A Problem-Solving Intervention for Family Caregivers in Palliative Oncology
2021年10月24日 更新者:Karla Washington、University of Missouri-Columbia
In congruence with the National Cancer Institute's commitment to supporting families of individuals with cancer across the full disease trajectory, the investigators seek to examine the feasibility of a technologically-mediated problem-solving intervention designed to improve the quality of life and decrease the psychological distress of family caregivers of cancer patients receiving outpatient palliative care.
Investigators involved in this mixed methods pilot study will collect and analyze both quantitative and qualitative data, which will subsequently inform a large-scale randomized clinical trial of the problem-solving intervention.
調査の概要
詳細な説明
Palliative oncology providers are ideally situated to improve the cancer journey for the millions of family members and friends who are vital to the care of seriously ill patients.
In recent decades, the primary setting for cancer care has shifted from the hospital inpatient unit to the outpatient clinic, leaving family caregivers responsible for providing the majority of patient care in the home, often with little support or preparation.
The numerous stressors associated with family caregiving often give rise to caregiver anxiety, depression, fatigue, neglect of self-care and, for particularly strained caregivers, psychological symptoms that mirror those experienced by trauma survivors.
In congruence with the National Cancer Institute's commitment to supporting families of individuals with cancer across the full disease trajectory, the investigators seek to examine the feasibility of a technologically-mediated problem-solving intervention designed to improve the quality of life and decrease the psychological distress of family caregivers of cancer patients receiving outpatient palliative care.
Specifically, the investigators aim to 1) examine the feasibility of the intervention relative to recruitment, randomization, retention, and fidelity to core intervention components; 2) investigate the impact of the intervention on family caregiver anxiety, depression, and quality of life; and 3) explore the benefits and challenges associated with the intervention from the perspective of participants.
To accomplish these aims, investigators will recruit and randomly assign 82 family caregivers of cancer patients receiving outpatient palliative care into two groups (usual care and intervention) and collect quantitative and qualitative data, which will be analyzed to inform a future large-scale randomized clinical trial of the problem-solving intervention.
研究の種類
介入
入学 (実際)
83
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
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Missouri
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Columbia、Missouri、アメリカ、65212
- University of Missouri Ambulatory Palliative Care Clinic
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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
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- 18 years of age or older,
- access to an Internet-connected device that will support videoconferencing software
Exclusion Criteria:
- Younger than 18 years of age,
- lack of access to an Internet-connected device that will support videoconferencing software
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: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 |
|---|---|
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アクティブコンパレータ:Unenhanced Monitoring
Family caregivers of cancer patients receiving outpatient palliative care will complete standardized questionnaires at the time of study enrollment and two, four, and eight weeks after study enrollment.
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Study participant completes standardized questionnaires upon study enrollment and at two, four, and eight weeks after study enrollment.
他の名前:
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実験的:Problem-Solving Intervention
Family caregivers of cancer patients receiving outpatient palliative care will use videoconferencing tools to participate in three problem-solving sessions with a member of the research team.
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Study participant completes standardized questionnaires upon study enrollment and at two, four, and eight weeks after study enrollment.
他の名前:
The problem-solving approach that will be taught in the problem-solving intervention is based on the ADAPT model, which encourages participants to follow five steps when solving problems: focus on adopting a positive attitude to problem-solving, define the problem and set goals, generate a list of alternative solutions to the problem, predict consequences of the alternative solutions, and try implementing the most promising solution from among the list of alternatives.
The problem-solving intervention will be delivered by a trained interventionist in three structured sessions using videoconferencing tools.
他の名前:
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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 |
|---|---|---|
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Change in anxiety (as measured by the Generalized Anxiety Disorder Form - 7)
時間枠:Upon study enrollment, two weeks, four weeks, eight weeks
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Family caregivers indicate the frequency with which they experience seven different symptoms of anxiety (7 items); higher scores reflect higher anxiety severity.
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Upon study enrollment, two weeks, four weeks, eight weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in depression (as measured by the Patient Health Questionnaire - 9)
時間枠:Upon study enrollment, two weeks, four weeks, eight weeks
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Family caregivers indicate the frequency with which they experience nine different symptoms of depression (9 items); higher scores reflect higher depression severity.
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Upon study enrollment, two weeks, four weeks, eight weeks
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Change in problem-solving approach (as measured by the Problem-Solving Inventory)
時間枠:Upon study enrollment, two weeks, four weeks, eight weeks
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Family caregivers indicate the extent to which different statements describing approaches to problem-solving apply to them (25 items).
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Upon study enrollment, two weeks, four weeks, eight weeks
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Change in quality of life (as measured by the Caregiver Quality of Life Index - Revised)
時間枠:Upon study enrollment, two weeks, four weeks, eight weeks
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Family caregivers complete four items rating their physical, emotional, social, and financial quality of life on a scale of 0-10.
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Upon study enrollment, two weeks, four weeks, eight weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in caregiving problems and intensity
時間枠:Upon study enrollment, two weeks, four weeks, eight weeks
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Family caregivers select three problems and rate their corresponding distress using a scale of 0-3 where 0 = problem is not at all distressful and 3 = problem is very distressful (3 items).
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Upon study enrollment, two weeks, four weeks, eight weeks
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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:Karla Washington, PhD、University of Missouri-Columbia
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Washington KT, Benson JJ, Chakurian DE, Popejoy LL, Demiris G, Rolbiecki AJ, Oliver DP. Comfort Needs of Cancer Family Caregivers in Outpatient Palliative Care. J Hosp Palliat Nurs. 2021 Jun 1;23(3):221-228. doi: 10.1097/NJH.0000000000000744.
- Washington KT, Craig KW, Parker Oliver D, Ruggeri JS, Brunk SR, Goldstein AK, Demiris G. Family caregivers' perspectives on communication with cancer care providers. J Psychosoc Oncol. 2019 Nov-Dec;37(6):777-790. doi: 10.1080/07347332.2019.1624674. Epub 2019 Jun 16.
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 (実際)
2015年4月1日
一次修了 (実際)
2017年4月29日
研究の完了 (実際)
2017年5月24日
試験登録日
最初に提出
2015年4月17日
QC基準を満たした最初の提出物
2015年4月27日
最初の投稿 (見積もり)
2015年4月28日
学習記録の更新
投稿された最後の更新 (実際)
2021年10月26日
QC基準を満たした最後の更新が送信されました
2021年10月24日
最終確認日
2021年10月1日
詳しくは
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。
緩和ケアの臨床試験
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Washington University School of MedicineColumbia University; Indiana University; Rakai Health Sciences Program; Reach the Youth Uganda完了コントロールアーム_Bolstered Care | 治療アーム_HIVRR+S+FL | 治療ARM_HIVRR+S+FL+Mウガンダ
Unenhanced Monitoringの臨床試験
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Karolinska Institutet完了
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Philips Clinical & Medical Affairs Global募集
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Royal Brompton & Harefield NHS Foundation TrustUniversity of Oxford; National Institute for Health Research, United Kingdom完了
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Marmara University募集
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University of AarhusOdense University Hospital; Aarhus University Hospital; Protac A/S; Innovation Fund Denmark募集