Communication Training in Promoting Employment Retention Among Cancer Patients

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

Using Communication Training to Promote Employment Retention Among Cancer Survivors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02895490
• Other study ID #: MCC-14021
• Secondary ID: NCI-2013-02478HM
• Status: Terminated
• Phase: N/A
• First received: September 6, 2016
• Last updated: September 19, 2016
• Start date: January 2014
• Est. completion date: October 2015

Study information

• Verified date: September 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: October 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Other:
• educational intervention
Receive a DVD containing educational information and communication skills
• communication skills training
Receive a DVD containing educational information and communication skills
• educational intervention
Receive information about the LINC group
• questionnaire administration
Ancillary studies
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Compare the amount of weekly hours worked between treatment and control arms.	Compare weekly hours of work between the treatment and control arms	Baseline to up to 52 weeks	No
Secondary	Compare the amount of employed vs non-employed subjects between treatment and control arms.	Compare employment status (employed vs non-employed) between the treatment and control arms.	Baseline to up to 52 weeks	No