients wanted to discuss the item and the same score on the post-interventions measures indicates that this topic was discussed. A score of "0" in the post-intervention measure indicates that this expectation was not met.
Baseline to up to 52 weeks
Compare longitudinal changes in knowledge scale before and after combination information and communication skills training.
Time Frame: Baseline to up to 52 weeks
To aid knowledge acquisition, the investigators have linked didactic teaching with video recorded scenarios exemplifying use of knowledge and skills to achieve increased knowledge. The investigators have developed a knowledge measure and in collaboration with Dr. Dumenci will rigorously test the scale. The investigators will then use this scale to determine whether patients' knowledge improves as a result of the combination of information and communication skills training proposed in this intervention. Therefore, knowledge will be measured before the intervention and after the intervention. The investigators will then compare the experimental and control groups' longitudinal changes in knowledge.
Baseline to up to 52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compare the amount of weekly hours worked between treatment and control arms.
Time Frame: Baseline to up to 52 weeks
Compare weekly hours of work between the treatment and control arms
Baseline to up to 52 weeks
Compare the amount of employed vs non-employed subjects between treatment and control arms.
Time Frame: Baseline to up to 52 weeks
Compare employment status (employed vs non-employed) between the treatment and control arms.
Baseline to up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard Brown, Massey Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MCC-14021 (Other Identifier: Virginia Commonwealth University/Massey Cancer Center)
  • NCI-2013-02478 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • HM14021 (Other Identifier: IRB No.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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