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Virtual Intervention for Lung Cancer (VILC)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01684696
First received: September 5, 2012
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Lung Neoplasms
Behavioral: Virtual experience
Behavioral: Videos

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Virtual Intervention for Lung Cancer

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Patient-clinician communication scores [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Perceived lung cancer stigma [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Lung Cancer symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Lung Cancer Symptoms - Lung Cancer Symptom Scale (LCSS) measures the physical and functional dimensions of persons with lung cancer. The scale has 9 items: six measuring major symptoms for lung cancer (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and three summary items related to total symptoms. The item scale is 0 (best) and 100 (worst). An average of all 9 items is the total score.

  • Depression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Depression - Center for Epidemiologic Studies-Depression (CES-D) is a 20-item scale that is widely used for self-ratings of depression in clinical populations, including people with cancer.

  • Quality of Life (QOL) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    QOL - The QOL Inventory is a 33-item instrument that measures four dimensions of QOL in cancer patients (i.e., symptoms, social concerns, psychological well-being, and physical well being).


Estimated Enrollment: 50
Study Start Date: June 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mHealth TLC
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
Active Comparator: Attention Control
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

Detailed Description:

This is a two arm experimental design PILOT test of the mHealth Tool for Lung Cancer patients (mHealthTLC) an intervention to improve patient-clinician communication, decrease lung cancer stigma, and decrease lung cancer symptom scores. Patients will be assigned to either the mHealth TLC group or the Attention Control Group (ACG). Interventions in both groups will be delivered online or by iPad in a research office in the clinician's building prior to each visit. Assessments will be done immediately after each visit in the same research room. Intervention and assessment pre-visit is expected to take less than one hour, the intervention is expected to take 30mins, and post assessment is expected to take 30 minutes. A follow-up assessment will be done at 3 months from enrollment.

mhealth TLC group will meet with a nurse just before each of 4 clinician visits and use the mHealth TLC on an iPad with an interactive, immersive 3-dimensional (3-D) intervention that allows individuals to experience virtual visits with their clinicians. The mHealth TLC provides engagement and experiential learning by delivering important information about symptom management and provides the opportunity to practice a new communication strategy in ever increasing complex situations with a virtual coach, receptionist, assistant, and clinician.During the mHealthTLC the patient will enter a virtual clinic office, travel through the different aspects of a typical clinic visit, and interact with office staff and clinicians that are represented by avatars. The avatars will be designed to reflect ethnic and cultural diversity. First person is the preferred format for health teaching because the patient is active as self and not represented as an avatar. The first person vantage point facilitates the immersion and immediacy of the experience. Key aspects of mHealthTLC include informational videos about lung cancer (i.e. etiology, diagnosis, treatment, symptoms) 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. Information and training will be provided and patients will be able to 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). The advantages to adding a virtual coach or avatar include the availability of an always-live agent and the capability of customizing the coach to represent an ideal social model for a particular user or group of users.Flexibility exists in how to design not only how the coach will appear but also how the coach will sound - with an appropriate voice and engaging non-verbal communication). This approach contributes to cultural and ethnic sensitivity. As the patient attempts to communicate and receive information appropriate for a self-management plan, they will receive "points" for successful communication. A cumulative score and explanation will be given at the end of the virtual visit. During the visit the participant will identify specific topics and questions that they want to address during their visit with their real clinician; they will receive a printout of their priority questions that they can take into the visit with their real clinician. The research nurse will review the score, the priority questions, and the overall virtual experience. Virtual environments for learning are sufficiently promising that further investment and development of this type of research is warranted.

Attention control group (ACG)- Patients assigned to the ACG will meet with a nurse and receive the informational videos from the mHealth TLC 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria are >21 years old with a diagnosis of lung cancer (any type or stage), able to read and write English at 5th grade level, able to sign an IRB approved consent form, and expects to have 4 visits with the same clinician in the next 2 months.

Exclusion Criteria:

  • Unable to understand or tolerate the battery of questionnaires due to physical or mental health issues (i.e., dementia, active psychosis).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684696

Contacts
Contact: Janine Cataldo, PhD 415 476 4721 Janine.Cataldo@nursing.ucsf.edu

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center Not yet recruiting
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Janine Cataldo, PhD UCSF Department of Physiological Nursing
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01684696     History of Changes
Other Study ID Numbers: 12-09184, (pC ID): 237290
Study First Received: September 5, 2012
Last Updated: June 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Lung cancer
stigma
virtual intervention
mHealth

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014