- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02306252
The CARE Program: CAncer REhabilitation Pilot Study for Older Adults (CARE Program)
2017년 9월 11일 업데이트: UNC Lineberger Comprehensive Cancer Center
LCCC 1409: The CARE Program: CAncer REhabilitation Pilot Study for Older Adults
The CARE Program is a randomized trial of a cancer rehabilitation program designed to help older cancer patients who have shown to have a loss of function.
연구 개요
상세 설명
This is a prospective, two-arm, single-center randomized controlled pilot trial of a cancer rehabilitation program for older adults, titled the 'CARE program,' which is designed to maintain and/or improve functional status and quality of life in older adults diagnosed with cancer.
Adults aged 65 years and older with cancer will be screened with a Geriatric Assessment (GA) for eligibility.
Although breast cancer patients will be eligible, this study will focus primarily on other types of cancers.
Adults with at least one functional deficit --defined as impairment in ability to perform activities of daily living or instrumental activities of daily living, cognitive decline or balance -- will be randomized to either the intervention (CARE program) or to the control arm (Supportive care services information only).
Both arms will receive a brochure about the supportive care program to provide patients who we've identified as having deficits with information about auxiliary services available and because the intent is to limit the difference between the groups.
We hypothesize that patients who participate in the CARE program will maintain or improve functional status and quality of life when compared to supportive care services information only.
연구 유형
중재적
등록 (실제)
67
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
North Carolina
-
Chapel Hill, North Carolina, 미국, 27599
- University of North Carolina
-
-
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
65년 이상 (고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
Inclusion Criteria:
- Aged 65 years or older
- Has an outpatient appointment within UNC Chapel Hill Lineberger Comprehensive Cancer Center
- Diagnosis of cancer within last two years.
- Has a life expectancy of 12 months or longer. All cancer types are included.
- English speaking
- Willing to complete the UNC GA
- Has at least one functional deficit as defined by GA screen
- Understands study design, risks, and benefits and have signed informed consent
- Willing to be randomized into either study arm
- Ability to safely participate in outpatient rehabilitation program
Exclusion Criteria:
- Unable to safely participate in outpatient rehabilitation.
- Currently receiving rehabilitation.
- Any participant who has urologic cancer or is enrolled in a competing trial.
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: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: CARE Intervention
This group will be contacted to make an appointment for outpatient Occupational and Physical therapy.
The therapist will determine the type, frequency and length of treatment.
Follow up phone calls will be made to ensure appointments are made, kept and rescheduled as needed.
|
OT and PT will be arranged for the subject and conducted in a manner as determined by the therapist.
|
간섭 없음: CARE Control
Patients randomized to this arm will receive contact information and a brochure outlining the services available within the supportive care program.
The study coordinator will provide the information based on their results and assist the patient with contacting the program if desired.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
To measure the change in Nottingham Extended Activities of Daily Living (NEADL) score from baseline to three months.
기간: 3 months
|
Compare the change in NEADL scores from baseline to 3 months between patients who receive the CARE program (intervention) and those in the control arm.
|
3 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
To measure the change in Activities of Daily Living from Baseline and 2 months
기간: 2 months
|
As measured by the Geriatric Assessment
|
2 months
|
To measure the change in Activities of Daily Living from Baseline and 3 months
기간: 3 months
|
As measured by the Geriatric Assessment
|
3 months
|
To measure the change in physical health from Baseline and 3 months
기간: 3 months
|
As measured by the Geriatric Assessment
|
3 months
|
To measure the change in physical health from Baseline and 2 months
기간: 2 months
|
As measured by the Geriatric Assessment
|
2 months
|
To measure the change in quality of life from Baseline and 2 months
기간: 2 months
|
As measured by the PROMIS assessment
|
2 months
|
To measure the change in quality of life from Baseline and 3 months
기간: 3 months
|
As measured by the PROMIS assessment
|
3 months
|
To measure the change in internalized occupational possibilities from Baseline and 3 months
기간: 3 months
|
As measured by the Possibilities for Activity Scale (PActS)
|
3 months
|
To measure the change in internalized occupational possibilities from Baseline and 2 months
기간: 2 months
|
As measured by the Possibilities for Activity Scale (PActS)
|
2 months
|
To measure the change in cognitive function from Baseline and 2 months
기간: 2 months
|
As measured by the Blessed Memory Orientation Concentration test
|
2 months
|
To measure the change in cognitive function from Baseline and 3 months
기간: 3 months
|
As measured by the Blessed Memory Orientation Concentration test
|
3 months
|
To measure the feasibility of the CARE Program
기간: 3 months
|
To describe the feasibility of the CARE program by reporting enrollment and retention as defined by (1) percent eligible who agree to participate (2) percent in each group that completed follow-up measures at 2 and 3 months and (3) percent of patients in CARE program who go to 70% of appointments.
|
3 months
|
To measure the change in balance over the course of the study
기간: 3 months
|
Intervention Group Only: As measured by the Berg Balance Scale
|
3 months
|
To measure the change in upper extremity use and ability over the course of the study
기간: 3 months
|
Intervention Group Only: As measured by the Disability of the Arm, Shoulder and Hand scale
|
3 months
|
To measure the change in cognition over the course of the study
기간: 3 months
|
Intervention Group Only: As measured by the Montreal Cognitive Assessment
|
3 months
|
To measure the change in dynamic gait ability over the course of the study
기간: 3 months
|
Intervention Group Only: As measured by the Dynamic Gait Index
|
3 months
|
To measure satisfaction with the CARE Program
기간: 3 months
|
To evaluate the program a short interview will be completed with CARE team to determine what worked well, what didn't and suggested changes/improvements for CARE program after completion of project.
|
3 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Mackenzi Pergolotti, PhD, Colorado State University
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)
2014년 6월 1일
기본 완료 (실제)
2017년 3월 1일
연구 완료 (실제)
2017년 3월 1일
연구 등록 날짜
최초 제출
2014년 12월 1일
QC 기준을 충족하는 최초 제출
2014년 12월 2일
처음 게시됨 (추정)
2014년 12월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 9월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 9월 11일
마지막으로 확인됨
2017년 9월 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. .
암에 대한 임상 시험
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
-
University of UtahNational Cancer Institute (NCI)모병피로 | 좌식 생활 | 전이성 전립선암 | IV기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVA기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVB기 전립선암 AJCC(American Joint Committee on Cancer) v8미국
-
Jonsson Comprehensive Cancer Center아직 모집하지 않음전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Rashmi Verma, MDNational Cancer Institute (NCI)모병거세저항성 전립선암 | 전이성 전립선 선암종 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center빼는전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterMiraDX모집하지 않고 적극적으로전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center종료됨거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.종료됨2기 전립선암 AJCC v8 | IIIA기 전립선암 AJCC v8 | IIIB기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | 3기 전립선암 AJCC v8 | IIIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center종료됨생화학적으로 재발하는 전립선암 | 전이성 전립선암 | 뼈의 전이성 악성 신생물 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Assiut University아직 모집하지 않음South Egypt Cancer Institute(SECI)에서 소아 악성종양 환자에 대한 KDIGO 기준을 사용하여 AKI의 누적 발병률을 확인하기 위해
Occupational and Physical Therapy에 대한 임상 시험
-
Training and Implementation Associates모병전통적인 대면 교육 | FTTIP(가족 치료 교육 및 구현 플랫폼)미국