NCT02895490

Brief Summary

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

1.1 years

First QC Date

September 6, 2016

Last Update Submit

September 19, 2016

Conditions

Outcome Measures

Primary Outcomes (3)

  • Changes in perceived self-efficacy pre-intervention and post-intervention.

    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.

    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.

    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 Outcomes (2)

  • Compare the amount of weekly hours worked between treatment and control arms.

    Baseline to up to 52 weeks

  • Compare the amount of employed vs non-employed subjects between treatment and control arms.

    Baseline to up to 52 weeks

Study Arms (2)

Arm I (DVD)

EXPERIMENTAL

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: educational interventionOther: communication skills trainingOther: questionnaire administrationOther: quality-of-life assessment

Arm II (control)

ACTIVE COMPARATOR

Patients receive information about the LINC group.

Other: educational interventionOther: questionnaire administrationOther: quality-of-life assessment

Interventions

Receive a DVD containing educational information and communication skills

Also known as: intervention, educational
Arm I (DVD)

Receive a DVD containing educational information and communication skills

Arm I (DVD)

Ancillary studies

Arm I (DVD)Arm II (control)

Ancillary studies

Also known as: quality of life assessment
Arm I (DVD)Arm II (control)

Eligibility Criteria

Age21 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with prior cancer except non-melanoma skin cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Interventions

Early Intervention, EducationalMethods

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesInvestigative Techniques

Study Officials

  • Richard Brown

    Massey Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 9, 2016

Study Start

January 1, 2014

Primary Completion

February 1, 2015

Study Completion

October 1, 2015

Last Updated

September 20, 2016

Record last verified: 2016-09

Locations