Health Status UnknownNCT00922285
Art Therapy for Caregivers of Young Patients Undergoing Bone Marrow Transplant for Cancer
A study testing psychosocial support for caregiver, questionnaire administration and quality-of-life assessment in people with Health Status Unknown and Psychosocial Effects of Cancer and Its Treatment, run by City of Hope Medical Center at 1 site in United States.
Trial summary
RATIONALE: Art therapy may help relieve emotional distress in caregivers of young patients undergoing bone marrow transplant for cancer. PURPOSE: This clinical trial is studying art therapy for caregivers of young patients undergoing bone marrow transplant for cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Status Unknown, Psychosocial Effects of Cancer and Its Treatment
- What is being tested?
- psychosocial support for caregiver, questionnaire administration and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jan 2010
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Family caregiver identified by the patient's physician as most involved in the patient care including, but not limited to, the following:
- Mother
- Father
- Grandmother
- Grandfather
- Aunt
- Uncle
- Older sibling
- One caregiver per pediatric patient
- No caregivers who are part of an institutional system and are temporarily fulfilling the custodial role of the patient (i.e., foster parents)
PATIENT CHARACTERISTICS:
- Able to speak and read English and/or Spanish
- No uncontrolled mental health and/or physical condition
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
About this study
Official title: Art Therapy Interventions With Caregivers Supporting Pediatric Patients Who Are Undergoing Bone Marrow Transplantation for Cancer
RATIONALE: Art therapy may help relieve emotional distress in caregivers of young patients undergoing bone marrow transplant for cancer.
PURPOSE: This clinical trial is studying art therapy for caregivers of young patients undergoing bone marrow transplant for cancer.
Read the detailed description
OBJECTIVES:
- Test the effects of an art therapy intervention on emotional distress in caregivers of pediatric patients undergoing bone marrow transplantation for cancer.
- Describe pro-social interactions of caregivers of pediatric patients undergoing bone marrow transplantation for cancer.
- Describe the illness experience of caregivers and how it is impacted by the art therapy intervention.
- Describe the caregivers' current health-related quality of life and life meaning prior to pediatric patients initiation of bone marrow transplantation for cancer.
- Determine the effect size for calculating the sample needed for a randomized clinical trial.
OUTLINE: Caregivers undergo art therapy over 60 minutes once a week for 6 weeks. Each session comprises developing trust through the expression of support, affirmation, and collaboration; creating intimacy through attunement; exploring affective states; integrative processing through the creation of an autobiographical narrative; and identifying opportunities for continued exploration and resources that support the client, should that exploration become necessary.
Caregivers also complete a Meaning of Life Questionnaire and a Family Quality of Life Scale at baseline and at the end of week 6.
- Being tested
- psychosocial support for caregiver, questionnaire administration, quality-of-life assessment, stress management therapy
- Keywords
- psychosocial effects of cancer and its treatment, health status unknown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychosocial support for caregiverOther
6 weekly 60 minute sessions
questionnaire administrationOther
Evaluated at baseline, week 1 and week 6 of art therapy
quality-of-life assessmentProcedure or surgery
Evaluated at baseline, week 1 and week 6 of art therapy
stress management therapyProcedure or surgery
6 weekly 60 minute sessions
| Study group | Role | What they receive |
|---|---|---|
| Art Therapy | Experimental | Not described Receives: Other: psychosocial support for caregiver; Other: questionnaire administration; Procedure: quality-of-life assessment; Procedure: stress management therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional distress
Measured: Baseline, week 1 and week 6 of art therapy
Pro-social interactions
Measured: Baseline, week 1 and week 6 of art therapy
Illness experience of caregivers and how it is impacted by the art therapy intervention
Measured: Baseline, week 1 and week 6 of art therapy
Caregivers' current health-related quality of life and life meaning
Measured: Baseline, week 1 and week 6 of art therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJun 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.
- Other trials for Health Status UnknownStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kate Kravits, RN, MA, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922285
- Sponsor's protocol ID
- 08028
- Other IDs
- P30CA033572, CHNMC-08028, CDR0000642781
- Status last verified
- Jun 2015
- First submitted
- 16 Jun 2009
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Art Therapy Interventions With Caregivers Supporting Pediatric Patients Who Are Undergoing Bone Marrow Transplantation for Cancer
- ClinicalTrials.gov ID
- NCT00922285
- Acronym / sponsor ID
- 08028
- Keywords
- psychosocial effects of cancer and its treatment, health status unknown
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 17 Jun 2009 (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.
RATIONALE: Art therapy may help relieve emotional distress in caregivers of young patients undergoing bone marrow transplant for cancer.
PURPOSE: This clinical trial is studying art therapy for caregivers of young patients undergoing bone marrow transplant for cancer.
Detailed description
OBJECTIVES:
- Test the effects of an art therapy intervention on emotional distress in caregivers of pediatric patients undergoing bone marrow transplantation for cancer.
- Describe pro-social interactions of caregivers of pediatric patients undergoing bone marrow transplantation for cancer.
- Describe the illness experience of caregivers and how it is impacted by the art therapy intervention.
- Describe the caregivers' current health-related quality of life and life meaning prior to pediatric patients initiation of bone marrow transplantation for cancer.
- Determine the effect size for calculating the sample needed for a randomized clinical trial.
OUTLINE: Caregivers undergo art therapy over 60 minutes once a week for 6 weeks. Each session comprises developing trust through the expression of support, affirmation, and collaboration; creating intimacy through attunement; exploring affective states; integrative processing through the creation of an autobiographical narrative; and identifying opportunities for continued exploration and resources that support the client, should that exploration become necessary.
Caregivers also complete a Meaning of Life Questionnaire and a Family Quality of Life Scale at baseline and at the end of week 6.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Art Therapy | Experimental | Other: psychosocial support for caregiver, Other: questionnaire administration, Procedure: quality-of-life assessment, Procedure: stress management therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| psychosocial support for caregiver6 weekly 60 minute sessions | Other | Art Therapy |
| questionnaire administrationEvaluated at baseline, week 1 and week 6 of art therapy | Other | Art Therapy |
| quality-of-life assessmentEvaluated at baseline, week 1 and week 6 of art therapy | Procedure or surgery | Art Therapy |
| stress management therapy6 weekly 60 minute sessions | Procedure or surgery | Art Therapy |
Primary outcome
Emotional distress
Time frame: Baseline, week 1 and week 6 of art therapy
Pro-social interactions
Time frame: Baseline, week 1 and week 6 of art therapy
Illness experience of caregivers and how it is impacted by the art therapy intervention
Time frame: Baseline, week 1 and week 6 of art therapy
Caregivers' current health-related quality of life and life meaning
Time frame: Baseline, week 1 and week 6 of art therapy
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 8 Jun 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.
Kate Kravits, RN, MA principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychosocial support for caregiver, questionnaire administration and quality-of-life assessment in people with Health Status Unknown and Psychosocial Effects of Cancer and Its Treatment, run by City of Hope Medical Center 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?
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 Jun 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?
Emotional distress (time frame: Baseline, week 1 and week 6 of art therapy). The study lists 4 primary outcomes in all. 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 Jun 2015.