Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416572
Status:
COMPLETED
Last Update Posted:
2016-11-06
First Post:
2006-12-27
Brief Title:
Educational Program in Younger Women Who Have Recently Finished Treatment for Stage I or Stage II Breast Cancer
Sponsor:
Carnegie Mellon University
Organization:
Carnegie Mellon University
Study Overview
Official Title:
Adjustment to Breast Cancer Among Younger Women
Status:
COMPLETED
Status Verified Date:
2016-09
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:
RATIONALE Educational programs may improve coping and quality of life in younger women who have recently been treated for early-stage breast cancer
PURPOSE To conduct a clinical trial to determine if an educational intervention and a nutritional intervention could enhance physical and psychological functioning among younger women completing treatment for early-stage breast cancer
PURPOSE To conduct a clinical trial to determine if an educational intervention and a nutritional intervention could enhance physical and psychological functioning among younger women completing treatment for early-stage breast cancer
Detailed Description:
OBJECTIVES
Design implement and evaluate an educational intervention and a nutrition education intervention specifically aimed at improving adjustment among younger women who have been newly diagnosed with and treated for stage I or II breast cancer and who are ending the active phase of treatment
Determine the processes through which the interventions affect quality of life
Assess whether the interventions are differentially effective for different groups of women
Determine how women who decline participation differ from those who participate
Determine the nature and extent of adjustment difficulties using baseline data in younger women living in an urban setting who have been treated for early stage breast cancer
Identify personality and situational correlates of individuals who adapt well to early-stage breast cancer diagnosis and treatment and those who do not
OUTLINE This is a randomized study Patients are randomized to 1 of 2 intervention groups or a control condition
Arm I control group Patients did not undergo any intervention Patients were evaluated at baseline and at 4 and 13 months
Arm II breast cancer education group Patients attended a series of approximately 2-hour-long breast cancer education group sessions once a month for 4 months Sessions involved the presentation of information concerning breast cancer followed by a guided discussion of related topics Sessions topics included talking with children about cancer life after diagnosis relationshipsintimacy and hormones and breast cancerbasic factors of heredity Patients were also given booklets and brochures to read at home Patients were evaluated at baseline immediately after the intervention and at 9 months after the intervention
Arm III nutritional education group Patients attended a series of approximately 2-hour-long nutritional education group sessions once a month for 4 months Sessions involved the presentation of information concerning nutrition followed by a guided discussion of related topics Session topics included healthy cupboards whats cooking shopping for success and out on the town Patients were also asked to keep a 4 day record of diet Patients were evaluated at baseline immediately after the intervention and at 9 months after the intervention
Design implement and evaluate an educational intervention and a nutrition education intervention specifically aimed at improving adjustment among younger women who have been newly diagnosed with and treated for stage I or II breast cancer and who are ending the active phase of treatment
Determine the processes through which the interventions affect quality of life
Assess whether the interventions are differentially effective for different groups of women
Determine how women who decline participation differ from those who participate
Determine the nature and extent of adjustment difficulties using baseline data in younger women living in an urban setting who have been treated for early stage breast cancer
Identify personality and situational correlates of individuals who adapt well to early-stage breast cancer diagnosis and treatment and those who do not
OUTLINE This is a randomized study Patients are randomized to 1 of 2 intervention groups or a control condition
Arm I control group Patients did not undergo any intervention Patients were evaluated at baseline and at 4 and 13 months
Arm II breast cancer education group Patients attended a series of approximately 2-hour-long breast cancer education group sessions once a month for 4 months Sessions involved the presentation of information concerning breast cancer followed by a guided discussion of related topics Sessions topics included talking with children about cancer life after diagnosis relationshipsintimacy and hormones and breast cancerbasic factors of heredity Patients were also given booklets and brochures to read at home Patients were evaluated at baseline immediately after the intervention and at 9 months after the intervention
Arm III nutritional education group Patients attended a series of approximately 2-hour-long nutritional education group sessions once a month for 4 months Sessions involved the presentation of information concerning nutrition followed by a guided discussion of related topics Session topics included healthy cupboards whats cooking shopping for success and out on the town Patients were also asked to keep a 4 day record of diet Patients were evaluated at baseline immediately after the intervention and at 9 months after the intervention
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01CA064711 | NIH | None | httpsreporternihgovquickSearch5R01CA064711 |