Rehabilitation After Breast Cancer (REBECCA II)
2021年8月26日 更新者：Christoffer Johansen、Danish Cancer Society
Individually Tailored Rehabilitation After Breast Cancer
The aim of the study is to evaluate whether a screening-based individually tailored nurse navigator intervention compared to standard care significantly reduce psychological and physical symptoms among women being treated for breast cancer who had moderate-to-severe distress (score ≥ 7 on the distress thermometer).
調査の概要
詳細な説明
During a 2-year period, 758 patients newly diagnosed with breast cancer will be screened for inclusion at the Section of Breast Surgery at Rigshospitalet, Copenhagen.
Of these 324 participants enter the randomized controlled trial (RCT) and are randomized in a computer-generated sequence of 1:1 to the intervention (nurse-navigation) or control group (standard care).
A total of 432 participants will enter an observational questionnaire study.
All participants are followed for 1,5 years.
研究の種類
介入
入学 (実際)
309
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
-
-
-
Copenhagen、デンマーク、DK-2100
- Rigshospitalet
-
-
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
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- Newly diagnosed with breast cancer (i.e. prior to surgery), scheduled for breast cancer surgery at Section of Breast Surgery at Rigshospitalet, 18 years or above, Danish citizen, read, understand and speak Danish, female gender,signed written informed consent. Those who experience high psychological distress (score ≥ 7 on the distress thermometer) will enter the RCT whereas those who experience low psychological distress (score < 7 on the distress thermometer) will be followed in an observational questionnaire study.
Exclusion Criteria:
- no severe cognitive problems or dementia, no severe psychiatric disease requiring treatment, e.g. schizophrenia, alcohol or narcotic dependence,
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 |
|---|---|
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介入なし：コントロール
普段のお手入れ
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実験的：Intervention
Individually tailored nurse navigation
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The intervention consists of systematic report of symptoms to the nurse and up to six individual, manual-based, face-to-face or telephone nurse navigator sessions depending on individual needs.
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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 |
|---|---|---|
|
Distress
時間枠：Change from baseline and to 6,12 months (mixed models)
|
Distress Thermometer
|
Change from baseline and to 6,12 months (mixed models)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Distress
時間枠：Change from baseline to 6 months
|
Distress Thermometer
|
Change from baseline to 6 months
|
|
Distress
時間枠：Change from baseline to 12 months
|
Distress Thermometer
|
Change from baseline to 12 months
|
|
Distress
時間枠：Change from baseline to 18 months
|
Distress Thermometer
|
Change from baseline to 18 months
|
|
Depression
時間枠：Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
The Patient Health Questionnaire (PHQ9)
|
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
|
Depression
時間枠：Change from baseline and to 6 months
|
The Patient Health Questionnaire (PHQ9)
|
Change from baseline and to 6 months
|
|
Depression
時間枠：Change from baseline and to 12 months
|
The Patient Health Questionnaire (PHQ9)
|
Change from baseline and to 12 months
|
|
Depression
時間枠：Change from baseline and to 18 months
|
The Patient Health Questionnaire (PHQ9)
|
Change from baseline and to 18 months
|
|
Anxiety
時間枠：Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
Generalized Anxiety Disorder (GAD7)
|
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
|
Anxiety
時間枠：Change from baseline and to 6 months
|
Generalized Anxiety Disorder (GAD7)
|
Change from baseline and to 6 months
|
|
Anxiety
時間枠：Change from baseline and to 12 months
|
Generalized Anxiety Disorder (GAD7)
|
Change from baseline and to 12 months
|
|
Anxiety
時間枠：Change from baseline and to 18 months
|
Generalized Anxiety Disorder (GAD7)
|
Change from baseline and to 18 months
|
|
Health related quality of life summary index
時間枠：Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
|
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
|
Health related quality of life summary index
時間枠：Change from baseline and to 6 months
|
The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
|
Change from baseline and to 6 months
|
|
Health related quality of life summary index
時間枠：Change from baseline and to 12 months
|
The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
|
Change from baseline and to 12 months
|
|
Health related quality of life summary index
時間枠：Change from baseline and to 18 months
|
The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
|
Change from baseline and to 18 months
|
|
Breast cancer related quality of life summary index
時間枠：Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
|
Breast cancer related quality of life summary index
時間枠：Change from baseline and to 6 months
|
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 6 months
|
|
Breast cancer related quality of life summary index
時間枠：Change from baseline and to 12 months
|
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 12 months
|
|
Breast cancer related quality of life summary index
時間枠：Change from baseline and to 18 months
|
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 18 months
|
|
Functional related quality of life summary index
時間枠：Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
|
Functional related quality of life summary index
時間枠：Change from baseline and to 6 months
|
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 6 months
|
|
Functional related quality of life summary index
時間枠：Change from baseline and to 12 months
|
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 12 months
|
|
Functional related quality of life summary index
時間枠：Change from baseline and to 18 months
|
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 18 months
|
|
Physical health related quality of life
時間枠：Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
|
Physical health related quality of life
時間枠：Change from baseline and to 6 months
|
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 6 months
|
|
Physical health related quality of life
時間枠：Change from baseline and to 12 months
|
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 12 months
|
|
Physical health related quality of life
時間枠：Change from baseline and to 18 months
|
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 18 months
|
|
Social health related quality of life
時間枠：Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
|
Social health related quality of life
時間枠：Change from baseline and to 6 months
|
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 6 months
|
|
Social health related quality of life
時間枠：Change from baseline and to 12 months
|
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 12 months
|
|
Social health related quality of life
時間枠：Change from baseline and to 18 months
|
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 18 months
|
|
Emotional health related quality of life
時間枠：Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
|
Emotional health related quality of life
時間枠：Change from baseline and to 6 months
|
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 6 months
|
|
Emotional health related quality of life
時間枠：Change from baseline and to 12 months
|
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 12 months
|
|
Emotional health related quality of life
時間枠：Change from baseline and to 18 months
|
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
|
Change from baseline and to 18 months
|
|
Self-efficacy
時間枠：Change from baseline and to 6,12,18 months (mixed models)
|
Patient Activation Measure (PAM)
|
Change from baseline and to 6,12,18 months (mixed models)
|
|
Self-efficacy
時間枠：Change from baseline and to 6 months
|
Patient Activation Measure (PAM)
|
Change from baseline and to 6 months
|
|
Self-efficacy
時間枠：Change from baseline and to 12 months
|
Patient Activation Measure (PAM)
|
Change from baseline and to 12 months
|
|
Self-efficacy
時間枠：Change from baseline and to 18 months
|
Patient Activation Measure (PAM)
|
Change from baseline and to 18 months
|
|
Fear of recurrence
時間枠：6 months
|
Concerns About Recurrence Questionnaire (CARQ)
|
6 months
|
|
Fear of recurrence
時間枠：12 months
|
Concerns About Recurrence Questionnaire (CARQ)
|
12 months
|
|
Fear of recurrence
時間枠：18 months
|
Concerns About Recurrence Questionnaire (CARQ)
|
18 months
|
|
Pain in the breast surgery area (side of chest, armpit or arm)
時間枠：Change from baseline and to 6,12,18 months (mixed models)
|
Self-developed scale
|
Change from baseline and to 6,12,18 months (mixed models)
|
|
Pain in the breast surgery area (side of chest, armpit or arm)
時間枠：Change from baseline and to 6 months
|
Self-developed scale
|
Change from baseline and to 6 months
|
|
Pain in the breast surgery area (side of chest, armpit or arm)
時間枠：Change from baseline and to 12 months
|
Self-developed scale
|
Change from baseline and to 12 months
|
|
Pain in the breast surgery area (side of chest, armpit or arm)
時間枠：Change from baseline and to 18 months
|
Self-developed scale
|
Change from baseline and to 18 months
|
|
Neuropathy in the breast surgery area (side of chest, armpit or arm)
時間枠：Change from baseline and to 6,12,18 months (mixed models)
|
Self-developed scale
|
Change from baseline and to 6,12,18 months (mixed models)
|
|
Neuropathy in the breast surgery area (side of chest, armpit or arm)
時間枠：Change from baseline and to 6 months
|
Self-developed scale
|
Change from baseline and to 6 months
|
|
Neuropathy in the breast surgery area (side of chest, armpit or arm)
時間枠：Change from baseline and to 12 months
|
Self-developed scale
|
Change from baseline and to 12 months
|
|
Neuropathy in the breast surgery area (side of chest, armpit or arm)
時間枠：Change from baseline and to 18 months
|
Self-developed scale
|
Change from baseline and to 18 months
|
|
Sleep quality
時間枠：Change from baseline and to 6,12,18 months (mixed models)
|
Pittsburgh Sleep Quality Index (PSQI)
|
Change from baseline and to 6,12,18 months (mixed models)
|
|
Sleep quality
時間枠：Change from baseline and to 6 months
|
Pittsburgh Sleep Quality Index (PSQI)
|
Change from baseline and to 6 months
|
|
Sleep quality
時間枠：Change from baseline and to 12 months
|
Pittsburgh Sleep Quality Index (PSQI)
|
Change from baseline and to 12 months
|
|
Sleep quality
時間枠：Change from baseline and to 18 months
|
Pittsburgh Sleep Quality Index (PSQI)
|
Change from baseline and to 18 months
|
|
Cognitive function - Perceived cognitive impairments
時間枠：Change from baseline and to 6,12,18 months (mixed models)
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
|
Change from baseline and to 6,12,18 months (mixed models)
|
|
Cognitive function - Perceived cognitive impairments
時間枠：Change from baseline and to 6 months
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
|
Change from baseline and to 6 months
|
|
Cognitive function- Perceived cognitive impairments
時間枠：Change from baseline and to 12 months
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
|
Change from baseline and to 12 months
|
|
Cognitive function - Perceived cognitive impairments
時間枠：Change from baseline and to 18 months
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
|
Change from baseline and to 18 months
|
|
Cognitive function - Impact of Perceived cognitive impairments on quality of life
時間枠：Change from baseline and to 6,12,18 months (mixed models)
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
|
Change from baseline and to 6,12,18 months (mixed models)
|
|
Cognitive function - Impact of Perceived cognitive impairments on quality of life
時間枠：Change from baseline and to 6 months
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
|
Change from baseline and to 6 months
|
|
Cognitive function - Impact of Perceived cognitive impairments on quality of life
時間枠：Change from baseline and to 12 months
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
|
Change from baseline and to 12 months
|
|
Cognitive function - Impact of Perceived cognitive impairments on quality of life
時間枠：Change from baseline and to 18 months
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
|
Change from baseline and to 18 months
|
|
Cognitive function - Perceived cognitive abilities
時間枠：Change from baseline and to 6,12,18 months (mixed models)
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
|
Change from baseline and to 6,12,18 months (mixed models)
|
|
Cognitive function - Perceived cognitive abilities
時間枠：Change from baseline and to 6 months
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
|
Change from baseline and to 6 months
|
|
Cognitive function - Perceived cognitive abilities
時間枠：Change from baseline and to 12 months
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
|
Change from baseline and to 12 months
|
|
Cognitive function - Perceived cognitive abilities
時間枠：Change from baseline and to 18 months
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
|
Change from baseline and to 18 months
|
|
Need for support
時間枠：Change from baseline and to 6,12,18 months (mixed models)
|
Single self-developed items
|
Change from baseline and to 6,12,18 months (mixed models)
|
|
Need for support
時間枠：Change from baseline and to 6 months
|
Single self-developed items
|
Change from baseline and to 6 months
|
|
Need for support
時間枠：Change from baseline and to 12 months
|
Single self-developed items
|
Change from baseline and to 12 months
|
|
Need for support
時間枠：Change from baseline and to 18 months
|
Single self-developed items
|
Change from baseline and to 18 months
|
|
Health care costs
時間枠：Cumulative from baseline to 18 months
|
Costs will be obtained through registries on health care services and combined with information on health status using the 5Q-5D from the EuroQol Research Foundation's
|
Cumulative from baseline to 18 months
|
|
Acceptability
時間枠：18 months
|
Single self-developed items
|
18 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Social support
時間枠：Baseline
|
Modified Medical Outcomes Study Social Support Scale (MOS)
|
Baseline
|
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。
スポンサー
捜査官
- 主任研究者：Pernille Bidstrup, PhD、Danish Cancer Society Research Center
- 主任研究者：Christoffer Johansen, DMSc、Rigshispitalet
- スタディチェア：Birgitte Mertz, RN、Rigshospitalet, Denmark
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)
2017年8月15日
一次修了 (実際)
2021年3月31日
研究の完了 (実際)
2021年3月31日
試験登録日
最初に提出
2017年7月31日
QC基準を満たした最初の提出物
2017年8月16日
最初の投稿 (実際)
2017年8月21日
学習記録の更新
投稿された最後の更新 (実際)
2021年8月27日
QC基準を満たした最後の更新が送信されました
2021年8月26日
最終確認日
2021年8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。
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