Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| VU-VICC-SUPP-0633 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Healing touch therapy may be effective in lessening fatigue in women with breast cancer who are undergoing radiation therapy.
PURPOSE: This randomized clinical trial is studying how well healing touch works in treating fatigue in women undergoing radiation therapy for breast cancer.
OBJECTIVES:
OUTLINE: Patients are stratified by type of treatment (radiotherapy alone vs chemotherapy completed prior to radiotherapy)
Patients complete the Hospital Anxiety and Depression Scale (HAD) and a demographic variables form (age, race/ethnicity, marital status, employment) at baseline. Patient fatigue is measured on a weekly basis throughout radiotherapy with completion of the Brief Fatigue Inventory (BFI). The Functional Assessment of Cancer Therapy-Breast form (FACT-B) is completed at baseline and the end of radiotherapy. Patients undergo a 20-minute interview at the end of study to determine the acceptability of the intervention.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy/Supportive Care (A) | Experimental | Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy |
|
| Control ARM (B) | Sham Comparator | Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio-field energy therapy | Procedure | Practitioner's hands to influence the human energy field surrounding the patient's body. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Using the Brief Fatigue Inventory (BFI) | 9-items with an 11-point rating scale measures intensity of fatigue (3 items, 0 = no fatigue to 10 = fatigue as bad as you can imagine) and interference of fatigue on daily life (6 items, 0 = does not interfere to 10 = completely interferes. Each participant's score is summed with a possible minimum score of 0 and a possible maximum score of 90. A mean score was then determined. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B) | 36 items that measure general quality of life (27 items) and specific breast cancer concerns (9 items) on a 5-point rating scale with 0 = not at all to 4 = very much. Minimum (worst quality of life) possible score = 0 and maximum (best quality of life) possible score = 144. Physical and emotional well-being scores were reverse coded and sub scale scores were summed. Median scores for baseline and at 6 weeks were determined |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nancy Wells, DNSc, RN | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Fern Fitzhenry, PhD, RN | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville | Tennessee | 37064 | United States | ||
| Vanderbilt-Ingram Cancer Center at Franklin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24105358 | Derived | FitzHenry F, Wells N, Slater V, Dietrich MS, Wisawatapnimit P, Chakravarthy AB. A randomized placebo-controlled pilot study of the impact of healing touch on fatigue in breast cancer patients undergoing radiation therapy. Integr Cancer Ther. 2014 Mar;13(2):105-13. doi: 10.1177/1534735413503545. Epub 2013 Oct 7. |
Not provided
Not provided
Forty-four patients signed consent, all were eligible.
This study enrolled February 2007 to March 2009.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Control ARM (B) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| fatigue assessment and management | Procedure | duration |
|
| psychosocial assessment and care | Procedure | duration |
|
| quality-of-life assessment | Procedure | duration |
|
| therapeutic touch | Procedure | Practitioner's hands to influence the human energy field surrounding the patient's body |
|
| baseline and 6 weeks |
| Intensity of Anxiety and Depression | Measured on the Hospital Anxiety and Depression Scale, 14 items on a 4-point scale scored from 0 = not at all (best feeling) to 3 = very often (worst feeling). Scores are summed and range from a minimum of 0 (no anxiety or depression) to 42 (worst anxiety or depression)and a median for each arm is determined at the specified timepoints. | baseline and off-radiation at 5 to 7 weeks |
| Nashville |
| Tennessee |
| 37064 |
| United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fatigue Using the Brief Fatigue Inventory (BFI) | 9-items with an 11-point rating scale measures intensity of fatigue (3 items, 0 = no fatigue to 10 = fatigue as bad as you can imagine) and interference of fatigue on daily life (6 items, 0 = does not interfere to 10 = completely interferes. Each participant's score is summed with a possible minimum score of 0 and a possible maximum score of 90. A mean score was then determined. | Patients who completed 5 of 8 maximum collection points. Arm A: 1 patient withdrew at 2 days, 1 patient withdrew at 5 days. Arm B: 1 patient withdrew at 4 weeks | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B) | 36 items that measure general quality of life (27 items) and specific breast cancer concerns (9 items) on a 5-point rating scale with 0 = not at all to 4 = very much. Minimum (worst quality of life) possible score = 0 and maximum (best quality of life) possible score = 144. Physical and emotional well-being scores were reverse coded and sub scale scores were summed. Median scores for baseline and at 6 weeks were determined | Arm A:1 patient was accidentally notified of group assignment before final data collected, 2 patients withdrew (1 at 2 days), 1 at 5 days. )Arm B: 1 patient withdrew at 4 weeks | Posted | Median | Full Range | units on a scale | baseline and 6 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Intensity of Anxiety and Depression | Measured on the Hospital Anxiety and Depression Scale, 14 items on a 4-point scale scored from 0 = not at all (best feeling) to 3 = very often (worst feeling). Scores are summed and range from a minimum of 0 (no anxiety or depression) to 42 (worst anxiety or depression)and a median for each arm is determined at the specified timepoints. | Arm A: 1 patient withdrew at 2 days, 1 patient withdrew at 5 days. Arm B: 1 patient withdrew at 4 weeks | Posted | Median | Full Range | units on a scale | baseline and off-radiation at 5 to 7 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 22 | 0 | 22 | ||
| EG001 | 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 | 0 | 22 | 0 | 22 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Wells, DNSc., R.N | Vanderbilt-Ingram Cancer Center | 615-322-6184 | nancy.wells@vanderbilt.edu |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003863 | Depression |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D000067250 | Psychiatric Rehabilitation |
| D019124 | Therapeutic Touch |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D026443 | Spiritual Therapies |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Participants |
|
|
|