Ignite Creation Date:
2024-05-06 @ 12:38 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01627366
Status:
COMPLETED
Last Update Posted:
2016-08-01
First Post:
2012-06-04
Brief Title:
Study of Survivorship Care Plans and Outcomes in Underserved Breast Cancer Survivors
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Survivorship Plans and Outcomes in Underserved Breast Cancer Survivors RCT
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Improvements in early detection and successful treatment of breast cancer have lead to a steady rise in the number of breast cancer BC survivors With so many individuals living for extended periods after diagnosis the Institute of Medicine IOM recommends the implementation of treatment summaries and survivorship care plans TSSPs as a mechanism to improve ongoing clinical and coordination of care and to address the immediate post-treatment and long-term effects of cancer treatment including the ongoing psychosocial burden of a cancer diagnosis The need for TSSPs has also been strongly advocated by the American Society of Clinical Oncologys Quality Oncology Practice Initiative and TSSPs have been included in the recently introduced Comprehensive Cancer Improvement Act HR 1844 This will be one of the first randomized controlled trials to test the efficacy of TSSPs
The investigators will recruit 500 low income medically underserved women from two county public hospitals LACUSC Medical Center and Harbor-UCLA Medical Center 10-24 months after breast cancer diagnosis for participation in a randomized controlled trial RCT designed to test the efficacy of TSSPs The investigators will randomize these women into one of two groups 1 a control condition of usual medical care and 2 an experimental condition of the control condition a tailored TSSP 1 face-to-face nurse counseling session with all cancer specialists and primary care physicians of record also receiving the TSSP and a cover letter suggesting how they can be clinically utilized
The investigators specific aims are to assess and compare between experimental and control groups the following primary outcomes at one year post-intervention 1 discussion and implementation of recommended breast cancer survivorship care including surveillance and the evaluation and management of BC treatment-related symptoms 2 patient satisfaction with survivorship communication and care 3 pertinent aspects of health-related quality of life and further to then 4 assess the cost-consequences of the experimental intervention This study will provide a unique opportunity to assess the efficacy of TSSPs in a low-income underserved population of BC survivors known to be at high risk for poorer long-term outcomes including in mental health quality of life recurrence and mortality and will therefore allow us to demonstrate the greatest possible benefit of such an intervention
The investigators will recruit 500 low income medically underserved women from two county public hospitals LACUSC Medical Center and Harbor-UCLA Medical Center 10-24 months after breast cancer diagnosis for participation in a randomized controlled trial RCT designed to test the efficacy of TSSPs The investigators will randomize these women into one of two groups 1 a control condition of usual medical care and 2 an experimental condition of the control condition a tailored TSSP 1 face-to-face nurse counseling session with all cancer specialists and primary care physicians of record also receiving the TSSP and a cover letter suggesting how they can be clinically utilized
The investigators specific aims are to assess and compare between experimental and control groups the following primary outcomes at one year post-intervention 1 discussion and implementation of recommended breast cancer survivorship care including surveillance and the evaluation and management of BC treatment-related symptoms 2 patient satisfaction with survivorship communication and care 3 pertinent aspects of health-related quality of life and further to then 4 assess the cost-consequences of the experimental intervention This study will provide a unique opportunity to assess the efficacy of TSSPs in a low-income underserved population of BC survivors known to be at high risk for poorer long-term outcomes including in mental health quality of life recurrence and mortality and will therefore allow us to demonstrate the greatest possible benefit of such an intervention
Detailed Description:
According to the National Cancer Institute NCI there are over 11 million cancer survivors in the United States Among survivors breast cancer BC is the most common with BC survivors accounting for 23 approximately 25 million A 2006 report by the Institute of Medicine IOM From Cancer Patient to Cancer Survivor Lost in Transition provided a comprehensive assessment of the health needs of cancer survivors including a recommendation for the implementation of treatment summaries and survivorship care plans TSSPs to promote coordinated care for cancer survivors and to address the immediate post-treatment and long-term effects of cancer treatment including the ongoing psychosocial burden of a cancer diagnosis as well as the potential for later sequelae of treatment Because of the ever increasing number of BC survivors the fact that 98 of patients with local stage and 84 of patients with regional stage survive for at least 5 years after diagnosis and the multimodal nature of BC treatment providing a mechanism that summarizes monitors and coordinates BC follow-up care and treatment is essential The use of TSSPs has also been strongly advocated by the American Society of Clinical Oncologys ASCO - Quality Oncology Practice Initiative and TSSPs have been included in the recently introduced Comprehensive Cancer Improvement Act of 2009 HR 1844 Further it is apparent that patients themselves strongly desire written follow-up plans after treatment is ended The IOM recommended that research should be undertaken to evaluate the impact and costs of such plans To our knowledge however no randomized controlled trials of TSSPs or evaluations of their cost-effectiveness have been conducted in a low-income medically underserved population
In the proposed study we will recruit 500 low income medically underserved women from two county public hospitals Los Angeles County University of Southern California Medical Center LACUSC Medical Center and Harbor-UCLA Medical Center 10-24 months after breast cancer diagnosis for participation in a randomized control trial RCT designed to test the efficacy of TSSPs The intervention will be delivered after collection of pre-intervention baseline measures We will consent and randomize these women into one of two groups 1 a control condition of usual medical care and 2 an experimental condition of usual medical care tailored materials which includes the TSSP 1 face-to-face nurse counseling session with all cancer specialist and primary care physicians of record also receiving the TSSP and a cover letter suggesting how it is to be clinically utilized The study will provide a unique opportunity to assess the feasibility and clinical utility of a tailored treatment summary and survivorship care plan in a vulnerable population of BC survivors known to be at high risk for poorer long-term outcomes including in mental health quality of life BC recurrence and mortality and will therefore allow us to obtain the greatest possible effect size of such an intervention
We will conduct a randomized controlled trial to test the efficacy of Treatment Summaries and Survivorship Care Plans and accompanying nurse counseling The TSSP will consist of 4 sections 1 the breast cancer treatment summary and 2 a cognitively appropriate survivorship care plan including recommendations for follow-up breast cancer care for both the patient and the physician 3 a special section targeted towards the physician and 4 a list of local and national patient resources
Those women who consent to participate will have pre-intervention measures collected ie the baseline interview and will be randomized to either the usual care condition or the experimental condition Individuals in the experimental group will participate in a face-to-face session with a trained bilingual nurse to review the contents of the TSSP Follow-up measures on all participants will be collected at 12-months after delivery of the intervention We will evaluate receipt of recommended breast cancer survivorship care patient self-efficacy and satisfaction with communication with providers health related quality of life and cost-effectiveness of the intervention In addition all participants in the control group will receive a written copy of their individualized TSSP at the completion of the study
In the proposed study we will recruit 500 low income medically underserved women from two county public hospitals Los Angeles County University of Southern California Medical Center LACUSC Medical Center and Harbor-UCLA Medical Center 10-24 months after breast cancer diagnosis for participation in a randomized control trial RCT designed to test the efficacy of TSSPs The intervention will be delivered after collection of pre-intervention baseline measures We will consent and randomize these women into one of two groups 1 a control condition of usual medical care and 2 an experimental condition of usual medical care tailored materials which includes the TSSP 1 face-to-face nurse counseling session with all cancer specialist and primary care physicians of record also receiving the TSSP and a cover letter suggesting how it is to be clinically utilized The study will provide a unique opportunity to assess the feasibility and clinical utility of a tailored treatment summary and survivorship care plan in a vulnerable population of BC survivors known to be at high risk for poorer long-term outcomes including in mental health quality of life BC recurrence and mortality and will therefore allow us to obtain the greatest possible effect size of such an intervention
We will conduct a randomized controlled trial to test the efficacy of Treatment Summaries and Survivorship Care Plans and accompanying nurse counseling The TSSP will consist of 4 sections 1 the breast cancer treatment summary and 2 a cognitively appropriate survivorship care plan including recommendations for follow-up breast cancer care for both the patient and the physician 3 a special section targeted towards the physician and 4 a list of local and national patient resources
Those women who consent to participate will have pre-intervention measures collected ie the baseline interview and will be randomized to either the usual care condition or the experimental condition Individuals in the experimental group will participate in a face-to-face session with a trained bilingual nurse to review the contents of the TSSP Follow-up measures on all participants will be collected at 12-months after delivery of the intervention We will evaluate receipt of recommended breast cancer survivorship care patient self-efficacy and satisfaction with communication with providers health related quality of life and cost-effectiveness of the intervention In addition all participants in the control group will receive a written copy of their individualized TSSP at the completion of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None