Rehabilitation After Breast Cancer (REBECCA II)
2021년 8월 26일 업데이트: 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).
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
309
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Copenhagen, 덴마크, DK-2100
- Rigshospitalet
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
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,
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: 제어
평소 케어
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Distress
기간: Change from baseline and to 6,12 months (mixed models)
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Distress Thermometer
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Change from baseline and to 6,12 months (mixed models)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Distress
기간: Change from baseline to 6 months
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Distress Thermometer
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Change from baseline to 6 months
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Distress
기간: Change from baseline to 12 months
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Distress Thermometer
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Change from baseline to 12 months
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Distress
기간: Change from baseline to 18 months
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Distress Thermometer
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Change from baseline to 18 months
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Depression
기간: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
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The Patient Health Questionnaire (PHQ9)
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Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
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Depression
기간: Change from baseline and to 6 months
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The Patient Health Questionnaire (PHQ9)
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Change from baseline and to 6 months
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Depression
기간: Change from baseline and to 12 months
|
The Patient Health Questionnaire (PHQ9)
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Change from baseline and to 12 months
|
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Depression
기간: Change from baseline and to 18 months
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The Patient Health Questionnaire (PHQ9)
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Change from baseline and to 18 months
|
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Anxiety
기간: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
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Generalized Anxiety Disorder (GAD7)
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Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
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Anxiety
기간: Change from baseline and to 6 months
|
Generalized Anxiety Disorder (GAD7)
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Change from baseline and to 6 months
|
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Anxiety
기간: Change from baseline and to 12 months
|
Generalized Anxiety Disorder (GAD7)
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Change from baseline and to 12 months
|
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Anxiety
기간: Change from baseline and to 18 months
|
Generalized Anxiety Disorder (GAD7)
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Change from baseline and to 18 months
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Health related quality of life summary index
기간: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
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The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
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Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
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Health related quality of life summary index
기간: Change from baseline and to 6 months
|
The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
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Change from baseline and to 6 months
|
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Health related quality of life summary index
기간: 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
기간: Change from baseline and to 18 months
|
The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
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Change from baseline and to 18 months
|
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Breast cancer related quality of life summary index
기간: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
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BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
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Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
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Breast cancer related quality of life summary index
기간: Change from baseline and to 6 months
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BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
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Change from baseline and to 6 months
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Breast cancer related quality of life summary index
기간: Change from baseline and to 12 months
|
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
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Change from baseline and to 12 months
|
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Breast cancer related quality of life summary index
기간: Change from baseline and to 18 months
|
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
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Change from baseline and to 18 months
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Functional related quality of life summary index
기간: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
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Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
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Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
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Functional related quality of life summary index
기간: Change from baseline and to 6 months
|
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
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Change from baseline and to 6 months
|
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Functional related quality of life summary index
기간: Change from baseline and to 12 months
|
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
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Change from baseline and to 12 months
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Functional related quality of life summary index
기간: Change from baseline and to 18 months
|
Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
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Change from baseline and to 18 months
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Physical health related quality of life
기간: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
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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)
|
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Physical health related quality of life
기간: 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
기간: 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
기간: Change from baseline and to 18 months
|
Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
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Change from baseline and to 18 months
|
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Social health related quality of life
기간: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
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Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
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Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
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Social health related quality of life
기간: Change from baseline and to 6 months
|
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
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Change from baseline and to 6 months
|
|
Social health related quality of life
기간: Change from baseline and to 12 months
|
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
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Change from baseline and to 12 months
|
|
Social health related quality of life
기간: Change from baseline and to 18 months
|
Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
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Change from baseline and to 18 months
|
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Emotional health related quality of life
기간: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
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Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
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Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
|
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Emotional health related quality of life
기간: Change from baseline and to 6 months
|
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
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Change from baseline and to 6 months
|
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Emotional health related quality of life
기간: 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
기간: Change from baseline and to 18 months
|
Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
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Change from baseline and to 18 months
|
|
Self-efficacy
기간: Change from baseline and to 6,12,18 months (mixed models)
|
Patient Activation Measure (PAM)
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Change from baseline and to 6,12,18 months (mixed models)
|
|
Self-efficacy
기간: Change from baseline and to 6 months
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Patient Activation Measure (PAM)
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Change from baseline and to 6 months
|
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Self-efficacy
기간: Change from baseline and to 12 months
|
Patient Activation Measure (PAM)
|
Change from baseline and to 12 months
|
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Self-efficacy
기간: Change from baseline and to 18 months
|
Patient Activation Measure (PAM)
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Change from baseline and to 18 months
|
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Fear of recurrence
기간: 6 months
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Concerns About Recurrence Questionnaire (CARQ)
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6 months
|
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Fear of recurrence
기간: 12 months
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Concerns About Recurrence Questionnaire (CARQ)
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12 months
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Fear of recurrence
기간: 18 months
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Concerns About Recurrence Questionnaire (CARQ)
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18 months
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Pain in the breast surgery area (side of chest, armpit or arm)
기간: Change from baseline and to 6,12,18 months (mixed models)
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Self-developed scale
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Change from baseline and to 6,12,18 months (mixed models)
|
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Pain in the breast surgery area (side of chest, armpit or arm)
기간: Change from baseline and to 6 months
|
Self-developed scale
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Change from baseline and to 6 months
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Pain in the breast surgery area (side of chest, armpit or arm)
기간: 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)
기간: Change from baseline and to 18 months
|
Self-developed scale
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Change from baseline and to 18 months
|
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Neuropathy in the breast surgery area (side of chest, armpit or arm)
기간: Change from baseline and to 6,12,18 months (mixed models)
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Self-developed scale
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Change from baseline and to 6,12,18 months (mixed models)
|
|
Neuropathy in the breast surgery area (side of chest, armpit or arm)
기간: Change from baseline and to 6 months
|
Self-developed scale
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Change from baseline and to 6 months
|
|
Neuropathy in the breast surgery area (side of chest, armpit or arm)
기간: 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)
기간: Change from baseline and to 18 months
|
Self-developed scale
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Change from baseline and to 18 months
|
|
Sleep quality
기간: 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)
|
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Sleep quality
기간: Change from baseline and to 6 months
|
Pittsburgh Sleep Quality Index (PSQI)
|
Change from baseline and to 6 months
|
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Sleep quality
기간: Change from baseline and to 12 months
|
Pittsburgh Sleep Quality Index (PSQI)
|
Change from baseline and to 12 months
|
|
Sleep quality
기간: Change from baseline and to 18 months
|
Pittsburgh Sleep Quality Index (PSQI)
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Change from baseline and to 18 months
|
|
Cognitive function - Perceived cognitive impairments
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
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Cognitive function - Impact of Perceived cognitive impairments on quality of life
기간: 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
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Cognitive function - Perceived cognitive abilities
기간: 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)
|
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Cognitive function - Perceived cognitive abilities
기간: 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
기간: 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
기간: Change from baseline and to 18 months
|
Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
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Change from baseline and to 18 months
|
|
Need for support
기간: 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)
|
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Need for support
기간: Change from baseline and to 6 months
|
Single self-developed items
|
Change from baseline and to 6 months
|
|
Need for support
기간: Change from baseline and to 12 months
|
Single self-developed items
|
Change from baseline and to 12 months
|
|
Need for support
기간: Change from baseline and to 18 months
|
Single self-developed items
|
Change from baseline and to 18 months
|
|
Health care costs
기간: 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
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Cumulative from baseline to 18 months
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Acceptability
기간: 18 months
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Single self-developed items
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18 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Social support
기간: Baseline
|
Modified Medical Outcomes Study Social Support Scale (MOS)
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Baseline
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Pernille Bidstrup, PhD, Danish Cancer Society Research Center
- 수석 연구원: Christoffer Johansen, DMSc, Rigshispitalet
- 연구 의자: Birgitte Mertz, RN, Rigshospitalet, Denmark
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 8월 15일
기본 완료 (실제)
2021년 3월 31일
연구 완료 (실제)
2021년 3월 31일
연구 등록 날짜
최초 제출
2017년 7월 31일
QC 기준을 충족하는 최초 제출
2017년 8월 16일
처음 게시됨 (실제)
2017년 8월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 8월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 8월 26일
마지막으로 확인됨
2021년 8월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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