Breast NeoplasmNCT00821288
Post-treatment Care of Breast Cancer Survivors
A study testing Survivorship Intervention and Facing Forward in people with Breast Neoplasm, run by Columbia University at 1 site in United States.
Trial summary
The overall goal of this proposal is to improve the post-treatment care of breast cancer survivors and to understand the barriers to optimal post-treatment care in Latina and Non-Hispanic women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Survivorship Intervention and Facing Forward
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to May 2013
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be screened for the following inclusion criteria:
- Age >18 years
- History of stage 0, I, II, or IIIa breast cancer and no evidence of recurrent disease
- Within 6 weeks of completion of breast cancer therapy (Surgery, Radiation or Chemotherapy)
- Caucasian and/or Hispanic (English or Spanish-speaking)
- Willing to undergo a 1 hr cancer survivorship evaluation
Who cannot join
- Patients with the following active conditions or behaviors will be excluded from participation:
- Evidence of recurrent or metastatic breast cancer
- Patients who have received surgery only with no adjuvant therapy
- Uncontrolled or significant psychiatric illness/social situations that would preclude completion of questionnaire or follow-up evaluation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia Unviersity Medical Center
New York, New York, 10032
About this study
The overall goal of this proposal is to improve the post-treatment care of breast cancer survivors and to understand the barriers to optimal post-treatment care in Latina and Non-Hispanic women.
Read the detailed description
The proposed investigation is a randomized prospective evaluation of a Survivorship Intervention in improving the quality of care, treatment satisfaction and understanding of care in Latina and Caucasian breast cancer survivors treated in an urban academic medical center. Patients will be recruited within 6 weeks of completing their last definitive breast cancer therapy (radiation or chemotherapy). Patients will complete self administered baseline and follow-up questionnaires. Following baseline evaluation patients will be randomized to receiving either written information for follow-up care of cancer survivors published by the National Cancer Institute (Facing Forward), or the Survivorship Intervention. Patients will not be aware that they are participating in a randomized intervention. After verbally agreeing to participate they will be randomized to group A or B and will receive the corresponding consent. Patients will be re-assessed 3 and 6 months after enrollment.
- Conditions
- Breast Neoplasm
- Being tested
- Survivorship Intervention, Facing Forward
- Keywords
- cancer survivorship, survivorship prescription, cancer related anxiety
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survivorship InterventionBehavioural
Also called Survivorship Prescription
Survivorship Consultation is a one hour consultation in a survivorship clinic. The consultation will be performed by a nurse practitioner under the supervision of a medical oncologist. The consultation will result in a detailed written document outlining the individuals "Survivorship Prescription" including treatment summary, surveillance recommendations, risk for late-effects, cancer screening recommendations, genetic risk, and life style recommendations. This written document will be provided to the patient and her treating physician. In addition, referrals will be made to appropriate adjunct services as needed (e.g. psychologist, nutritionist, social worker).
Facing ForwardBehavioural
Also called Life after Cancer Treatment manual
Facing Forward: Life after Cancer Treatment is a guide for people who were treated for cancer published by the NCI. It is a 24-page manual that summarized many key issues of interest to cancer survivors during the re-entry phase, and contains sections on medical care after treatment, symptoms after treatment, feelings after treatment, social relationships after cancer treatment, and dealing with practical matters such as insurance and employment. The manual is available in English and Spanish. This will be given at the time of registration and the table of contents will be reviewed with the patient.
| Study group | Role | What they receive |
|---|---|---|
| Survivorship Intervention | Experimental | Latina and Caucasian breast cancer survivors treated in an urban academic medical center receiving Survivorship Intervention Receives: Behavioral: Survivorship Intervention |
| Facing Forward | Active comparator | Latina and Caucasian breast cancer survivors treated in an urban academic medical center receiving Survivorship Intervention Facing Forward: Life after Cancer Treatment manual Receives: Behavioral: Facing Forward |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FACIT-TS questionnaire score
This is designed to measure change in positive health related behavior.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startJul 2007
- Primary completionOct 2011
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Responsible party
- Principal investigator, Dawn L. Hershman, Columbia University
- Investigators
- Dawn L Hershman, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821288
- Sponsor's protocol ID
- AAAC5741
- Other IDs
- DISP0706868
- Status last verified
- Jun 2017
- First submitted
- 12 Jan 2009
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hershman DL, Greenlee H, Awad D, Kalinsky K, Maurer M, Kranwinkel G, Brafman L, Jayasena R, Tsai WY, Neugut AI, Crew KD. Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors. Breast Cancer Res Treat. 2013 Apr;138(3):795-806. doi: 10.1007/s10549-013-2486-1. Epub 2013 Mar 31.
PubMed 23542954
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-treatment Care of Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT00821288
- Acronym / sponsor ID
- AAAC5741
- Conditions
- Breast Neoplasm
- Keywords
- cancer survivorship, survivorship prescription, cancer related anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Study start
- Jul 2007 (actual)
- Primary completion
- Oct 2011 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 13 Jan 2009 (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.
The overall goal of this proposal is to improve the post-treatment care of breast cancer survivors and to understand the barriers to optimal post-treatment care in Latina and Non-Hispanic women.
Detailed description
The proposed investigation is a randomized prospective evaluation of a Survivorship Intervention in improving the quality of care, treatment satisfaction and understanding of care in Latina and Caucasian breast cancer survivors treated in an urban academic medical center. Patients will be recruited within 6 weeks of completing their last definitive breast cancer therapy (radiation or chemotherapy). Patients will complete self administered baseline and follow-up questionnaires. Following baseline evaluation patients will be randomized to receiving either written information for follow-up care of cancer survivors published by the National Cancer Institute (Facing Forward), or the Survivorship Intervention. Patients will not be aware that they are participating in a randomized intervention. After verbally agreeing to participate they will be randomized to group A or B and will receive the corresponding consent. Patients will be re-assessed 3 and 6 months after enrollment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivorship Intervention | Experimental | Behavioral: Survivorship InterventionLatina and Caucasian breast cancer survivors treated in an urban academic medical center receiving Survivorship Intervention |
| Facing Forward | Active comparator | Behavioral: Facing ForwardLatina and Caucasian breast cancer survivors treated in an urban academic medical center receiving Survivorship Intervention Facing Forward: Life after Cancer Treatment manual |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants will be screened for the following inclusion criteria:
- Age >18 years
- History of stage 0, I, II, or IIIa breast cancer and no evidence of recurrent disease
- Within 6 weeks of completion of breast cancer therapy (Surgery, Radiation or Chemotherapy)
- Caucasian and/or Hispanic (English or Spanish-speaking)
Key exclusion criteria (4 listed)
- Patients with the following active conditions or behaviors will be excluded from participation:
- Evidence of recurrent or metastatic breast cancer
- Patients who have received surgery only with no adjuvant therapy
- Uncontrolled or significant psychiatric illness/social situations that would preclude completion of questionnaire or follow-up evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survivorship InterventionAlso: Survivorship PrescriptionSurvivorship Consultation is a one hour consultation in a survivorship clinic. The consultation will be performed by a nurse practitioner under the supervision of a medical oncologist. The consultation will result in a detailed written document outlining the individuals "Survivorship Prescription" including treatment summary, surveillance recommendations, risk for late-effects, cancer screening recommendations, genetic risk, and life style recommendations. This written document will be provided to the patient and her treating physician. In addition, referrals will be made to appropriate adjunct services as needed (e.g. psychologist, nutritionist, social worker). | Behavioural | Survivorship Intervention |
| Facing ForwardAlso: Life after Cancer Treatment manualFacing Forward: Life after Cancer Treatment is a guide for people who were treated for cancer published by the NCI. It is a 24-page manual that summarized many key issues of interest to cancer survivors during the re-entry phase, and contains sections on medical care after treatment, symptoms after treatment, feelings after treatment, social relationships after cancer treatment, and dealing with practical matters such as insurance and employment. The manual is available in English and Spanish. This will be given at the time of registration and the table of contents will be reviewed with the patient. | Behavioural | Facing Forward |
Primary outcome
Change in FACIT-TS questionnaire score
Time frame: Baseline, 6 months
This is designed to measure change in positive health related behavior.
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 19 Jun 2017.
- Derived from this study: PubMed 23542954Hershman DL, Greenlee H, Awad D, Kalinsky K, Maurer M, Kranwinkel G, Brafman L, Jayasena R, Tsai WY, Neugut AI, Crew KD. Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors. Breast Cancer Res Treat. 2013 Apr;138(3):795-806. doi: 10.1007/s10549-013-2486-1. Epub 2013 Mar 31.
- Individual participant dataSharing planned: Undecided
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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.
Dawn L Hershman, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survivorship Intervention and Facing Forward in people with Breast Neoplasm, run by Columbia University 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 6 inclusion and 4 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 19 Jun 2017. 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?
Change in FACIT-TS questionnaire score (time frame: Baseline, 6 months). 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 NCT00821288, which also lists 1 linked publication.
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 19 Jun 2017.