Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057733
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2003-04-07
Brief Title:
Stress Management Training in Patients Undergoing Radiation Therapy for Cancer
Sponsor:
University of South Florida
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Stress Management Training For Patients Undergoing Radiotherapy
Status:
COMPLETED
Status Verified Date:
2005-04
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 Stress management techniques such as muscle relaxation guided imagery and abdominal breathing may improve quality of life and decrease emotional distress in patients who are undergoing radiation therapy for cancer
PURPOSE Randomized clinical trial to determine the effectiveness of stress management training in helping cancer patients cope with the emotional distress of radiation therapy
PURPOSE Randomized clinical trial to determine the effectiveness of stress management training in helping cancer patients cope with the emotional distress of radiation therapy
Detailed Description:
OBJECTIVES
Primary
Determine whether a modified version of a self-administered stress management training intervention previously found to be of benefit in chemotherapy patients is effective in improving quality of life and decreasing psychological distress anxiety and depression in patients with cancer who are undergoing radiotherapy
Secondary
Compare the efficacy of this intervention on improving quality of life and decreasing psychological distress anxiety and depression in male vs female patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive self-administered stress management training SSMT in 3 stress management techniques progressive muscle relaxation training and guided imagery abdominal breathing and coping skills adapted specifically for use during radiotherapy Patients initially receive a 5-minute standardized presentation regarding the nature and purpose of SSMT Patients then receive information and instruction regarding the three stress management techniques comprising a videotape audiotape and brochure Patients also receive their institutions usual psychosocial care
Arm II Patients receive their institutions usual psychosocial care only Quality of life anxiety and depression are assessed at baseline and then at 1 2 and 3 weeks Intervention helpfulness is assessed at 3 weeks
PROJECTED ACCRUAL A total of 327 patients approximately 163 per treatment arm will be accrued for this study within 2 years
Primary
Determine whether a modified version of a self-administered stress management training intervention previously found to be of benefit in chemotherapy patients is effective in improving quality of life and decreasing psychological distress anxiety and depression in patients with cancer who are undergoing radiotherapy
Secondary
Compare the efficacy of this intervention on improving quality of life and decreasing psychological distress anxiety and depression in male vs female patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive self-administered stress management training SSMT in 3 stress management techniques progressive muscle relaxation training and guided imagery abdominal breathing and coping skills adapted specifically for use during radiotherapy Patients initially receive a 5-minute standardized presentation regarding the nature and purpose of SSMT Patients then receive information and instruction regarding the three stress management techniques comprising a videotape audiotape and brochure Patients also receive their institutions usual psychosocial care
Arm II Patients receive their institutions usual psychosocial care only Quality of life anxiety and depression are assessed at baseline and then at 1 2 and 3 weeks Intervention helpfulness is assessed at 3 weeks
PROJECTED ACCRUAL A total of 327 patients approximately 163 per treatment arm will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TAGH-20291 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069466 | REGISTRY | None | None |
| NCI-5721 | None | None | None |
| NCI-P02-0227 | None | None | None |