Bone MarrowNCT00760227
Testing the Effectiveness of Child and Parent-Targeted Health Promotion Interventions in Pediatric Stem Cell Transplantation
A study testing Massage Therapy, Humor Therapy and Relaxation Therapy in people with Bone Marrow and Stem Cell Transplant, run by St. Jude Children's Research Hospital at 4 sites in 2 countries.
Trial summary
The overall aim of the proposed project is to evaluate the impact of a health promotion intervention for children undergoing bone marrow or stem cell transplant (BMT). The intervention is complementary in nature, designed to increase the experience of positive affect and reduce somatic distress and mood disturbance… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Bone Marrow, Stem Cell Transplant
- What is being tested?
- Massage Therapy, Humor Therapy and Relaxation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2003to Dec 2007
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- For Child Participants:
- Age 6-18 years inclusive.
- Scheduled to undergo allogeneic or autologous stem cell transplant.
- Anticipated hospital stay of at least 3 weeks.
- English speaking
- For Resident Parent Participants:
Show all 9Show fewer
- Parent speaks and reads English.
- Parent will be a primary caregiver for child during BMT.
- Parent will be available for the duration of transplant hospitalization.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Columbus Children's Research Institute
Columbus, Ohio
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
The overall aim of the proposed project is to evaluate the impact of a health promotion intervention for children undergoing bone marrow or stem cell transplant (BMT). The intervention is complementary in nature, designed to increase the experience of positive affect and reduce somatic distress and mood disturbance, that is, to improve overall child well-being. The study will utilize a positive psychology model, exploring the hypothesis that improved outcomes will be mediated by the increased experience of positive affect states brought about by the intervention. The primary focus is on a child-targeted intervention that includes massage therapy and humor therapy. The study will also assess whether the addition of a similar parent-targeted intervention involving massage therapy and relaxation training will provide significant benefits beyond those provided by the child-targeted intervention alone. The study will utilize a 3-group design, with participants randomized to receive:1) a child-targeted intervention (HPI-C); 2) a child targeted intervention plus a parent-targeted intervention (HPI-CP); 3) standard care (SC). Primary outcomes include child positive affect, somatic distress and mood disturbance, as well as measures of parental positive affect and distress. Additional objectives of the study include examining the impact of the intervention on short-term medical outcomes, as well as measures of child health-related quality of life and parent and child post-traumatic stress symptoms (PTSS) at 6 months post-BMT. Analyses will explore hypotheses specific to the positive psychology model, testing the role of positive affect and dispositional optimism as mediators and moderators of the intervention on child and parent well-being. We will also obtain pilot data examining the effect of the interventions on neuroendocrine and neuroimmune markers of stress.
Read the detailed description
Treatment Plan: Interventions involve 3 components, Massage Therapy, Humor Therapy, and Relaxation Therapy, as described below:
Massage Therapy Patient and parents will meet with a licensed massage therapist at the time of admission. During the session, the therapist will introduce them to the rationale of the massage intervention before moving on to provide the initial massage session. Each session will last approximately 1/2 hour. Massage sessions will be scheduled 3x/week from admission through week +3.
Humor Therapy For this component will utilize a humor cart, stocked with humorous video shorts, books, gags, props and games.
Relaxation Therapy In the initial session held near the time of admission, parents will meet with the RA therapist, who will describe relaxation response and the benefits of a regular practice of relaxation techniques. They will be led through a modified progressive muscle relaxation induction, using breath awareness and muscle release, followed by guided imagery.
- Conditions
- Bone Marrow, Stem Cell Transplant
- Being tested
- Massage Therapy, Humor Therapy, Relaxation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage TherapyOther
Patient and parents will meet with a licensed massage therapist at the time of admission. During the session, the therapist will introduce them to the rationale of the massage intervention before moving on to provide the initial massage session. Each session will last approximately 1/2 hour. Massage sessions will be scheduled 3x/week from admission through week +3.
Humor TherapyOther
For this component will will utilize a humor cart, stocked with humorous video shorts, books, gags, props and games.
Relaxation TherapyOther
In the initial session held near the time of admission, parents will meet with the RA therapist, who will describe relaxation response and the benefits of a regular practice of relaxation techniques. They will be led through a modified progressive muscle relaxation induction, using breath awareness and muscle release, followed by guided imagery.
| Study group | Role | What they receive |
|---|---|---|
| 1: HPI-C | Other | Child Intervention Only Group Receives: Other: Massage Therapy; Other: Humor Therapy |
| 2: HPI-CP | Other | Parent and Child Intervention Group Receives: Other: Massage Therapy; Other: Relaxation Therapy |
| 3: SC | No intervention | Standard Care Control Group- No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the effectiveness of the health-promotion interventions in improving patient and parent well-being during the acute phase of BMT.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startJan 2003
- Primary completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MarrowStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean Phipps, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760227
- Sponsor's protocol ID
- HOBIT3
- Status last verified
- Sep 2011
- First submitted
- 25 Sep 2008
- Last updated
- 29 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of Child and Parent-Targeted Health Promotion Interventions in Pediatric Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00760227
- Acronym / sponsor ID
- HOBIT3
- Conditions
- Bone Marrow, Stem Cell Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Dec 2007 (actual)
- First posted
- 26 Sep 2008 (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.
The overall aim of the proposed project is to evaluate the impact of a health promotion intervention for children undergoing bone marrow or stem cell transplant (BMT). The intervention is complementary in nature, designed to increase the experience of positive affect and reduce somatic distress and mood disturbance, that is, to improve overall child well-being. The study will utilize a positive psychology model, exploring the hypothesis that improved outcomes will be mediated by the increased experience of positive affect states brought about by the intervention. The primary focus is on a child-targeted intervention that includes massage therapy and humor therapy. The study will also assess whether the addition of a similar parent-targeted intervention involving massage therapy and relaxation training will provide significant benefits beyond those provided by the child-targeted intervention alone. The study will utilize a 3-group design, with participants randomized to receive:1) a child-targeted intervention (HPI-C); 2) a child targeted intervention plus a parent-targeted intervention (HPI-CP); 3) standard care (SC). Primary outcomes include child positive affect, somatic distress and mood disturbance, as well as measures of parental positive affect and distress. Additional objectives of the study include examining the impact of the intervention on short-term medical outcomes, as well as measures of child health-related quality of life and parent and child post-traumatic stress symptoms (PTSS) at 6 months post-BMT. Analyses will explore hypotheses specific to the positive psychology model, testing the role of positive affect and dispositional optimism as mediators and moderators of the intervention on child and parent well-being. We will also obtain pilot data examining the effect of the interventions on neuroendocrine and neuroimmune markers of stress.
Detailed description
Treatment Plan: Interventions involve 3 components, Massage Therapy, Humor Therapy, and Relaxation Therapy, as described below:
Massage Therapy Patient and parents will meet with a licensed massage therapist at the time of admission. During the session, the therapist will introduce them to the rationale of the massage intervention before moving on to provide the initial massage session. Each session will last approximately 1/2 hour. Massage sessions will be scheduled 3x/week from admission through week +3.
Humor Therapy For this component will utilize a humor cart, stocked with humorous video shorts, books, gags, props and games.
Relaxation Therapy In the initial session held near the time of admission, parents will meet with the RA therapist, who will describe relaxation response and the benefits of a regular practice of relaxation techniques. They will be led through a modified progressive muscle relaxation induction, using breath awareness and muscle release, followed by guided imagery.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1: HPI-C | Other | Other: Massage Therapy, Other: Humor TherapyChild Intervention Only Group |
| 2: HPI-CP | Other | Other: Massage Therapy, Other: Relaxation TherapyParent and Child Intervention Group |
| 3: SC | No intervention | –Standard Care Control Group- No Intervention |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age 6-18 years inclusive.
- Scheduled to undergo allogeneic or autologous stem cell transplant.
- Anticipated hospital stay of at least 3 weeks.
- English speaking
- Parent speaks and reads English.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Massage TherapyPatient and parents will meet with a licensed massage therapist at the time of admission. During the session, the therapist will introduce them to the rationale of the massage intervention before moving on to provide the initial massage session. Each session will last approximately 1/2 hour. Massage sessions will be scheduled 3x/week from admission through week +3. | Other | 1: HPI-C, 2: HPI-CP |
| Humor TherapyFor this component will will utilize a humor cart, stocked with humorous video shorts, books, gags, props and games. | Other | 1: HPI-C |
| Relaxation TherapyIn the initial session held near the time of admission, parents will meet with the RA therapist, who will describe relaxation response and the benefits of a regular practice of relaxation techniques. They will be led through a modified progressive muscle relaxation induction, using breath awareness and muscle release, followed by guided imagery. | Other | 2: HPI-CP |
Primary outcome
To test the effectiveness of the health-promotion interventions in improving patient and parent well-being during the acute phase of BMT.
Time frame: 6 weeks
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 29 Sep 2011.
- St. Jude Children's Research HospitalLink provided by the sponsor.
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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.
Sean Phipps, PhD principal investigator
St. Jude Children's Research Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage Therapy, Humor Therapy and Relaxation Therapy in people with Bone Marrow and Stem Cell Transplant, run by St. Jude Children's Research Hospital at 4 sites in 2 countries.
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 9 inclusion and 0 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 29 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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?
To test the effectiveness of the health-promotion interventions in improving patient and parent well-being during the acute phase of BMT. (time frame: 6 weeks). 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 29 Sep 2011; AzTrials last refreshed its copy on 7 Nov 2026.