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Virtual Intervention for Lung Cancer (VILC)

2018年10月9日 更新者:University of California, San Francisco
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.

調査の概要

状態

引きこもった

条件

詳細な説明

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.

研究の種類

介入

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • California
      • San Francisco、California、アメリカ、94115
        • UCSF Helen Diller Family Comprehensive Cancer Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

21年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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).
アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Patient-clinician communication scores
時間枠:3 months
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
時間枠:3 months
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

二次結果の測定

結果測定
メジャーの説明
時間枠
Lung Cancer symptoms
時間枠:3 months
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.
3 months
Depression
時間枠:3 months
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.
3 months
Quality of Life (QOL)
時間枠:3 months
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).
3 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Janine Cataldo, PhD、UCSF Department of Physiological Nursing

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2016年8月1日

一次修了 (予想される)

2017年8月1日

研究の完了 (予想される)

2017年9月1日

試験登録日

最初に提出

2012年9月5日

QC基準を満たした最初の提出物

2012年9月10日

最初の投稿 (見積もり)

2012年9月13日

学習記録の更新

投稿された最後の更新 (実際)

2018年10月11日

QC基準を満たした最後の更新が送信されました

2018年10月9日

最終確認日

2018年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 12-09184
  • (pC ID): 237290 (その他の助成金/資金番号:TRDRP 21XT-0063)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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