肺患者の介護者が利用可能な支持療法リソースについて学ぶのを支援する Web ベースのプログラム (CONNECT)
肺がん介護者を対象とした CONNECT 介入のための複数施設の地域腫瘍学計画
Clinical trial that tests the feasibility of a web based caregiver support resource, along with caregiver navigation sessions for caregivers of patients with stage II-IV lung cancer. The Caregiver Oncology Needs Evaluation Tool (CONNECT) is a novel web-based intervention designed for the community oncology setting, to systematically connect lung cancer caregivers with tailored supportive care resources. Lung cancer caregivers provide critical and challenging care for their loved ones and are at risk for their own negative psychosocial and physical outcomes. Implementing the CONNECT program along with caregiver navigation may provide additional support to caregivers of patients with stage II-IV lung cancer.
調査の概要
状態
詳細な説明
This study is a multi-site randomized pilot trial enrolling 120 lung cancer caregiver-patient dyads (i.e., lung cancer caregivers (n=120) and their care-recipients (n=120)) across approximately 8-12 practices to assess the multi-site feasibility of a caregiver technology-based intervention (CONNECT) to identify caregivers' needs and connect them with supportive care resources. Caregivers will be randomized 1:1:1 to either the CONNECT intervention, usual care comparison group or generic resource list comparison group. CONNECT is a web-based intervention that empowers and educates caregivers about the benefits of supportive care services and systematically identifies unmet needs to connect lung cancer caregivers with tailored supportive care resources. The Central Caregiver Navigator will assist caregivers with resolving barriers to accessing resources and work with the Local Practice Referral Coordinator to process referrals. Caregivers and patients will complete measures at baseline (prior to caregiver randomization), and 12 and 24 weeks after baseline. Feasibility measures (retention, accrual rates, and participation) will be evaluated to inform the future trial. The Local Practice Referral Coordinator for each practice will report on time needed for practice participation, referral processes, and communication processes with the Central Caregiver Navigator.
Participants (i.e., patients or care-recipients) will be asked to complete study surveys at three time points:
- After consenting and before randomization of participant and caregiver. (Initial survey)
- Approximately 12 weeks after completing the first survey (12-week survey)
- Approximately 24 weeks after completing the first survey (24-week survey)
Each survey will take about 30-45 minutes to complete. The forms will ask about things such as demographics (sex, race, etc.), cancer symptoms, satisfaction with cancer care and health behaviors. You don't have to answer any question that makes you feel uncomfortable. These surveys can be done remotely over the internet, in the clinic, by phone or by mail.
Caregivers will also complete surveys at three time points and will be assigned to 1 of 3 study groups:
- Group 1 will be given the usual care provided at your clinic. At the completion of the study, this group will be given the generic supportive care resource list for their use that Group 2 received.
- Group 2 will be provided with a generic supportive care resource list.
- Group 3 will be asked to watch a brief video and complete the web-based CONNECT program either in the clinic or on your own device. The CONNECT program is designed to help identify any unmet needs and connect the caregiver with tailored supportive care resources, based on specific needs. The CONNECT Navigator will follow-up with within 2 business days of completion of the program and again 4 weeks later.
Caregiver Participants (Group 1, 2 and 3) will be asked to complete study surveys at three time points:
- After consenting and before randomization of participant and caregiver. (Initial survey)
- Approximately 12 weeks after completing the first survey (12-week survey)
- Approximately 24 weeks after completing the first survey (24-week survey)
Each survey will take about 35-45 minutes to complete. The forms will ask about things such as demographics (sex, race, etc.), caregiving experience, use of supportive care resources, quality of life, mood, and social needs (housing, transportation, utilities, etc). You don't have to answer any question that makes you feel uncomfortable.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Colorado
-
Denver、Colorado、アメリカ、80205
- Kaiser Permanente-Franklin
-
Lafayette、Colorado、アメリカ、80026
- Kaiser Permanente - Rock Creek
-
Lone Tree、Colorado、アメリカ、80124
- Kaiser Permanente - Lone Tree
-
-
Delaware
-
Millville、Delaware、アメリカ、19967
- Beebe South Coastal Health Campus
-
Rehoboth Beach、Delaware、アメリカ、19971
- Beebe Health Campus
-
-
Georgia
-
Augusta、Georgia、アメリカ、30912
- Augusta University Medical Center
-
-
Hawaii
-
Honolulu、Hawaii、アメリカ、96813
- Hawaii Cancer Care Inc - Waterfront Plaza
-
‘Aiea、Hawaii、アメリカ、96701
- Hawaii Cancer Care - Westridge
-
-
Missouri
-
Osage Beach、Missouri、アメリカ、65065
- Lake Regional Hospital
-
Springfield、Missouri、アメリカ、65807
- CoxHealth South Hospital
-
-
New York
-
The Bronx、New York、アメリカ、10461
- Montefiore Medical Center-Einstein Campus
-
-
North Carolina
-
Winston-Salem、North Carolina、アメリカ、27157
- Wake Forest NCORP Research Base
-
-
Pennsylvania
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Scranton、Pennsylvania、アメリカ、18510
- Community Medical Center
-
Wilkes-Barre、Pennsylvania、アメリカ、18711
- Geisinger Wyoming Valley/Henry Cancer Center
-
-
South Carolina
-
Gaffney、South Carolina、アメリカ、29341
- Gibbs Cancer Center-Gaffney
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Greenville、South Carolina、アメリカ、29615
- Prisma Health Cancer Institute - Eastside
-
Greenville、South Carolina、アメリカ、29605
- Prisma Health Cancer Institute - Butternut
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Greer、South Carolina、アメリカ、29651
- Gibbs Cancer Center-Pelham
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Spartanburg、South Carolina、アメリカ、29303
- Spartanburg Medical Center
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Union、South Carolina、アメリカ、29379
- MGC Hematology Oncology-Union
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Wisconsin
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Appleton、Wisconsin、アメリカ、54911
- ThedaCare Regional Cancer Center
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Green Bay、Wisconsin、アメリカ、54311
- Aurora BayCare Medical Center
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Kenosha、Wisconsin、アメリカ、53142
- Aurora Cancer Care-Kenosha South
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Milwaukee、Wisconsin、アメリカ、53215
- Aurora Saint Luke's Medical Center
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Neenah、Wisconsin、アメリカ、54956
- ThedaCare Regional Medical Center - Neenah
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Patient Inclusion Criteria:
- Must be ≥ 18 years of age, as this study is focused on the experience of adult patient-caregiver dyads
- Must have a current diagnosis of new (i.e., initial diagnosis) or recurrent stage II-IV lung cancer
- Must be enrolled after the start of anticancer systemic therapy (+/- radiation therapy) with at least 9 weeks of any planned anticancer treatment remaining
- Must be ambulatory and up (i.e., not bedridden) more than 50% of waking hours
- Must self-report receiving informal (i.e., not professional) care from a caregiver who meets the study caregiver criteria and who is willing to participate
Caregiver Inclusion Criteria:
- Must be ≥18 years of age, as this study is focused on the experience of adult patient-caregiver dyads
- Must self-report providing informal (i.e. not professional) care during cancer treatment for a patient who meets the patient criteria and who is willing to participate
- Must have access to the internet at home or be willing to use CONNECT in the clinic
- Must have access to telephone to complete sessions with the central caregiver navigator
Patient Exclusion Criteria:
- Patients who have completed treatment for their lung cancer at the time of study enrollment
- Enrolled in hospice care
- Unable to read and English and not willing to have someone read surveys for them
Caregiver Exclusion Criteria:
- Self-report currently receiving cancer treatment
- Unable to read and communicate in English, as the CONNECT intervention is currently only available in English
研究計画
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Group 1 (Standard care followed by generic resource list)
Caregivers receive standard care and are then given a generic resource list at week 24. |
Receive a generic resource list |
|
アクティブコンパレータ：Group 2 (Generic resource list)
Caregiver receive a generic resource list at the start of the study. |
Receive a generic resource list |
|
実験的：Group 3 (CONNECT, personalized list, and navigation)
Caregivers receive access to the CONNECT tool, watch an educational video on self care and receive a personalized list of resources based on caregiver preferences. Caregivers also receive access to and complete at least 2 calls, at baseline and at week 4, with a caregiver navigator to review the resource list and address any additional needs. |
Receive personalized resource list Receive access to CONNECT tool Complete calls with caregiver navigator
他の名前：
|
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 |
|---|---|---|
|
Caregiver retention at 12 weeks
時間枠：At 12 weeks
|
Calculated as the following: Number of caregivers who complete at least 75% of the 12-week assessments divided by the number randomized. Retention will be estimated and reported along with an exact 95% confidence interval. |
At 12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Caregiver accrual rate
時間枠：Upon completion of recruitment, approximately 12 months
|
Number of caregivers who agree to participate divided by the number of months of recruitment |
Upon completion of recruitment, approximately 12 months
|
|
Caregiver participation
時間枠：Upon completion of recruitment, approximately 12 months
|
Proportion of eligible caregivers who agreed to participate |
Upon completion of recruitment, approximately 12 months
|
|
Caregiver retention at 24 weeks
時間枠：At 24 weeks
|
Number of caregivers who complete at least 75% of the 24-week assessments divided by the number randomized. |
At 24 weeks
|
|
Caregiver acceptability
時間枠：At 12 weeks
|
Self-report survey developed for this study to assess the degree to which caregivers found different aspects of CONNECT, the generic resource list, or usual care helpful using a Likert response from 0 (Not at all) to 5 (Very Much) |
At 12 weeks
|
|
Average time (minutes) needed for training for Local Practice Referral Coordinator
時間枠：At completion of training, up to 6 months
|
Will be summarized across practices using mean, median, standard deviation and interquartile range. |
At completion of training, up to 6 months
|
|
Desired modality for training (e.g., live webinar, recorded video, paper materials) for Local Practice Referral Coordinator
時間枠：At completion of training, up to 6 months
|
Will be summarized using appropriate descriptive statistics. |
At completion of training, up to 6 months
|
|
Average time (minutes) needed to identify and enter local resources into the Caregiver Oncology Needs Evaluation Tool (CONNECT) database
時間枠：At conclusion of practice intervention activities, an average of 18 months
|
Will be summarized across practices using mean, median, standard deviation and interquartile range. |
At conclusion of practice intervention activities, an average of 18 months
|
|
Frequency of needed resource updates in the CONNECT database
時間枠：Up to completion of practice intervention activities, an average of 18 months
|
Will be summarized across practices using mean, median, standard deviation and interquartile range |
Up to completion of practice intervention activities, an average of 18 months
|
|
Average time (minutes) spent by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm
時間枠：Up to completion of practice intervention activities, an average of 18 months
|
Will be summarized across practices using mean, median, standard deviation and interquartile range. |
Up to completion of practice intervention activities, an average of 18 months
|
|
Modality of contact (e.g. phone, virtual web meeting, email) made by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm
時間枠：Up to completion of practice intervention activities, an average of 18 months
|
Will be summarized using appropriate descriptive statistics. |
Up to completion of practice intervention activities, an average of 18 months
|
|
Number of contacts made by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm
時間枠：Up to completion of practice intervention activities, an average of 18 months
|
Will be summarized across practices using mean, median, standard deviation and interquartile range. |
Up to completion of practice intervention activities, an average of 18 months
|
|
Number of referrals facilitated by the Local Practice Referral Coordinator and Central Caregiver Navigator
時間枠：Up to completion of practice intervention activities, an average of 18 months
|
Will be summarized across practices using mean, median, standard deviation and interquartile range. |
Up to completion of practice intervention activities, an average of 18 months
|
|
Type of referrals (e.g., in person, online) facilitated by the Local Practice Referral Coordinator and Central Caregiver Navigator
時間枠：Up to completion of practice intervention activities, an average of 18 months
|
Will be summarized using appropriate descriptive statistics. |
Up to completion of practice intervention activities, an average of 18 months
|
|
Average time (minutes) needed to communicate for Central Caregiver Navigator and Local Practice Referral Coordinator
時間枠：Up to completion of practice intervention activities, an average of 18 months
|
Will be summarized across practices using mean, median, standard deviation and interquartile range. |
Up to completion of practice intervention activities, an average of 18 months
|
|
Modalities used for communication (e.g., phone, virtual web meeting, email) for Central Caregiver Navigator and Local Practice Referral Coordinator
時間枠：Up to completion of practice intervention activities, an average of 18 months
|
Will be summarized using appropriate descriptive statistics. |
Up to completion of practice intervention activities, an average of 18 months
|
|
Improvements for the future trial from Local Practice Referral Coordinator's perspectives from a survey at the end of the study
時間枠：At completion of practice intervention activities, an average of 18 months
|
Will be summarized using appropriate descriptive statistics. |
At completion of practice intervention activities, an average of 18 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient accrual rate
時間枠：Upon completion of recruitment, approximately 12 months
|
Number of patients who agree to participate divided by the number of months of recruitment |
Upon completion of recruitment, approximately 12 months
|
|
Patient participation rate
時間枠：Upon completion of recruitment, approximately 12 months
|
Proportion of eligible patients who agreed to participate |
Upon completion of recruitment, approximately 12 months
|
|
Patient retention at 12 weeks
時間枠：At 12 weeks
|
Number of patients who complete at least 75% of the 12-week assessments divided by the number randomized |
At 12 weeks
|
|
Patient retention at 24 weeks
時間枠：At 24 weeks
|
Number of patients who complete at least 75% of the 24-week assessments divided by the number randomized |
At 24 weeks
|
協力者と研究者
捜査官
- スタディチェア：Kathryn Weaver, PhD、Wake Forest University Health Sciences
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB00112187
- NCI-2023-10870 (その他の識別子：NCI Trial Identifier)
- Lead Organization Identifier (その他の識別子：WF-2301CD)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
IPD 共有時間枠
6 months after publication for a 2 year duration
IPD 共有アクセス基準
upon request to NCORP@wakehealth.edu
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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