Breast Cancer, Depression, Fatigue
Conditions
Keywords
fatigue, depression, psychosocial effects of cancer and its treatment, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, recurrent breast cancer
Brief summary
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.
Detailed description
OBJECTIVES: * To determine the ability to recruit and retain patients with breast cancer receiving curative radiotherapy in a Complementary and Alternative Medicine trial. * To determine the acceptability of weekly healing touch therapy to patients with breast cancer who receive curative radiotherapy. * To examine the effect of healing touch on fatigue and quality of life for patients with breast cancer receiving radiotherapy as a component of therapy. OUTLINE: Patients are stratified by type of treatment (radiotherapy alone vs chemotherapy completed prior to radiotherapy) * Arm I:Patients receive healing-touch therapy administered once a week for 45 minutes by a healing-touch therapist for the duration of radiotherapy. * Arm II: Patients receive sham-therapy administered once a week for 45 minutes by a sham-practitioner (NOT a healing-touch therapist) for the duration of 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.
Interventions
PROCEDUREBio-field energy therapy
Practitioner's hands to influence the human energy field surrounding the patient's body.
PROCEDUREfatigue assessment and management
duration
PROCEDUREpsychosocial assessment and care
duration
PROCEDUREquality-of-life assessment
duration
PROCEDUREtherapeutic touch
Practitioner's hands to influence the human energy field surrounding the patient's body
Sponsors
National Cancer Institute (NCI)
Vanderbilt-Ingram Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically proven breast cancer * Receiving post lumpectomy or post mastectomy radiation therapy (RT) * Eastern Cooperative Oncology Group performance status of 0, 1 or 2 * Prescribed a minimum of 5 weeks of RT * Between the ages of 21 and 75 * Able to speak English. * Provides written informed consent
Exclusion criteria
* Documented active psychiatric illness * Documented cognitive impairment that would preclude the ability to provide informed consent. * Stage IV breast cancer * Receiving concurrent chemotherapy and RT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Using the Brief Fatigue Inventory (BFI) | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B) | baseline and 6 weeks | 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 |
| Intensity of Anxiety and Depression | baseline and off-radiation at 5 to 7 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
This study enrolled February 2007 to March 2009.
Pre-assignment details
Forty-four patients signed consent, all were eligible.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 22 |
| 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 | 22 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Control ARM (B) | Radiotherapy/Supportive Care (A) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 21 Participants | 42 Participants |
| Age Continuous | 51 years STANDARD_DEVIATION 1 | 50 years STANDARD_DEVIATION 1 | 51 years STANDARD_DEVIATION 1 |
| Region of Enrollment United States | 22 participants | 22 participants | 44 participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 44 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
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.
Time frame: 6 weeks
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiotherapy/Supportive Care (A) | Fatigue Using the Brief Fatigue Inventory (BFI) | 2.786 units on a scale | Standard Deviation 0.1963 |
| Control ARM (B) | Fatigue Using the Brief Fatigue Inventory (BFI) | 1.356 units on a scale | Standard Deviation 0.1413 |
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.
Time frame: baseline and off-radiation at 5 to 7 weeks
Population: Arm A: 1 patient withdrew at 2 days, 1 patient withdrew at 5 days. Arm B: 1 patient withdrew at 4 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Radiotherapy/Supportive Care (A) | Intensity of Anxiety and Depression | Baseline | 21 units on a scale |
| Radiotherapy/Supportive Care (A) | Intensity of Anxiety and Depression | At 5 to 7 weeks | 28 units on a scale |
| Control ARM (B) | Intensity of Anxiety and Depression | Baseline | 23 units on a scale |
| Control ARM (B) | Intensity of Anxiety and Depression | At 5 to 7 weeks | 28 units on a scale |
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
Time frame: baseline and 6 weeks
Population: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Radiotherapy/Supportive Care (A) | Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B) | Baseline | 61 units on a scale |
| Radiotherapy/Supportive Care (A) | Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B) | 6 Weeks | 65 units on a scale |
| Control ARM (B) | Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B) | Baseline | 65 units on a scale |
| Control ARM (B) | Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B) | 6 Weeks | 67 units on a scale |