Education With or Without Exercise and Counseling in Preventing Lymphedema in Women With Stage I, Stage II, or Stage III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection
A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer
調査の概要
詳細な説明
OBJECTIVES:
I. To test, in a group randomized controlled trial, the efficacy of this program versus education only in reducing the incidence of lymphedema.
II. To compare the severity of lymphedema, in terms of changes in arm circumference at the site of greatest difference as a continuous variable between the two interventions.
III. To assess the agreement between patients' self-report of swelling (mild, moderate, and severe) and the extent of circumferential measurement difference between the treated side and the contralateral arm at the site of greatest difference.
IV. To compare the health-related quality of life (Factional Assessment of Cancer Therapy-Breast [FACT-B]+4 score) between the two interventions.
V. To characterize adherence to lymphedema prevention exercises, lymphedema knowledge, and range of motion.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.
ARM II: Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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California
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Castro Valley、California、アメリカ、94546
- East Bay Radiation Oncology Center
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Castro Valley、California、アメリカ、94546
- Valley Medical Oncology Consultants - Castro Valley
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Concord、California、アメリカ、94524-4110
- Cancer Care Center at John Muir Health - Concord Campus
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Fremont、California、アメリカ、94538
- Valley Medical Oncology
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Martinez、California、アメリカ、94553-3156
- Contra Costa Regional Medical Center
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Mountain View、California、アメリカ、94040
- El Camino Hospital Cancer Center
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Oakland、California、アメリカ、94609
- Alta Bates Summit Medical Center - Summit Campus
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Oakland、California、アメリカ、94602
- Highland General Hospital
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Oakland、California、アメリカ、94609
- Larry G Strieff MD Medical Corporation
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Oakland、California、アメリカ、94609
- CCOP - Bay Area Tumor Institute
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Oakland、California、アメリカ、94609
- Bay Area Breast Surgeons, Incorporated
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Oakland、California、アメリカ、94609
- Tom K Lee, Incorporated
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San Pablo、California、アメリカ、94806
- Doctors Medical Center - San Pablo Campus
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Walnut Creek、California、アメリカ、94598
- John Muir/Mt. Diablo Comprehensive Cancer Center
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Connecticut
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Bridgeport、Connecticut、アメリカ、06606
- St. Vincent's Medical Center
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Delaware
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Lewes、Delaware、アメリカ、19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark、Delaware、アメリカ、19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington、District of Columbia、アメリカ、20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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Washington、District of Columbia、アメリカ、20002
- Kaiser Permanente at Capitol Hill Medical Center
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Florida
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Deerfield Beach、Florida、アメリカ、33064-3596
- North Broward Medical Center
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Jupiter、Florida、アメリカ、33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
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Miami Beach、Florida、アメリカ、33140
- CCOP - Mount Sinai Medical Center
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Pensacola、Florida、アメリカ、32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Tallahassee、Florida、アメリカ、32308
- Tallahassee Memorial Hospital
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Illinois
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Chicago、Illinois、アメリカ、60637-1470
- University of Chicago Cancer Research Center
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Chicago、Illinois、アメリカ、60631
- Resurrection Medical Center
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Elk Grove Village、Illinois、アメリカ、60007
- Alexian Brothers Radiation Oncology
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Harvey、Illinois、アメリカ、60426
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
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Moline、Illinois、アメリカ、61265
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Moline、Illinois、アメリカ、61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Indiana
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La Porte、Indiana、アメリカ、46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Mishawaka、Indiana、アメリカ、46545-1470
- Saint Joseph Regional Medical Center
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South Bend、Indiana、アメリカ、46601
- Memorial Hospital of South Bend
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South Bend、Indiana、アメリカ、46601
- CCOP - Northern Indiana CR Consortium
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South Bend、Indiana、アメリカ、46601
- Michiana Hematology-Oncology, PC - South Bend
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Iowa
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Bettendorf、Iowa、アメリカ、52722
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Kansas
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Chanute、Kansas、アメリカ、66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City、Kansas、アメリカ、67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado、Kansas、アメリカ、67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott、Kansas、アメリカ、66701
- Cancer Center of Kansas - Fort Scott
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Independence、Kansas、アメリカ、67301
- Cancer Center of Kansas-Independence
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Kingman、Kansas、アメリカ、67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence、Kansas、アメリカ、66044
- Lawrence Memorial Hospital
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Liberal、Kansas、アメリカ、67901
- Cancer Center of Kansas, PA - Liberal
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McPherson、Kansas、アメリカ、67460
- Cancer Center of Kansas, PA - McPherson
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Newton、Kansas、アメリカ、67114
- Cancer Center of Kansas, PA - Newton
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Parsons、Kansas、アメリカ、67357
- Cancer Center of Kansas, PA - Parsons
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Pratt、Kansas、アメリカ、67124
- Cancer Center of Kansas, PA - Pratt
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Salina、Kansas、アメリカ、67401
- Cancer Center of Kansas, PA - Salina
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Wellington、Kansas、アメリカ、67152
- Cancer Center of Kansas, PA - Wellington
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Wichita、Kansas、アメリカ、67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita、Kansas、アメリカ、67214
- Cancer Center of Kansas, PA - Wichita
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Wichita、Kansas、アメリカ、67214
- CCOP - Wichita
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Wichita、Kansas、アメリカ、67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita、Kansas、アメリカ、67208
- Associates in Womens Health, PA - North Review
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Winfield、Kansas、アメリカ、67156
- Cancer Center of Kansas, PA - Winfield
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Kentucky
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Lexington、Kentucky、アメリカ、40503-9985
- Central Baptist Hospital
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Maine
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York、Maine、アメリカ、03909
- York Hospital's Oncology Treatment Center
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Maryland
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Baltimore、Maryland、アメリカ、21244
- Kaiser Permanente at Woodlawn Medical Center
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Elkton、Maryland、アメリカ、21921
- Union Hospital of Cecil County
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Gaithersburg、Maryland、アメリカ、20879
- Kaiser Permanente - Gaithersburg Medical Center
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Largo、Maryland、アメリカ、20774
- Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility
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Silver Spring、Maryland、アメリカ、20910
- Holy Cross Hospital
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Massachusetts
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Boston、Massachusetts、アメリカ、02111
- Tufts Medical Center Cancer Center
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Hyannis、Massachusetts、アメリカ、02601
- Cape Cod Hospital
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New Jersey
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Elizabeth、New Jersey、アメリカ、07207
- Trinitas Comprehensive Cancer Center at Trinitas Hospital
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Voorhees、New Jersey、アメリカ、08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New York
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Staten Island、New York、アメリカ、10305
- Nalitt Cancer Institute at Staten Island University Hospital
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North Carolina
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Greenville、North Carolina、アメリカ、27834
- Leo W. Jenkins Cancer Center at ECU Medical School
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North Dakota
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Fargo、North Dakota、アメリカ、58122
- CCOP - MeritCare Hospital
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Ohio
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Columbus、Ohio、アメリカ、43210-1240
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
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Tennessee
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Cookeville、Tennessee、アメリカ、38501
- Cookeville Regional Medical Center
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Texas
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Houston、Texas、アメリカ、77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Laredo、Texas、アメリカ、78045
- Doctor's Hospital of Laredo
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Virginia
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Fairfax、Virginia、アメリカ、22033
- Kaiser Permanente Medical Center - Fair Oaks
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McLean、Virginia、アメリカ、22102
- Kaiser Permanente Tysons Corner Medical Center
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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
Eligibility Criteria:
- Newly diagnosed with stage I-III cancer of the female breast
No prior history of carcinoma in situ, lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), or invasive breast cancer
* Patients with a history of other invasive malignancies are eligible as long as they have completed treatment and are 5 years post-diagnosis; patients with basal cell and squamous cell cancer of the skin are eligible
Neoadjuvant therapy
- Patients scheduled to receive any type of radiation therapy to the breast or axilla are eligible; however, they must be registered to this study with pre-surgery measures taken prior to receiving neoadjuvant therapy
- Patients scheduled to receive neoadjuvant chemotherapy are also eligible; however, they must be registered to this study with pre-surgery measurements taken prior to receiving neoadjuvant therapy
- Patients receiving no neoadjuvant therapy are eligible
- May be enrolled on other treatment trials; however, patients enrolled on surgery trials where only one treatment arm is full axillary node dissection are not eligible; NOTE: Patients enrolled on American College of Surgeons Oncology Group (ACOSOG)-Z1071 are eligible to participate in this study; patients concurrently enrolled on this study and ACOSOG-Z1071, may not also be enrolled on the ACOSOG-Z1071 lymphedema sub-study
- No documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease which, in the opinion of the treating physician, significantly increases mortality over the next 2 years
- No diagnosed lymphedema
- In order to be properly fitted for the elastic sleeve, eligible patients must have arm measurements for axilla, elbow, and wrist that fall within the ranges for one of the six sleeve sizes
- Not currently homebound or dependent upon a walker or wheelchair for mobility
- Able to participate in a mild exercise program
- Willing to return to the study site for the duration of the study (18 months)
- Sentinel (SND) or full axillary node dissection (AND) (no minimum number of nodes required)
- Patients with double mastectomy, axillary node dissection and/or radiation on both arms are ineligible; patients who undergo these treatments (i.e., surgery and/or radiation) on the contralateral arm after registration to Step 2 are still eligible to remain in the study; however, it should be documented appropriately on form C-1628 at the conclusion of study participation
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 |
---|---|
実験的:Arm I (lymphedema education)
Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials.
Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months.
Patients are also contacted by telephone at 9 and 15 months.
|
Ancillary studies
Receive lymphedema educational materials
他の名前:
|
実験的:Arm II (lymphedema education, physical therapy)
Description Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
|
Ancillary studies
Receive lymphedema educational materials
他の名前:
Complete physical therapy-focused intervention
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 |
---|---|---|
Number of Participants Who Were Lymphedema-free 18 Months After Randomization
時間枠:18 months
|
To test, in a group randomized controlled trial, the efficacy of this program versus education only in reducing the incidence of lymphedema.
Reported here is the proportion of patients who are lymphedema-free 18 months after randomization between the two arms
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18 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference
時間枠:18 months
|
To compare the severity of lymphedema in terms of changes in arm circumference at the site of greatest difference as a continuous variable between the two interventions.
|
18 months
|
Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm
時間枠:18 months
|
To assess the agreement between patients' self-report of swelling (mild, moderation and severe) and the extent of circumferential measurement difference between treated side and the contralateral arm at the site of greatest difference.
Per protocol, this analysis will include all patients and not be comparing the intervention arm with the control arm.
|
18 months
|
Health-related Quality of Life as Assessed by FACT-B +4 Score
時間枠:18 months
|
To compare the health-related quality of life (FACT-B+4 score) between the two interventions.
The change between baseline and month 18 for the total plus 4 score will be reported here.
The total plus 4 score is an average of the physical, social, emotional, functional, FACT-G, and additional concerns sub-scales.
Each sub-scale has questions ranging from 1-5.
Once the average of all subscales is taken, the total plus 4 score is converted into a score out of 100. 100 being the best, 0 being the worst.
|
18 months
|
Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength
時間枠:from baseline up to 18 months
|
To characterize adherence to lymphedema prevention exercises, lymphedema knowledge and range of motion.
The frequency of elastic sleeve use for heavy arm use/exercise/air travel will be reported here.
Arm I did not receive a sleeve to wear, thus will not be reported.
|
from baseline up to 18 months
|
協力者と研究者
捜査官
- スタディチェア:Electra D. Paskett, PhD、Ohio State University Comprehensive Cancer Center
出版物と役立つリンク
一般刊行物
- Paskett ED, Le-Rademacher J, Oliveri JM, Liu H, Seisler DK, Sloan JA, Armer JM, Naughton MJ, Hock K, Schwartz M, Unzeitig G, Melnik M, Yee LD, Fleming GF, Taylor JR, Loprinzi C. A randomized study to prevent lymphedema in women treated for breast cancer: CALGB 70305 (Alliance). Cancer. 2021 Jan 15;127(2):291-299. doi: 10.1002/cncr.33183. Epub 2020 Oct 20.
- Naughton MJ, Liu H, Seisler DK, Le-Rademacher J, Armer JM, Oliveri JM, Sloan JA, Hock K, Schwartz M, Unzeitig G, Melnik M, Yee LD, Fleming GF, Taylor JR, Loprinzi C, Paskett ED. Health-related quality of life outcomes for the LEAP study-CALGB 70305 (Alliance): A lymphedema prevention intervention trial for newly diagnosed breast cancer patients. Cancer. 2021 Jan 15;127(2):300-309. doi: 10.1002/cncr.33184. Epub 2020 Oct 20.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
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。
quality of life assessmentの臨床試験
-
Hürriyet YılmazMedipol University完了
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Bogomolets National Medical University完了
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Pediatric Clinical Research PlatformUniversity Hospital, Geneva; Swiss Federal Institute of Technology; Hôpital du Valais募集
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Bogomolets National Medical University完了