Breast CancerNCT00574145
Healing Touch in Treating Fatigue in Women Undergoing Radiation Therapy for Breast Cancer
A study testing Bio-field energy therapy, fatigue assessment and management and psychosocial assessment and care in people with Breast Cancer and Depression, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Depression, Fatigue
- What is being tested?
- Bio-field energy therapy, fatigue assessment and management and psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2007to Apr 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Examining the Effect of Healing Touch on Radiotherapy-induced Fatigue
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.
Read the 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.
- Conditions
- Breast Cancer, Depression, Fatigue
- Being tested
- Bio-field energy therapy, fatigue assessment and management, psychosocial assessment and care, quality-of-life assessment, therapeutic touch
- 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
- Medical subject headings
- Breast Neoplasms, Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-field energy therapyProcedure or surgery
Also called biofield therapy
Practitioner's hands to influence the human energy field surrounding the patient's body.
fatigue assessment and managementProcedure or surgery
duration
psychosocial assessment and careProcedure or surgery
duration
quality-of-life assessmentProcedure or surgery
duration
therapeutic touchProcedure or surgery
Practitioner's hands to influence the human energy field surrounding the patient's body
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Bio-field energy therapy; Procedure: fatigue assessment and management; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment; Procedure: therapeutic touch |
| 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 Receives: Procedure: fatigue assessment and management; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (2)
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
Measured: 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.
Measured: baseline and off-radiation at 5 to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startFeb 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Nancy Wells, Vanderbilt-Ingram Cancer Center
- Investigators
- Nancy Wells, DNSc, RN, Principal investigator, Vanderbilt-Ingram Cancer CenterFern Fitzhenry, PhD, RN, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574145
- Sponsor's protocol ID
- VICC SUPP 0633
- Other IDs
- VU-VICC-SUPP-0633
- Status last verified
- Aug 2012
- First submitted
- 14 Dec 2007
- Last updated
- 6 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 24105358
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Healing Touch on Radiotherapy-induced Fatigue
- ClinicalTrials.gov ID
- NCT00574145
- Acronym / sponsor ID
- VICC SUPP 0633
- Conditions
- Breast Cancer, Depression, Fatigue
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 17 Dec 2007 (estimated)
- Results
- Posted 6 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy/Supportive Care (A) | Experimental | Procedure: Bio-field energy therapy, Procedure: fatigue assessment and management, Procedure: psychosocial assessment and care, Procedure: quality-of-life assessment, Procedure: therapeutic touchPatients 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 | Procedure: fatigue assessment and management, Procedure: psychosocial assessment and care, Procedure: quality-of-life assessmentPatients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their therapy |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio-field energy therapyAlso: biofield therapyPractitioner's hands to influence the human energy field surrounding the patient's body. | Procedure or surgery | Radiotherapy/Supportive Care (A) |
| fatigue assessment and managementduration | Procedure or surgery | Control ARM (B), Radiotherapy/Supportive Care (A) |
| psychosocial assessment and careduration | Procedure or surgery | Control ARM (B), Radiotherapy/Supportive Care (A) |
| quality-of-life assessmentduration | Procedure or surgery | Control ARM (B), Radiotherapy/Supportive Care (A) |
| therapeutic touchPractitioner's hands to influence the human energy field surrounding the patient's body | Procedure or surgery | Radiotherapy/Supportive Care (A) |
Primary outcome
Fatigue Using the Brief Fatigue Inventory (BFI)
Time frame: 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.
2 secondary outcomes
Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B)
Time frame: baseline and 6 weeks
Intensity of Anxiety and Depression
Time frame: baseline and off-radiation at 5 to 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24105358FitzHenry 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Wells, DNSc, RN principal investigator
Vanderbilt-Ingram Cancer Center
Fern Fitzhenry, PhD, RN principal investigator
Vanderbilt-Ingram Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bio-field energy therapy, fatigue assessment and management and psychosocial assessment and care in people with Breast Cancer and Depression, run by Vanderbilt-Ingram Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Using the Brief Fatigue Inventory (BFI) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00574145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2012.