Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321880
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2006-05-02
Brief Title:
Healing Touch in Treating Patients Receiving Chemotherapy for Acute Myeloid Leukemia or Acute Lymphocytic Leukemia
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Healing Touch as a Supportive Intervention for Adult Acute Leukemia Patients A Pilot Study
Status:
COMPLETED
Status Verified Date:
2012-07
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 Supportive care such as healing touch may improve quality of life in patients receiving chemotherapy for acute leukemia
PURPOSE This clinical trial is studying how well healing touch works in treating patients receiving chemotherapy for acute myeloid leukemia or acute lymphocytic leukemia
PURPOSE This clinical trial is studying how well healing touch works in treating patients receiving chemotherapy for acute myeloid leukemia or acute lymphocytic leukemia
Detailed Description:
OBJECTIVES
Determine the feasibility of conducting a randomized controlled trial in terms of recruiting and retaining participants to a study of healing touch HT as supportive care in patients receiving chemotherapy for acute myeloid leukemia or acute lymphoblastic leukemia
Examine potential barriers to participation and ascertain reasons for study drop-outs in these patients
Demonstrate whether these patients will comply with treatment sessions and remain in the study
Obtain preliminary data on the effectiveness of HT on psychological distress and treatment-related symptoms focusing on fatigue and sleep disturbances in these patients
Determine if the HT protocol needs to be refined modified or eliminated based on pilot participant feedback for a randomized clinical trial
OUTLINE This is a pilot study
Within 1 week of admission to the hospital patients are interviewed by a research assistant about previous use of complementary or alternative medicine therapies knowledge of healing touch HT previous experience with HT willingness to participate in a study of HT for acute leukemia patients and willingness to be randomized in a HT study The first 12 patients interested in undergoing HT undergo a 30-minute session of HT therapy 3 times a week during weeks 2 3 and 4 of induction or reinduction chemotherapy Patients are also asked to rate current distress pain fatigue and nausea before and after the second HT session during weeks 2 3 and 4 Patients also complete self-report questionnaires at baseline during week 5 of induction or reinduction chemotherapy or prior to discharge from the hospital and during the first week of consolidation chemotherapy approximately week 9-13
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Determine the feasibility of conducting a randomized controlled trial in terms of recruiting and retaining participants to a study of healing touch HT as supportive care in patients receiving chemotherapy for acute myeloid leukemia or acute lymphoblastic leukemia
Examine potential barriers to participation and ascertain reasons for study drop-outs in these patients
Demonstrate whether these patients will comply with treatment sessions and remain in the study
Obtain preliminary data on the effectiveness of HT on psychological distress and treatment-related symptoms focusing on fatigue and sleep disturbances in these patients
Determine if the HT protocol needs to be refined modified or eliminated based on pilot participant feedback for a randomized clinical trial
OUTLINE This is a pilot study
Within 1 week of admission to the hospital patients are interviewed by a research assistant about previous use of complementary or alternative medicine therapies knowledge of healing touch HT previous experience with HT willingness to participate in a study of HT for acute leukemia patients and willingness to be randomized in a HT study The first 12 patients interested in undergoing HT undergo a 30-minute session of HT therapy 3 times a week during weeks 2 3 and 4 of induction or reinduction chemotherapy Patients are also asked to rate current distress pain fatigue and nausea before and after the second HT session during weeks 2 3 and 4 Patients also complete self-report questionnaires at baseline during week 5 of induction or reinduction chemotherapy or prior to discharge from the hospital and during the first week of consolidation chemotherapy approximately week 9-13
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CCCWFU-BG06-006 | None | None | None |
| CCCWFU-02305 | None | None | None |