Healing Touch in Treating Fatigue in Women Undergoing Radiation Therapy for Breast Cancer
This study has been completed.
Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborator:
Information provided by (Responsible Party):
Nancy Wells, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00574145
First received: December 14, 2007
Last updated: August 4, 2012
Last verified: August 2012
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Results First Received: March 15, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Supportive Care |
| Conditions: |
Breast Cancer Depression Fatigue |
| Interventions: |
Procedure: Bio-field energy therapy Procedure: fatigue assessment and management Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: therapeutic touch |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| This study enrolled February 2007 to March 2009. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Forty-four patients signed consent, all were eligible. |
Reporting Groups
| Description | |
|---|---|
| Radiotherapy/Supportive Care (A) | Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy |
| Control ARM (B) | Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy |
Participant Flow: Overall Study
| Radiotherapy/Supportive Care (A) | Control ARM (B) | |
|---|---|---|
| STARTED | 22 | 22 |
| COMPLETED | 20 | 21 |
| NOT COMPLETED | 2 | 1 |
| Withdrawal by Subject | 2 | 1 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Radiotherapy/Supportive Care (A) | Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy |
| Control ARM (B) | Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy |
| Total | Total of all reporting groups |
Baseline Measures
| Radiotherapy/Supportive Care (A) | Control ARM (B) | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
22 | 22 | 44 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 21 | 42 |
| >=65 years | 1 | 1 | 2 |
|
Age
[units: years] Mean ± Standard Deviation |
50 ± 1 | 51 ± 1 | 51 ± 1 |
|
Gender
[units: participants] |
|||
| Female | 22 | 22 | 44 |
| Male | 0 | 0 | 0 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 22 | 22 | 44 |
Outcome Measures
| 1. Primary: | Fatigue Using the Brief Fatigue Inventory (BFI) [ Time Frame: 6 weeks ] |
| 2. Secondary: | Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B) [ Time Frame: baseline and 6 weeks ] |
| 3. Secondary: | Intensity of Anxiety and Depression [ Time Frame: baseline and off-radiation at 5 to 7 weeks ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Nancy Wells, DNSc., R.N
Organization: Vanderbilt-Ingram Cancer Center
phone: 615-322-6184
e-mail: nancy.wells@vanderbilt.edu
Organization: Vanderbilt-Ingram Cancer Center
phone: 615-322-6184
e-mail: nancy.wells@vanderbilt.edu
No publications provided
| Responsible Party: | Nancy Wells, Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00574145 History of Changes |
| Other Study ID Numbers: | VICC SUPP 0633, VU-VICC-SUPP-0633 |
| Study First Received: | December 14, 2007 |
| Results First Received: | March 15, 2012 |
| Last Updated: | August 4, 2012 |
| Health Authority: | United States: Federal Government |