Virtual Intervention for Lung Cancer

NCT01684696 | Withdrawn DMC

• 2 other identifiers: 12-09184(pC ID): 237290
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer is the leading cause of cancer death in both men and women. Lung cancer is unique because of racial disparity, persistent mortality rate, and social stigma. Lung cancer stigma (LCS) and difficult patient-clinician communication may be an underlying factor in health disparities in lung cancer. The purpose of this study is to PILOT test, in a diverse sample of lung cancer patients the effectiveness of the mHealth Tool for Lung Cancer patients (mHealthTLC), an interactive, immersive 3-dimensional iPad application that allows individuals to experience first person virtual visits with their clinicians, to improve patient-clinician communication, decrease LCS, and promote optimal self-management. The study hypotheses are that patients who receive the mHealth TLC will improve their ability to communicate effectively with their clinicians and will report decreased stigma related to their lung cancer diagnosis compared to the attention control group.

Conditions

Lung Neoplasms

Keywords

Lung cancer; stigma; virtual intervention; mHealth

Outcome Measures

Primary Outcomes (2)

• Patient-clinician communication scores

  The Medical Communication Competence Scale (MCCS) measures patients' perceptions of their competence to effectively communicate. The Patients' Self-Competence Subscale of the MCCS has 16-items with a 5 point Likert-type scaling of 5 (important) to 1 (unimportant). Higher scores indicate greater perceived self-competence. The Quality of Physician-Patient Interaction (QQPPI) measures distinct domains that establish a high quality clinician-provider interaction (i.e.,information exchange, patient involvement, and sharing in the decision making process). Fourteen items are summed to yield a total score; higher scores indicate increased quality of communication as perceived by the patient.

  3 months

• Perceived lung cancer stigma

  The Cataldo Lung Cancer Stigma Scale (CLCSS) will be used to assess stigma. The CLCSS is a 31 item measure with each item rated on a 4-point Likert-type scale (strongly disagree to strongly agree). Higher values indicate higher levels of LCS.The CLCSS was found to be a reliable and valid measure with a diverse sample of people with lung cancer. Construct validity was supported by expected relationships with related constructs: self-esteem, depression, social support, and social conflict. The total scale Cronbach alpha coefficient was 0.96, the Cronbach alphas for the four subscales were: stigma/shame, 0.96; social isolation, 0.95; discrimination, 0.92; and smoking 0.76.

  3 months

Secondary Outcomes (3)

• Lung Cancer symptoms

  3 months

• Depression

  3 months

• Quality of Life (QOL)

  3 months

Study Arms (2)

mHealth TLC

EXPERIMENTAL

The mhealth TLC group will meet with a nurse before each of 4 clinician visits and use the mHealth TLC on an iPad with an interactive 3-dimensional intervention that allows individuals to experience virtual visits with their clinicians. Key aspects of mHealthTLC include informational videos about lung cancer and LCS. Blame and self-blame will be addressed, information about the role of addiction, social/cultural factors, and tobacco industry influence on smoking behaviors will be highlighted. Patients will experience practiced interaction in ever increasing complex situations with avatars (i.e., receptionist, medical assistant, and clinician). A "virtual coach" will accompany the patient through the virtual visit and will provide information and coaching (as needed).

Behavioral: Virtual experience

Attention Control

ACTIVE COMPARATOR

Attention control group (ACG) - Patients assigned to the ACG will meet with a nurse and receive only the informational videos on an iPad before 4 clinician visits with assessments after each clinician visit. An effort will be made to match the intervention condition on salience, credibility, and contact time.

Behavioral: Videos

Interventions

Virtual experience BEHAVIORAL

mHealth TLC

Videos BEHAVIORAL

Attention Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Unable to understand or tolerate the battery of questionnaires due to physical or mental health issues (i.e., dementia, active psychosis).

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Social Stigma

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Janine Cataldo, PhD

  UCSF Department of Physiological Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 13, 2012
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

US (1)