Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372840
Status:
COMPLETED
Last Update Posted:
2020-03-02
First Post:
2006-09-06
Brief Title:
Printed Education Materials in Patients Who Are Finishing Treatment for Stage I Stage II or Stage IIIA Breast Cancer Colorectal Cancer Prostate Cancer or Chest Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Efficacy and Feasibility of a Psychosocial Intervention Within the CCOP Context Evaluation of the Facing Forward Guide to Facilitate Life After Active Cancer Treatment
Status:
COMPLETED
Status Verified Date:
2020-02
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 Printed educational materials such as the Facing Forward Series Life After Cancer Treatment manual may help make the transition from cancer patient to cancer survivor easier in patients who are finishing treatment for cancer It is not yet known if the Facing Forward Series Life After Cancer Treatment manual and The Cancer Information Service Questions and Answers fact sheet is more effective than the The Cancer Information Service Questions and Answers fact sheet alone in helping to make life after cancer treatment easier and to improve quality of life in patients with breast cancer colorectal cancer prostate cancer or chest cancer
PURPOSE This randomized clinical trial is studying how well printed education materials work in assisting patients who are finishing treatment for stage I stage II or stage IIIA breast cancer colorectal cancer prostate cancer or chest cancer to make the transition from cancer patient to cancer survivor easier
PURPOSE This randomized clinical trial is studying how well printed education materials work in assisting patients who are finishing treatment for stage I stage II or stage IIIA breast cancer colorectal cancer prostate cancer or chest cancer to make the transition from cancer patient to cancer survivor easier
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of a psychoeducational intervention comprising a specific print intervention manual Facing Forward Series Life After Cancer Treatment Facing Forward manual and a general print intervention fact sheet The Cancer Information Service Questions and Answers vs the general print intervention fact sheet only on the uptake of recommended actions eg developing a wellness plan after treatment dealing with pain and fatigue finding support groups to deal with feelings after treatment and dealing with family issues after treatment in patients completing active treatment for stage I-IIIA breast prostate colorectal or thoracic cancer
Explore patient process evaluations of the Facing Forward manual in terms of its usability comprehension and satisfaction
Secondary
Examine psychological outcomes ie depressive symptoms fear of recurrence health-related quality of life and self-efficacy as a function of exposure to the Facing Forward manual
OUTLINE This is a multicenter randomized controlled open-label cohort study Patients are stratified according to participating center prior chemotherapy yes vs no and type of cancer breast vs colorectal vs prostate vs thoracic Patients are randomized to 1 of 2 arms
Arm I intervention Patients receive a specific print intervention manual entitled Facing Forward Series Life After Cancer Treatment and a general print intervention fact sheet entitled The Cancer Information Service Questions and Answers
Arm II control Patients receive the general print intervention fact sheet entitled The Cancer Information Service Questions and Answers
In both arms patients are evaluated at baseline within 18 days of the patients final cancer treatment visit 8 weeks via mailed home materials and then at 6 months via mailed home materials Baseline evaluations include background information ie demographics and medical status baseline use of educational materials survivorship activities and psychological factors ie depressive symptoms quality of life fear of recurrence and self-efficacy Psychological factors are also reassessed at 8 weeks and 6 months as well as use of educational materials and survivorship activities
For patients in both arms uptake of recommended actions are reassessed Patients in arm I complete ratings of the Facing Forward Series Life After Cancer Treatment manual usability comprehension and satisfaction at 8 weeks and 6 months
PROJECTED ACCRUAL A total of 332 patients will be accrued for this study
Primary
Determine the efficacy of a psychoeducational intervention comprising a specific print intervention manual Facing Forward Series Life After Cancer Treatment Facing Forward manual and a general print intervention fact sheet The Cancer Information Service Questions and Answers vs the general print intervention fact sheet only on the uptake of recommended actions eg developing a wellness plan after treatment dealing with pain and fatigue finding support groups to deal with feelings after treatment and dealing with family issues after treatment in patients completing active treatment for stage I-IIIA breast prostate colorectal or thoracic cancer
Explore patient process evaluations of the Facing Forward manual in terms of its usability comprehension and satisfaction
Secondary
Examine psychological outcomes ie depressive symptoms fear of recurrence health-related quality of life and self-efficacy as a function of exposure to the Facing Forward manual
OUTLINE This is a multicenter randomized controlled open-label cohort study Patients are stratified according to participating center prior chemotherapy yes vs no and type of cancer breast vs colorectal vs prostate vs thoracic Patients are randomized to 1 of 2 arms
Arm I intervention Patients receive a specific print intervention manual entitled Facing Forward Series Life After Cancer Treatment and a general print intervention fact sheet entitled The Cancer Information Service Questions and Answers
Arm II control Patients receive the general print intervention fact sheet entitled The Cancer Information Service Questions and Answers
In both arms patients are evaluated at baseline within 18 days of the patients final cancer treatment visit 8 weeks via mailed home materials and then at 6 months via mailed home materials Baseline evaluations include background information ie demographics and medical status baseline use of educational materials survivorship activities and psychological factors ie depressive symptoms quality of life fear of recurrence and self-efficacy Psychological factors are also reassessed at 8 weeks and 6 months as well as use of educational materials and survivorship activities
For patients in both arms uptake of recommended actions are reassessed Patients in arm I complete ratings of the Facing Forward Series Life After Cancer Treatment manual usability comprehension and satisfaction at 8 weeks and 6 months
PROJECTED ACCRUAL A total of 332 patients will be accrued for this 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-803 | OTHER | FCCC IRB | None |
| CDR0000464245 | REGISTRY | None | None |
| NCI-2009-00569 | REGISTRY | None | None |