Breast CancerNCT01736605
The Effect of Meditation and Massage Therapy for Breast Cancer Patients Undergoing Tissue Reconstruction
A study testing Massage and Massage combined with meditation in people with Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
In this study we propose to explore the efficacy of massage therapy combined with meditation in women recovering from tissue reconstruction after mastectomy for breast cancer. Patients will be randomized into 2 groups. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Massage and Massage combined with meditation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women age 18 and above able to give informed consent
- Women who are undergoing mastectomies for breast cancer and the following autologous tissue reconstruction.
- Free TRAM flaps (TRAM = Transverse Rectus Abdominis Myocutaneous)
- Muscle-sparing (MS) free TRAM flaps (or MS-TRAM)
- DIEP flaps (DIEP = Deep Inferior Epigastric Perforator)
- SIEA flaps (SIEA = Superficial Inferior Epigastric Artery)
Show all 10Show fewer
- Pedicled TRAM flaps
- Patients who undergo one of these 5 surgeries on a Monday or a Tuesday
- Able to speak and understand English
- Able to complete the three questionnaires
Who cannot join
- Women who decline to participate in the study
- Women with any kind of breast reconstruction surgery other than what is listed in the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Meditation and Massage Therapy for Breast Cancer Patients Undergoing Autologous Tissue Reconstruction - A Pilot Study
In this study we propose to explore the efficacy of massage therapy combined with meditation in women recovering from tissue reconstruction after mastectomy for breast cancer. Patients will be randomized into 2 groups. The first group will consist of massage therapy on 3 consecutive days starting on the 1st day after surgery. The second group will consist of massage therapy combined with meditation for 3 consecutive days starting on the 1st day after surgery. The effect of massage and massage combined with meditation on stress, anxiety, relaxation, insomnia, alertness, fatigue, tension/muscular discomfort, pain, mood and energy level will be evaluated by using three different surveys.
Read the detailed description
Besides skin cancer breast cancer is the most common malignancy among women. Most women with breast cancer will undergo some kind of breast cancer surgery. For women undergoing a mastectomy, breast reconstruction offers significant quality of life benefits and is a vital option to enhance breast cancer recovery. There are two general types of reconstructive options:
- Prosthetic devices (saline implants, silicone implants, tissue expanders)
- Autologous tissue reconstructions with tissue flaps that are transferred from adjoining or distant donor sites to the anterior chest wall.
When reconstruction of the breast mound is accomplished using the patient's own tissues, the result is typically more natural in both appearance and feel than with expander/implant reconstruction. However the disadvantages of autologous reconstruction include longer surgical procedures and prolonged recovery time as compared to prosthetic reconstruction. Postoperative pain, anxiety, fatigue are among the challenges facing patients undergoing breast cancer surgery and especially patients who decided to undergo these complicated plastic surgical procedures. Massage therapy has been used successfully to target common postoperative symptoms such as pain, anxiety, tension and fatigue in breast cancer patients.
Meditation has been shown to be helpful in achieving healing and relaxation through purposeful contemplation and reflection.
In this study we propose to explore the effectiveness of massage therapy combined with meditation in breast cancer patients recovering from autologous tissue reconstruction with the hope that the combination will augment the benefit obtained by massage therapy alone.
- Conditions
- Breast Cancer
- Being tested
- Massage, Massage combined with meditation
- Keywords
- Massage, Meditation, Breast Cancer, Breast Surgery, Breast Reconstruction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageProcedure or surgery
Patients will receive a daily 20 minute massage in their hospital room on the first 3 days following surgery.
Massage combined with meditationProcedure or surgery
Also called Massage, Meditation
Patients will receive a daily 20 minute massage combined with meditation in their hospital room on the first 3 days following surgery.
| Study group | Role | What they receive |
|---|---|---|
| Massage | Active comparator | Daily massage for 20 minutes the first 3 days following surgery. Receives: Procedure: Massage |
| Massage combined with meditation | Active comparator | Daily massage for 20 minutes combined with meditation the first 3 days following surgery. Receives: Procedure: Massage combined with meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the effect of massage therapy on pain and stress related symptoms after breast reconstruction surgery compared to baseline.
Measured: 3 Days
Secondary outcomes (1)
Assess the effect of massage therapy combined with meditation on pain and stress related symptoms after breast reconstruction surgery compared to baseline.
Measured: 3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dietlind Wahner-Roedler, Mayo Clinic
- Investigators
- Dietlind L. Wahner-Roedler, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736605
- Sponsor's protocol ID
- 12-008563
- Status last verified
- Apr 2015
- First submitted
- 20 Nov 2012
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Meditation and Massage Therapy for Breast Cancer Patients Undergoing Autologous Tissue Reconstruction - A Pilot Study
- ClinicalTrials.gov ID
- NCT01736605
- Acronym / sponsor ID
- 12-008563
- Conditions
- Breast Cancer
- Keywords
- Massage, Meditation, Breast Cancer, Breast Surgery, Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study we propose to explore the efficacy of massage therapy combined with meditation in women recovering from tissue reconstruction after mastectomy for breast cancer. Patients will be randomized into 2 groups. The first group will consist of massage therapy on 3 consecutive days starting on the 1st day after surgery. The second group will consist of massage therapy combined with meditation for 3 consecutive days starting on the 1st day after surgery. The effect of massage and massage combined with meditation on stress, anxiety, relaxation, insomnia, alertness, fatigue, tension/muscular discomfort, pain, mood and energy level will be evaluated by using three different surveys.
Detailed description
Besides skin cancer breast cancer is the most common malignancy among women. Most women with breast cancer will undergo some kind of breast cancer surgery. For women undergoing a mastectomy, breast reconstruction offers significant quality of life benefits and is a vital option to enhance breast cancer recovery. There are two general types of reconstructive options:
- Prosthetic devices (saline implants, silicone implants, tissue expanders)
- Autologous tissue reconstructions with tissue flaps that are transferred from adjoining or distant donor sites to the anterior chest wall.
When reconstruction of the breast mound is accomplished using the patient's own tissues, the result is typically more natural in both appearance and feel than with expander/implant reconstruction. However the disadvantages of autologous reconstruction include longer surgical procedures and prolonged recovery time as compared to prosthetic reconstruction. Postoperative pain, anxiety, fatigue are among the challenges facing patients undergoing breast cancer surgery and especially patients who decided to undergo these complicated plastic surgical procedures. Massage therapy has been used successfully to target common postoperative symptoms such as pain, anxiety, tension and fatigue in breast cancer patients.
Meditation has been shown to be helpful in achieving healing and relaxation through purposeful contemplation and reflection.
In this study we propose to explore the effectiveness of massage therapy combined with meditation in breast cancer patients recovering from autologous tissue reconstruction with the hope that the combination will augment the benefit obtained by massage therapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage | Active comparator | Procedure: MassageDaily massage for 20 minutes the first 3 days following surgery. |
| Massage combined with meditation | Active comparator | Procedure: Massage combined with meditationDaily massage for 20 minutes combined with meditation the first 3 days following surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women age 18 and above able to give informed consent
- Women who are undergoing mastectomies for breast cancer and the following autologous tissue reconstruction.
- Patients who undergo one of these 5 surgeries on a Monday or a Tuesday
- Able to speak and understand English
- Able to complete the three questionnaires
Key exclusion criteria (2 listed)
- Women who decline to participate in the study
- Women with any kind of breast reconstruction surgery other than what is listed in the inclusion criteria
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 |
|---|---|---|
| MassagePatients will receive a daily 20 minute massage in their hospital room on the first 3 days following surgery. | Procedure or surgery | Massage |
| Massage combined with meditationAlso: Massage, MeditationPatients will receive a daily 20 minute massage combined with meditation in their hospital room on the first 3 days following surgery. | Procedure or surgery | Massage combined with meditation |
Primary outcome
Assess the effect of massage therapy on pain and stress related symptoms after breast reconstruction surgery compared to baseline.
Time frame: 3 Days
1 secondary outcome
Assess the effect of massage therapy combined with meditation on pain and stress related symptoms after breast reconstruction surgery compared to baseline.
Time frame: 3 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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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.
Dietlind L. Wahner-Roedler, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage and Massage combined with meditation in people with Breast Cancer, run by Mayo Clinic at 1 site 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 10 inclusion and 2 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 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess the effect of massage therapy on pain and stress related symptoms after breast reconstruction surgery compared to baseline. (time frame: 3 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2015.