Bone Marrow TransplantationNCT00843180
Massage for Pediatric Oncology
A study testing massage in people with Bone Marrow Transplantation and Distress, run by University of California, San Francisco at 1 site in United States.
Trial summary
Undergoing bone marrow transplantation (BMT) is associated with a high level of distress for patients and caregivers. Clinical research studies have reported benefits from massage for a) oncology patients, b) children, c) adults and children undergoing bone marrow transplants. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Bone Marrow Transplantation, Distress
- What is being tested?
- massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jan 2010
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being 5 to 18 years old
- Admitted for BMT.
- Rationale: This is a pediatric study for children up to age 18 admitted to the BMT unit. Questionnaires are not designed for children under age 5.
Who cannot join
- Parent or child unable to answer questionnaire due to language limitations.
- Rationale: The pilot character of the study with its limited budget does not include instruments in foreign languages, such as Chinese or Spanish. This could be a project for further studies.
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens' Hospital UCSF
San Francisco, California, 94143
About this study
Official title: Massage for Children Undergoing Bone Marrow Transplantation
Undergoing bone marrow transplantation (BMT) is associated with a high level of distress for patients and caregivers. Clinical research studies have reported benefits from massage for a) oncology patients, b) children, c) adults and children undergoing bone marrow transplants. A multi-center study of an intervention using a combination of massage therapy and a laugh cart to reduce distress in pediatric oncology patients undergoing BMT (PI: Phipps) is completed with results not yet published. There is still a need for independent studies to isolate the effect of massage for clinical outcomes (such as improved nausea and pain control) in children. Furthermore, this study will test the acceptability of an augmented massage intervention. In addition to provider-child massage, the augmented massage intervention includes training of the resident parent to provide additional parent-child massage, to relieve symptoms as needed. The goal of this augmented intervention is the improvement of symptom management in patients and decreased stress and feelings of helplessness in parents.
We propose a randomized pilot study at the UCSF pediatric bone marrow transplant center to assess the feasibility of a higher-quality study of the effects of massage in this population.
Read more
Aim 1: Determine the acceptability of a massage intervention for patients and parents on a pediatric bone marrow transplant unit.
Aim 2: Explore the logistics of implementing the augmented massage intervention at the bedside offered to consecutive patients over one year's time.
Aim 3: Collect preliminary data for patients and parents including patient clinical outcomes, quality of life, and satisfaction, and parental stress and mood to allow sample size calculations for further studies.
Read the detailed description
This study is a pilot randomized controlled feasibility trial of an augmented massage intervention, compared to a usual-care control group, in which intervention group participants will receive up to 3 massage sessions per week, during the 4-6 hospitalization at UCSF for Bone Marrow Transplant (BMT).
Participants will be approximately 24 children recruited from consecutive sample of pediatric cancer and non-cancer patients undergoing BMT age 5 to 18 admitted to UCSF children's hospital during one calendar year.
Intervention: Massage sessions will be gentle Swedish style combine with acupressure and will range from 20-45 minutes, provided by credentialed and trained massage therapists; augmentation will involve massage training for the resident parent, who rooms with the patient, to administer massage to his/her child during the course of the hospital stay. The control group will receive standard-care.
We will collect feasibility data and do exploratory comparison of clinical outcomes between groups.
Knowledge to be gained: We will have preliminary data for a larger trial that will determine whether an augmented massage intervention can support symptom management in the pediatric BMT unit.
- Hypothesis(es): Briefly explain the hypothesis(es) to be tested. If the study is not designed to test a hypothesis, simply state "None." Hypothesis 1a: >60% of Patients are willing to be randomized to the massage study.
Hypothesis 1b: 80% of patients randomized to massage will accept the massage intervention when offered.
Hypothesis 1c: The majority of parents (>60%) are willing to learn massage techniques for use on their children.
Hypothesis 2a: Professional massage providers will be able to deliver massage, negotiating schedule, space, time, and other patient-related medical activities and will be able to schedule >50% of planned massages.
Hypothesis 2b: Massage providers will be able to assess the acceptable time period for massage (between 10 minutes and 45 minutes).
Hypothesis 2c: Parents will carry out the massage on their children, will do at least 5 massages over the study period and are willing to provide a self-report of estimated time engaged in massage.
Hypothesis 3a: 80% of patients will answer survey questions about their experience in general and the massage intervention.
Hypothesis 3b: The RA will be able to collect clinical data from chart review and electronically stored lab data .
Hypothesis 3c: 80% of parents will answer survey questions about their experience in learning and delivering massage, stress, mood, PTSD symptoms and self-efficacy around patient management.
- Conditions
- Bone Marrow Transplantation, Distress
- Being tested
- massage
- Keywords
- Bone Marrow Transplant, Massage, Pediatric Oncology, children undergoing bone marrow transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageOther
one to three massages per week by massage practitioner additional massages by resident parent who is being taught to massage her/his child
| Study group | Role | What they receive |
|---|---|---|
| massage | Experimental | Not described Receives: Other: massage |
| control | No intervention | usual care only as control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days With Pain Scores >3 Measured on Numeric Rating Scale (Range 0-10; 0 for no Pain; 10 for Worst Pain Imaginable)
days of pain >3 by nurses notes based on pain scores on numeric rating scale (up to 28 days)
Measured: 7 days pre to 21 days post transplant = 28 days
Secondary outcomes (3)
Number of Vomiting Episodes
number of vomiting episodes as reported by nurses per occurence (no upper limit)
Measured: day -7 to +21 around transplant date
Days of Hospital Stay
days of hospital stay after bone marrow transplant (up to 100 days; participant observation was censored after 100 days)
Measured: days of hospital stay after bone marrow transplant
Days to Recovery Neutrophil Count
number of days to recovery neutrophil count >500 cells per microliter for 2 consecutive days (range, up to 100 days, censored at 100 days)
Measured: hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startNov 2008
- Primary completionJan 2010
- Study completionJan 2010
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.
- Other trials for Bone Marrow TransplantationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wolf E Mehling, MD, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843180
- Sponsor's protocol ID
- H41337-33343
- Status last verified
- May 2012
- First submitted
- 12 Feb 2009
- Last updated
- 8 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massage for Children Undergoing Bone Marrow Transplantation
- ClinicalTrials.gov ID
- NCT00843180
- Acronym / sponsor ID
- H41337-33343
- Conditions
- Bone Marrow Transplantation, Distress
- Keywords
- Bone Marrow Transplant, Massage, Pediatric Oncology, children undergoing bone marrow transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Feb 2009 (estimated)
- Results
- Posted 2 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Undergoing bone marrow transplantation (BMT) is associated with a high level of distress for patients and caregivers. Clinical research studies have reported benefits from massage for a) oncology patients, b) children, c) adults and children undergoing bone marrow transplants. A multi-center study of an intervention using a combination of massage therapy and a laugh cart to reduce distress in pediatric oncology patients undergoing BMT (PI: Phipps) is completed with results not yet published. There is still a need for independent studies to isolate the effect of massage for clinical outcomes (such as improved nausea and pain control) in children. Furthermore, this study will test the acceptability of an augmented massage intervention. In addition to provider-child massage, the augmented massage intervention includes training of the resident parent to provide additional parent-child massage, to relieve symptoms as needed. The goal of this augmented intervention is the improvement of symptom management in patients and decreased stress and feelings of helplessness in parents.
We propose a randomized pilot study at the UCSF pediatric bone marrow transplant center to assess the feasibility of a higher-quality study of the effects of massage in this population.
Aim 1: Determine the acceptability of a massage intervention for patients and parents on a pediatric bone marrow transplant unit.
Aim 2: Explore the logistics of implementing the augmented massage intervention at the bedside offered to consecutive patients over one year's time.
Aim 3: Collect preliminary data for patients and parents including patient clinical outcomes, quality of life, and satisfaction, and parental stress and mood to allow sample size calculations for further studies.
Detailed description
This study is a pilot randomized controlled feasibility trial of an augmented massage intervention, compared to a usual-care control group, in which intervention group participants will receive up to 3 massage sessions per week, during the 4-6 hospitalization at UCSF for Bone Marrow Transplant (BMT).
Participants will be approximately 24 children recruited from consecutive sample of pediatric cancer and non-cancer patients undergoing BMT age 5 to 18 admitted to UCSF children's hospital during one calendar year.
Intervention: Massage sessions will be gentle Swedish style combine with acupressure and will range from 20-45 minutes, provided by credentialed and trained massage therapists; augmentation will involve massage training for the resident parent, who rooms with the patient, to administer massage to his/her child during the course of the hospital stay. The control group will receive standard-care.
We will collect feasibility data and do exploratory comparison of clinical outcomes between groups.
Knowledge to be gained: We will have preliminary data for a larger trial that will determine whether an augmented massage intervention can support symptom management in the pediatric BMT unit.
- Hypothesis(es): Briefly explain the hypothesis(es) to be tested. If the study is not designed to test a hypothesis, simply state "None." Hypothesis 1a: >60% of Patients are willing to be randomized to the massage study.
Hypothesis 1b: 80% of patients randomized to massage will accept the massage intervention when offered.
Hypothesis 1c: The majority of parents (>60%) are willing to learn massage techniques for use on their children.
Hypothesis 2a: Professional massage providers will be able to deliver massage, negotiating schedule, space, time, and other patient-related medical activities and will be able to schedule >50% of planned massages.
Hypothesis 2b: Massage providers will be able to assess the acceptable time period for massage (between 10 minutes and 45 minutes).
Hypothesis 2c: Parents will carry out the massage on their children, will do at least 5 massages over the study period and are willing to provide a self-report of estimated time engaged in massage.
Hypothesis 3a: 80% of patients will answer survey questions about their experience in general and the massage intervention.
Hypothesis 3b: The RA will be able to collect clinical data from chart review and electronically stored lab data .
Hypothesis 3c: 80% of parents will answer survey questions about their experience in learning and delivering massage, stress, mood, PTSD symptoms and self-efficacy around patient management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| massage | Experimental | Other: massage |
| control | No intervention | –usual care only as control arm |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Being 5 to 18 years old
- Admitted for BMT.
- Rationale: This is a pediatric study for children up to age 18 admitted to the BMT unit. Questionnaires are not designed for children under age 5.
Key exclusion criteria (2 listed)
- Parent or child unable to answer questionnaire due to language limitations.
- Rationale: The pilot character of the study with its limited budget does not include instruments in foreign languages, such as Chinese or Spanish. This could be a project for further studies.
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 |
|---|---|---|
| massageone to three massages per week by massage practitioner additional massages by resident parent who is being taught to massage her/his child | Other | massage |
Primary outcome
Number of Days With Pain Scores >3 Measured on Numeric Rating Scale (Range 0-10; 0 for no Pain; 10 for Worst Pain Imaginable)
Time frame: 7 days pre to 21 days post transplant = 28 days
days of pain >3 by nurses notes based on pain scores on numeric rating scale (up to 28 days)
3 secondary outcomes
Number of Vomiting Episodes
Time frame: day -7 to +21 around transplant date
Days of Hospital Stay
Time frame: days of hospital stay after bone marrow transplant
Days to Recovery Neutrophil Count
Time frame: hospital stay
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Wolf E Mehling, MD study director
University of California, San Francisco
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 in people with Bone Marrow Transplantation and Distress, run by University of California, San Francisco 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 3 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 8 May 2012. 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?
Yes. Results are posted in the registry (first posted 2 May 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?
Number of Days With Pain Scores >3 Measured on Numeric Rating Scale (Range 0-10; 0 for no Pain; 10 for Worst Pain Imaginable) (time frame: 7 days pre to 21 days post transplant = 28 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 8 May 2012.