Breast CancerNCT00027105
Morbidity Following the Diagnosis and Treatment of Patients With Breast Cancer
An observational study of Breast Cancer and Lymphedema, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This study will examine the frequency and severity of problems in women with breast cancer during the first year after initial medical treatment, including: Physical impairments, such as loss of strength or flexibility, increased weight and swelling Symptom distress, such as pain, fatigue and weakness. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Breast Cancer, Lymphedema, Physical Therapy
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2001to 17 Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Population/Subjects: Individuals with breast cancer are identified among the patient population at National Naval Medical Center (NNMC). Patients referred to the NNMC Breast Care Center (NNMC-BCC) for diagnosis and management (surgical treatment and radiation treatment or chemotherapy) of histologically established breast cancer (stage I, II, III, or IV) during 2000-2001, are eligible to participate in the study.
- Subjects must be over age 18. This age ensures they are post-puberty as breast cancer does not occur prior to puberty; and been seen pre-surgical or medical intervention for baseline measurements and agree to participate in five follow-up visits of 30 minutes in duration during the next year.
Who cannot join
- Subject's medical records are unavailable and clinical examination forms are incomplete.
- Subjects choose not to participate in the study.
- Subjects are unable to complete the questionnaires.
- Subjects are under age 18.
- Men are not excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Morbidity Following the Diagnosis and Treatment of Patients With Breast Cancer: A Multi-Institutional Study Between the National Institutes of Health (NIH) Rehabilitation Medicine Department (RMD) and the Walter Reed National Military Medical Center (WRNMMC) Breast Care Center
This study will examine the frequency and severity of problems in women with breast cancer during the first year after initial medical treatment, including:
- Physical impairments, such as loss of strength or flexibility, increased weight and swelling
- Symptom distress, such as pain, fatigue and weakness.
- Functional limitations and disabilities, such as loss of independence in activities of daily living (e.g., grooming, bathing, dressing, driving a car), work and social and recreational activities.
Read more
It will identify factors associated with these problems and try to determine their relationship to them.
Patients 18 years of age and older with stage I, II, III or IV breast cancer may be eligible for this study. Participants will be drawn from patients referred to the National Naval Medical Center for diagnosis and treatment during 2000-20001.
Participants will be interviewed and their medical records reviewed for past medical history, history of the present illness and social and recreational history. They will be seen five times over a 1-year period (initial visit and at 3, 6, 9, and 12 months), for 30-minute visits, which will include the following:
- Interview about past medical history and present illness, social and recreational activities, functional independence at work and during activities of daily living.
- Complete health survey and upper limb disability questionnaire; physical activity questionnaire to be completed at 6 and 12 months after medical treatment begins. The questionnaires take about 30 to 40 minutes to complete.
- Upper body examination, including pain measurement using a 10-point scale, an upper limb lift test, and measures of upper limb volume and girth.
Read the detailed description
This retrospective (case-control) outcome study will investigate the frequency and severity of morbidities in a population of approximately 160 patients diagnosed with breast cancer before and after medical and surgical treatment. Subjects will be followed for one-year with quarterly examinations (baseline [pre-medical treatment] and at 1, 3 months, 6 months, 9 months and 12 months after treatment). In order for cancer survivors to understand the risk of impairment and functional limitations, and disability; and for health care providers to determine the risk of physical impairment, functional limitations, and loss of independence (morbidity) in patients with breast cancer; it is necessary to study these patients from the point of diagnosis (before surgery) to a reasonable period following the completion of the primary treatment program (1 year after medical treatment). Although pain, numbness, fatigue, lymphedema and diminished physical function are described as prevalent and debilitating conditions, remarkably few clinical studies are published describing the associated physical impairments, functional limitations or on methods for their control with measures prior to medical intervention and long-term follow-up. While several past reports have identified the impact of medical and surgical intervention on symptom distress and functional capacity of these patients, these studies do not provide sufficient evidence to identify the: 1) level of physical impairment that predicts morbidity in these patients, 2) individual factors that are specific predictors of morbidity in these patients, or 3) time period in which these morbidities occur. The majority of previous studies investigating morbidity of patients with breast cancer following medical and surgical intervention are cross-sectional, case series, retrospective analysis without a comparison/control group and without baseline measures prior to intervention. The proposed outcome study will include: 1) a retrospective review of specific medical record information such as staging conference information and the standard clinical quarterly examination during a one year period, and 2) administration of a follow-up outcome questionnaire, a physical activity questionnaire and a quality of life questionnaire at the 6 and 12 months time points. The outcome survey is an upper limb disability questionnaire developed as an outcome measure for this project. Data available in these measurement domains will allow the researchers to determine the: 1) frequency and severity of: a) symptom distress (fatigue, pain including chronic pain, aching, weakness, burning, tingling, numbness, anxiety, and depression) and pathological conditions (adhesive capsulitis, weakness and atrophy, neuropathy, scar/skin adhesions, lymphedema), b) physical impairments (diminished upper extremity and trunk range of motion/flexibility, strength, coordination and increased girth), and c) functional imitations and disabilities during the course of the medical treatment (loss of independence in or ability to perform routine activities of daily living i.e., grooming, bathing, dressing, driving an automobile, and in some cases, return to their regular work, recreational and social activities). 2) level of impairment at which these patients have lost independence in function and identity those patients at higher risk for the loss of independence in function (e.g., ADL's).
- Conditions
- Breast Cancer, Lymphedema, Physical Therapy, Shoulder
- Keywords
- Fatigue, Shoulder function, Lymphedema, Breast Cancer, Breast Cancer Surgery, Quality of Life
- Medical subject headings
- Breast Neoplasms, Lymphedema, Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper limb strength
Measured: 1,3,6,9,12,60 months
Range of motion
Measured: 1,3,6,9,12,60 month
Upper limb volume
Measured: 1,3,6,9,12,60 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2001 (estimated)
- Study start16 Nov 2001
- Study completion17 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Minal Jain, R.P.T., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027105
- Sponsor's protocol ID
- 020044
- Other IDs
- 02-CC-0044
- Status last verified
- 17 Aug 2016
- First submitted
- 20 Nov 2001
- Last updated
- 12 Dec 2019
- Results posted
- No
Publications
King KB, Nail LM, Kreamer K, Strohl RA, Johnson JE. Patients' descriptions of the experience of receiving radiation therapy. Oncol Nurs Forum. 1985 Jul-Aug;12(4):55-61. No abstract available.
PubMed 3847996Meyerowitz BE, Watkins IK, Sparks FC. Quality of life for breast cancer patients receiving adjuvant chemotherapy. Am J Nurs. 1983 Feb;83(2):232-5. No abstract available.
PubMed 6549885Carter BJ. Women's experiences of lymphedema. Oncol Nurs Forum. 1997 Jun;24(5):875-82.
PubMed 9201739
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbidity Following the Diagnosis and Treatment of Patients With Breast Cancer: A Multi-Institutional Study Between the National Institutes of Health (NIH) Rehabilitation Medicine Department (RMD) and the Walter Reed National Military Medical Center (WRNMMC) Breast Care Center
- ClinicalTrials.gov ID
- NCT00027105
- Acronym / sponsor ID
- 020044
- Conditions
- Breast Cancer, Lymphedema, Physical Therapy, Shoulder
- Keywords
- Fatigue, Shoulder function, Lymphedema, Breast Cancer, Breast Cancer Surgery, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 16 Nov 2001
- Study completion
- 17 Aug 2016
- First posted
- 21 Nov 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the frequency and severity of problems in women with breast cancer during the first year after initial medical treatment, including:
- Physical impairments, such as loss of strength or flexibility, increased weight and swelling
- Symptom distress, such as pain, fatigue and weakness.
- Functional limitations and disabilities, such as loss of independence in activities of daily living (e.g., grooming, bathing, dressing, driving a car), work and social and recreational activities.
It will identify factors associated with these problems and try to determine their relationship to them.
Patients 18 years of age and older with stage I, II, III or IV breast cancer may be eligible for this study. Participants will be drawn from patients referred to the National Naval Medical Center for diagnosis and treatment during 2000-20001.
Participants will be interviewed and their medical records reviewed for past medical history, history of the present illness and social and recreational history. They will be seen five times over a 1-year period (initial visit and at 3, 6, 9, and 12 months), for 30-minute visits, which will include the following:
- Interview about past medical history and present illness, social and recreational activities, functional independence at work and during activities of daily living.
- Complete health survey and upper limb disability questionnaire; physical activity questionnaire to be completed at 6 and 12 months after medical treatment begins. The questionnaires take about 30 to 40 minutes to complete.
- Upper body examination, including pain measurement using a 10-point scale, an upper limb lift test, and measures of upper limb volume and girth.
Detailed description
This retrospective (case-control) outcome study will investigate the frequency and severity of morbidities in a population of approximately 160 patients diagnosed with breast cancer before and after medical and surgical treatment. Subjects will be followed for one-year with quarterly examinations (baseline [pre-medical treatment] and at 1, 3 months, 6 months, 9 months and 12 months after treatment). In order for cancer survivors to understand the risk of impairment and functional limitations, and disability; and for health care providers to determine the risk of physical impairment, functional limitations, and loss of independence (morbidity) in patients with breast cancer; it is necessary to study these patients from the point of diagnosis (before surgery) to a reasonable period following the completion of the primary treatment program (1 year after medical treatment). Although pain, numbness, fatigue, lymphedema and diminished physical function are described as prevalent and debilitating conditions, remarkably few clinical studies are published describing the associated physical impairments, functional limitations or on methods for their control with measures prior to medical intervention and long-term follow-up. While several past reports have identified the impact of medical and surgical intervention on symptom distress and functional capacity of these patients, these studies do not provide sufficient evidence to identify the: 1) level of physical impairment that predicts morbidity in these patients, 2) individual factors that are specific predictors of morbidity in these patients, or 3) time period in which these morbidities occur. The majority of previous studies investigating morbidity of patients with breast cancer following medical and surgical intervention are cross-sectional, case series, retrospective analysis without a comparison/control group and without baseline measures prior to intervention. The proposed outcome study will include: 1) a retrospective review of specific medical record information such as staging conference information and the standard clinical quarterly examination during a one year period, and 2) administration of a follow-up outcome questionnaire, a physical activity questionnaire and a quality of life questionnaire at the 6 and 12 months time points. The outcome survey is an upper limb disability questionnaire developed as an outcome measure for this project. Data available in these measurement domains will allow the researchers to determine the: 1) frequency and severity of: a) symptom distress (fatigue, pain including chronic pain, aching, weakness, burning, tingling, numbness, anxiety, and depression) and pathological conditions (adhesive capsulitis, weakness and atrophy, neuropathy, scar/skin adhesions, lymphedema), b) physical impairments (diminished upper extremity and trunk range of motion/flexibility, strength, coordination and increased girth), and c) functional imitations and disabilities during the course of the medical treatment (loss of independence in or ability to perform routine activities of daily living i.e., grooming, bathing, dressing, driving an automobile, and in some cases, return to their regular work, recreational and social activities). 2) level of impairment at which these patients have lost independence in function and identity those patients at higher risk for the loss of independence in function (e.g., ADL's).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Population/Subjects: Individuals with breast cancer are identified among the patient population at National Naval Medical Center (NNMC). Patients referred to the NNMC Breast Care Center (NNMC-BCC) for diagnosis and management (surgical treatment and radiation treatment or chemotherapy) of histologically established breast cancer (stage I, II, III, or IV) during 2000-2001, are eligible to participate in the study.
- Subjects must be over age 18. This age ensures they are post-puberty as breast cancer does not occur prior to puberty; and been seen pre-surgical or medical intervention for baseline measurements and agree to participate in five follow-up visits of 30 minutes in duration during the next year.
Key exclusion criteria (5 listed)
- Subject's medical records are unavailable and clinical examination forms are incomplete.
- Subjects choose not to participate in the study.
- Subjects are unable to complete the questionnaires.
- Subjects are under age 18.
- Men are not excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Upper limb strength
Time frame: 1,3,6,9,12,60 months
Range of motion
Time frame: 1,3,6,9,12,60 month
Upper limb volume
Time frame: 1,3,6,9,12,60 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Background: PubMed 3847996King KB, Nail LM, Kreamer K, Strohl RA, Johnson JE. Patients' descriptions of the experience of receiving radiation therapy. Oncol Nurs Forum. 1985 Jul-Aug;12(4):55-61. No abstract available.
- Background: PubMed 6549885Meyerowitz BE, Watkins IK, Sparks FC. Quality of life for breast cancer patients receiving adjuvant chemotherapy. Am J Nurs. 1983 Feb;83(2):232-5. No abstract available.
- Background: PubMed 9201739Carter BJ. Women's experiences of lymphedema. Oncol Nurs Forum. 1997 Jun;24(5):875-82.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minal Jain, R.P.T. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Lymphedema, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper limb strength (time frame: 1,3,6,9,12,60 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00027105, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.