Treatment-Related CancerACT-CCNCT03313193
Acupressure for Children in Treatment for a Childhood Cancer
A study testing Acupressure for Children in Treatment for a Childhood Cancer in people with Treatment-Related Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
Background: Despite advances in symptom management, children undergoing cancer treatment or receiving a chemotherapy-based Hematopoietic Stem Cell Transplant (HSCT) often suffer from moderate to severe symptoms of nausea/vomiting, pain, and fatigue along with psychological distress. Read more about this study
- Who is it for?
- Ages 5 to 24 years
- Conditions the study is for
- Treatment-Related Cancer
- What is being tested?
- Acupressure for Children in Treatment for a Childhood Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2017to 1 Oct 2019
- 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 5 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children who are either receiving treatment for diagnosis of a childhood cancer (curative or supportive care) or are receiving a chemotherapy-based HSCT. Non-malignant brain central nervous system tumors are considered as a childhood cancer.
- Ages 5- 24 years old.
- Be receiving hospital-based treatment (inpatient or outpatient) so that acupressure treatments can be delivered and parents can be trained and monitored.
- Availability and willingness of a parent or caregiver to deliver acupressure for ages 5-17. For young adults ages 18-24 participation of a parent, close friend or family member/caregiver is preferred but not required.
- English or Spanish speaking.
- Receiving treatment at UCSF Benioff Children's Hospital.
Who cannot join
- 1) Children/young adults who meet the above criteria, but whose treating oncologist, health care provider, or a study investigator advises against study participation for physical health, mental health (parent or child) or logistical reasons.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: Acupressure Intervention to Reduce Treatment-related Symptoms in Children With Cancer or Receiving a Hematopoietic Stem Cell Transplant
Background: Despite advances in symptom management, children undergoing cancer treatment or receiving a chemotherapy-based Hematopoietic Stem Cell Transplant (HSCT) often suffer from moderate to severe symptoms of nausea/vomiting, pain, and fatigue along with psychological distress. Pharmacologic treatments of symptoms can cause side-effects. Patients, parents, and clinicians have expressed interest in including non-pharmacologic approaches to improve symptom management. Acupuncture/acupressure is a promising adjunctive therapy to usual care. More evidence is needed from well-designed trials with larger samples and rigorous designs in order to make definitive recommendations about the routine inclusion of acupressure among pediatric patients being treated for childhood cancer or receiving a HSCT.
Design and Methods 100 dyads (one child with one parent/caregiver) will be randomized 1:1 into 2 study arms (50 children in each arm). Arm A participants will be offered usual care and professional acupressure five times weekly (15-20 minute sessions) and a parent/caregiver will be instructed in acupressure delivery for the child as symptoms arise. Arm B participants will receive usual care alone. (At the study end, Arm B parents will be offered acupressure instructions.) Children will be enrolled for ~30 days which can occur with one month of continuous hospital-based treatment or two months of intermittent hospital-based treatment (inpatient or regular outpatient treatment). Parent and child participants will receive a follow-up interview one month after completion of the intervention (Arm A) or the final symptom assessment (Arm B).
Significance This is the first study to evaluate the effectiveness and safety of an acupressure intervention to decrease treatment-related symptoms in 100 patients in treatment for a childhood cancer or receiving a chemo-therapy based HSCT.
Read the detailed description
AIMS
Aim 1: To assess the feasibility of an acupressure intervention plus usual care and to assess the benefits and risks compared to usual care alone for children receiving hospital-based treatment for a childhood cancer or a HSCT. The study hypothesizes that patients in the acupressure arm will report decreased nausea/vomiting and improved management of treatment -related symptoms compared to the usual care only arm. We will test the following hypotheses:
1a. Primary outcomes: Children receiving acupressure will report reduced nausea/vomiting measured as a composite variable compared to the usual care alone group.
1b. Secondary outcomes: Children receiving the acupressure intervention will have reduced levels of each; nausea, vomiting, and rescue antiemetic use compared to the usual care alone group.
1c. Secondary outcomes: Children receiving acupressure will report reduced pain interference and pain intensity, reduced fatigue, anxiety, depression, other treatment-related symptoms, and greater positive affect compared to the usual care group. Children receiving acupressure will use less rescue pain medication compared to the usual care alone group.
- d. Greater dose of acupressure will lead to greater improvement of primary and secondary outcomes. Aim 2: To assess the benefits and challenges of providing the acupressure intervention for parents.
- a. The parent/caregiver in Arm A will report decreased post-traumatic stress symptoms, reduced anxiety and depression, and increased caregiving self-efficacy 4 weeks after the end of professional acupressure. 2b. An open-ended question for parents/caregivers in the intervention arm will elicit information on the experience of providing acupressure for their children.
Additional Qualitative Aims:
Qualitative Aim 1: To explore the child's experience of receiving acupressure and the caregiver's experience of delivering acupressure to the child through a semi-structured interview with the caregiver, with a focus on well-being. We will explore how acupressure impacts the proposed components of well- being: hedonistic and eudemonic perspectives of positive feelings, as well as the less studied somatic and physical components such as mind-body integration and increased connection through touch in the child and caregiver.
Qualitative Aim 2: To explore the acupressure provider's impression of how provider- or caregiver- delivered acupressure impacts the child's experience of childhood cancer treatment or HSCT.
DESIGN The goal of the study is to describe the benefits and risks of an acupressure intervention to decrease nausea/vomiting and other treatment-related symptoms compared to a control group receiving usual care. This study is a pragmatic randomized clinical trial. Participants will be randomized 1:1 into 2 study arms. In Arm A children will be offered professional acupressure five times weekly along with usual care for ~30 days of hospital-based treatment (continuous in-hospital) or two months of hospital-based treatment (intermittent) for an approximate total of 20 semi-standardized acupressure treatments. Treatments take approximately 20 minutes each. A parent/caregiver will be instructed in how to deliver acupressure to his/her child as symptoms arise using a simplified protocol with supplemental educational handouts. In Arm B participants will receive usual care alone. All usual care is defined according to COG supportive care guidelines. After the final study assessment parents/caregivers will be given instruction on how to deliver acupressure. Outcomes will be assessed in all children in Arm A and Arm B at baseline, 5 days a week for nausea, vomiting, and pain, two times a week for remaining symptoms, and at a once month follow-up. Outcomes will be assessed in caregivers at baseline, ~day 7, and at follow-up.
- Conditions
- Treatment-Related Cancer
- Being tested
- Acupressure for Children in Treatment for a Childhood Cancer
- Keywords
- nausea, vomiting, pain, fatigue, depression, anxiety, PTSD-parent, caregiver self efficacy-parent
- Medical subject headings
- Neoplasms, Second Primary, Nausea, Vomiting, Pain, Fatigue, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure for Children in Treatment for a Childhood CancerOther
This study will describe the benefits and risks of an acupressure intervention to decrease nausea/vomiting and other treatment-related symptoms compared to a control group receiving usual care. Children in Arm A will receive usual symptom management care + acupressure 5 days/week for ~20 treatments. Parents will be taught how to provide acupressure as well. Children in Arm B will receive usual care alone.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Acupressure for Children in Treatment for a Childhood Cancer + usual care Receives: Other: Acupressure for Children in Treatment for a Childhood Cancer |
| Arm B | No intervention | Usual care alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in nausea/vomiting severity
assessed using the Pediatric Nausea Assessment Tool (PeNAT)(Dupuis, 2006)(see description below) + a single Question on vomiting for ages 5-17. The MASCC Anti-emesis Tool (MAT) will be used to assess nausea (yes/no) and severity for ages 18+.This composite measure of nausea/vomiting in the child represents a continuum of nausea/vomiting (range=1-8).
Measured: past 24 hours for nausea/vomiting measures daily over 30 days of hospital-based treatment (continuous hospitalization or intermittent treatment over 2 months)
Secondary outcomes (16)
Decreased nausea (PeNAT)
Nausea will be measured using the PeNat scale, validated for ages 4-17 years. Four levels of nausea are defined on this scale: none, mild, moderate and severe, using faces, a preferred method of measuring distress among children. In the case where a child cannot report on nausea, parent report will be sought. Parents report of child's nausea severity was found to be significantly correlated with child reports. Patients ages 18-24 will be given the MAT.
Measured: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Decreased vomiting (Vol, 2016)
Vomiting episodes will be measured as recorded by patients and families using patient diaries (confirmed using review of daily patient electronic medical records (EMR)). Vomiting episodes will be capped so the range will be 1-4+ episodes in the 2 day time-span since the last assessment. Using these two variables we can construct a variable for no nausea and no vomiting which is typically called "complete control" and is a standard outcome for many pharmaceutical antiemetic trials.
Measured: 30 days hospitalization (continuous or intermittent over 2 months)
Use of fewer rescue anti-emetics (from Electronic Medical Records)
This will be categorized as a 1-4+ variable where 1=no rescue antiemetic use and 4+ means that a dose was taken 4 or more times between assessments. (Emetogenicity will be assessed using the newest guidelines.) From electronic medical records (EMR).
Measured: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Complete control of nausea/vomiting
Using the nausea and vomiting variables we will construct a dichotomous variable for no nausea and no vomiting which is typically called "complete control" and is a standard outcome for many pharmaceutical antiemetic trials.
Measured: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Decreased pain interference assessed using the PROMIS Pediatric Pain Interference Scale
(4 items) from the Pediatric Profile 25 v. 2. Pediatric or Parent Proxy Versions assess pain interference in the context of daily activities including interference on physical, psychological and social functioning. (Varni, 2010)
Measured: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Decreased Pain intensity
PROMIS Pediatric or Parent Proxy Version includes 1 question that assesses intensity of pain on a 0-10 scale. This single-item pain intensity question is included in the Pediatric Profile 25 v2 and is not scored but reported using a raw score (e.g., 0 to 10).
Measured: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Decreased pain assessed (ages 5-7)
Faces Pain (Intensity) Scale-Revised (FPS-R)(1 item) children rank severity of pain using 6 gender-neutral faces depicting 'no pain' to 'most pain'; scores range from 0 to 10.
Measured: 30 days of hospital-based treatment (continuous or intermittent over 2 months)
Decreased fatigue symptoms
PROMIS Pediatric Profile 25 v2. This 4-item scale includes two domains: feeling tired and (lack of) energy and its impact on daily life.
Measured: 30 days of hospital-based treatment (continuous or intermittent over 2 months)
Decreased depression symptoms
(4 items) from PROMIS pediatric profile 25 v 2.0 Among young adults aged 18+. 4-item subscales of PROMIS Adult Profile 29 v2.0 will be used.
Measured: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Decreased anxiety
(4 items) from PROMIS pediatric profile 25 v 2.0
Measured: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Increased Well-being
PROMIS Pediatric Positive Affect measure. This measures positive emotions (well-being) which can reduce experience of symptom burden and protect health. (4 items) Among parents/caregivers the study used Positive Affect Subscale of the PANAS (5-items): This positive affect sub-scale of the 10-item PANAS scale (i-PANAS-SF) assesses positive or pleasurable engagement with the environment, well-being, and satisfaction with life.
Measured: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Fewer overall symptoms assessed using the Symptom Screening in Pediatrics (SSPedi) tool (Tomlinson, 2014)
This pediatric cancer-specific symptom screening and assessment scale measures physical and psychological symptoms (e.g., feeling angry, sad or worried, tired, mouth sores, headache, constipation or diarrhea, problems thinking or remembering, body changes, or appetite loss, among others) in 15 questions.
Measured: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Decreased depression symptoms using the PROMIS depression (adult) measure.
4 item measure used to assess depression among the child's parent/caregiver using subscales of PROMIS Adult Profile 29 v2.0 will be used.
Measured: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Decreased anxiety assessed using PROMIS anxiety (adult)
4 item measure used to assess anxiety among the child's parent/caregiver using subscales of PROMIS Adult Profile 29 v2.0 will be used.
Measured: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Fewer PTSD symptoms, (PCL-5) (adult)
the Post-traumatic Stress Disorder Checklist is a 20 item measure - updated to use DSM5 criteria. Responses assess frequency and intensity of symptoms (strong internal consistency, test-retest reliability and validity). Total symptom scores will be compared between groups.
Measured: 1 month after end of 30 days trial enrollment
Increased Caregiver Self-Efficacy (parent)
This 6 item scale is adapted from Bandura, 1977, Lorig, 1989; Barlow, 2000) and previously used in parents of children with disabilities (excellent psychometric reliability and validity).
Measured: 1 month after end of 30 day trial enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start26 Sep 2017
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Treatment-Related CancerStudies 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
- Model description
- Pragmatic Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Pierre's Birthday Fund
- Responsible party
- Principal investigator, Anne Lown, University of California, San Francisco
- Investigators
- Anne Lown, Dr.P.H., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313193
- Sponsor's protocol ID
- 170820
- Acronym
- ACT-CC
- Status last verified
- Oct 2019
- First submitted
- 22 Aug 2017
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roscoe JA, Morrow GR, Hickok JT, Bushunow P, Pierce HI, Flynn PJ, Kirshner JJ, Moore DF, Atkins JN. The efficacy of acupressure and acustimulation wrist bands for the relief of chemotherapy-induced nausea and vomiting. A University of Rochester Cancer Center Community Clinical Oncology Program multicenter study. J Pain Symptom Manage. 2003 Aug;26(2):731-42. doi: 10.1016/s0885-3924(03)00254-9.
PubMed 12906958Mao JJ, Xie SX, Bowman MA. Uncovering the expectancy effect: the validation of the acupuncture expectancy scale. Altern Ther Health Med. 2010 Nov-Dec;16(6):22-7.
PubMed 21280459Forrest CB, Bevans KB, Tucker C, Riley AW, Ravens-Sieberer U, Gardner W, Pajer K. Commentary: the patient-reported outcome measurement information system (PROMIS(R)) for children and youth: application to pediatric psychology. J Pediatr Psychol. 2012 Jul;37(6):614-21. doi: 10.1093/jpepsy/jss038. Epub 2012 Feb 23. No abstract available.
PubMed 22362923Garcia SF, Cella D, Clauser SB, Flynn KE, Lad T, Lai JS, Reeve BB, Smith AW, Stone AA, Weinfurt K. Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative. J Clin Oncol. 2007 Nov 10;25(32):5106-12. doi: 10.1200/JCO.2007.12.2341.
PubMed 17991929DeWitt EM, Stucky BD, Thissen D, Irwin DE, Langer M, Varni JW, Lai JS, Yeatts KB, Dewalt DA. Construction of the eight-item patient-reported outcomes measurement information system pediatric physical function scales: built using item response theory. J Clin Epidemiol. 2011 Jul;64(7):794-804. doi: 10.1016/j.jclinepi.2010.10.012. Epub 2011 Feb 2.
PubMed 21292444Irwin DE, Stucky B, Langer MM, Thissen D, Dewitt EM, Lai JS, Varni JW, Yeatts K, DeWalt DA. An item response analysis of the pediatric PROMIS anxiety and depressive symptoms scales. Qual Life Res. 2010 May;19(4):595-607. doi: 10.1007/s11136-010-9619-3. Epub 2010 Mar 7.
PubMed 20213516Varni JW, Stucky BD, Thissen D, Dewitt EM, Irwin DE, Lai JS, Yeatts K, Dewalt DA. PROMIS Pediatric Pain Interference Scale: an item response theory analysis of the pediatric pain item bank. J Pain. 2010 Nov;11(11):1109-19. doi: 10.1016/j.jpain.2010.02.005. Epub 2010 Jun 2.
PubMed 20627819Kashikar-Zuck S, Carle A, Barnett K, Goldschneider KR, Sherry DD, Mara CA, Cunningham N, Farrell J, Tress J, DeWitt EM. Longitudinal evaluation of patient-reported outcomes measurement information systems measures in pediatric chronic pain. Pain. 2016 Feb;157(2):339-347. doi: 10.1097/j.pain.0000000000000378.
PubMed 26447704Varni JW, Thissen D, Stucky BD, Liu Y, Gorder H, Irwin DE, DeWitt EM, Lai JS, Amtmann D, DeWalt DA. PROMIS(R) Parent Proxy Report Scales: an item response theory analysis of the parent proxy report item banks. Qual Life Res. 2012 Sep;21(7):1223-40. doi: 10.1007/s11136-011-0025-2. Epub 2011 Oct 5.
PubMed 21971875Irwin DE, Gross HE, Stucky BD, Thissen D, DeWitt EM, Lai JS, Amtmann D, Khastou L, Varni JW, DeWalt DA. Development of six PROMIS pediatrics proxy-report item banks. Health Qual Life Outcomes. 2012 Feb 22;10:22. doi: 10.1186/1477-7525-10-22.
PubMed 22357192Hinds PS, Nuss SL, Ruccione KS, Withycombe JS, Jacobs S, DeLuca H, Faulkner C, Liu Y, Cheng YI, Gross HE, Wang J, DeWalt DA. PROMIS pediatric measures in pediatric oncology: valid and clinically feasible indicators of patient-reported outcomes. Pediatr Blood Cancer. 2013 Mar;60(3):402-8. doi: 10.1002/pbc.24233. Epub 2012 Jul 24.
PubMed 22829446Lai JS, Stucky BD, Thissen D, Varni JW, DeWitt EM, Irwin DE, Yeatts KB, DeWalt DA. Development and psychometric properties of the PROMIS((R)) pediatric fatigue item banks. Qual Life Res. 2013 Nov;22(9):2417-27. doi: 10.1007/s11136-013-0357-1. Epub 2013 Feb 2.
PubMed 23378106Vol H, Flank J, Lavoratore SR, Nathan PC, Taylor T, Zelunka E, Maloney AM, Lee Dupuis L. Poor chemotherapy-induced nausea and vomiting control in children receiving intermediate or high dose methotrexate. Support Care Cancer. 2016 Mar;24(3):1365-71. doi: 10.1007/s00520-015-2924-1. Epub 2015 Sep 3.
PubMed 26335406Dupuis LL, Taddio A, Kerr EN, Kelly A, MacKeigan L. Development and validation of the pediatric nausea assessment tool for use in children receiving antineoplastic agents. Pharmacotherapy. 2006 Sep;26(9):1221-31. doi: 10.1592/phco.26.9.1221.
PubMed 16945043Dupuis LL. Chemotherapy-induced vomiting in children: some progress, more questions. Lancet Oncol. 2016 Mar;17(3):264-265. doi: 10.1016/S1470-2045(15)00582-3. Epub 2016 Jan 19. No abstract available.
PubMed 26795845
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupressure Intervention to Reduce Treatment-related Symptoms in Children With Cancer or Receiving a Hematopoietic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT03313193
- Acronym / sponsor ID
- ACT-CC / 170820
- Conditions
- Treatment-Related Cancer
- Keywords
- nausea, vomiting, pain, fatigue, depression, anxiety, PTSD-parent, caregiver self efficacy-parent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Pierre's Birthday Fund
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 18 Oct 2017 (actual)
- 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.
Background: Despite advances in symptom management, children undergoing cancer treatment or receiving a chemotherapy-based Hematopoietic Stem Cell Transplant (HSCT) often suffer from moderate to severe symptoms of nausea/vomiting, pain, and fatigue along with psychological distress. Pharmacologic treatments of symptoms can cause side-effects. Patients, parents, and clinicians have expressed interest in including non-pharmacologic approaches to improve symptom management. Acupuncture/acupressure is a promising adjunctive therapy to usual care. More evidence is needed from well-designed trials with larger samples and rigorous designs in order to make definitive recommendations about the routine inclusion of acupressure among pediatric patients being treated for childhood cancer or receiving a HSCT.
Design and Methods 100 dyads (one child with one parent/caregiver) will be randomized 1:1 into 2 study arms (50 children in each arm). Arm A participants will be offered usual care and professional acupressure five times weekly (15-20 minute sessions) and a parent/caregiver will be instructed in acupressure delivery for the child as symptoms arise. Arm B participants will receive usual care alone. (At the study end, Arm B parents will be offered acupressure instructions.) Children will be enrolled for ~30 days which can occur with one month of continuous hospital-based treatment or two months of intermittent hospital-based treatment (inpatient or regular outpatient treatment). Parent and child participants will receive a follow-up interview one month after completion of the intervention (Arm A) or the final symptom assessment (Arm B).
Significance This is the first study to evaluate the effectiveness and safety of an acupressure intervention to decrease treatment-related symptoms in 100 patients in treatment for a childhood cancer or receiving a chemo-therapy based HSCT.
Detailed description
AIMS
Aim 1: To assess the feasibility of an acupressure intervention plus usual care and to assess the benefits and risks compared to usual care alone for children receiving hospital-based treatment for a childhood cancer or a HSCT. The study hypothesizes that patients in the acupressure arm will report decreased nausea/vomiting and improved management of treatment -related symptoms compared to the usual care only arm. We will test the following hypotheses:
1a. Primary outcomes: Children receiving acupressure will report reduced nausea/vomiting measured as a composite variable compared to the usual care alone group.
1b. Secondary outcomes: Children receiving the acupressure intervention will have reduced levels of each; nausea, vomiting, and rescue antiemetic use compared to the usual care alone group.
1c. Secondary outcomes: Children receiving acupressure will report reduced pain interference and pain intensity, reduced fatigue, anxiety, depression, other treatment-related symptoms, and greater positive affect compared to the usual care group. Children receiving acupressure will use less rescue pain medication compared to the usual care alone group.
- d. Greater dose of acupressure will lead to greater improvement of primary and secondary outcomes. Aim 2: To assess the benefits and challenges of providing the acupressure intervention for parents.
- a. The parent/caregiver in Arm A will report decreased post-traumatic stress symptoms, reduced anxiety and depression, and increased caregiving self-efficacy 4 weeks after the end of professional acupressure. 2b. An open-ended question for parents/caregivers in the intervention arm will elicit information on the experience of providing acupressure for their children.
Additional Qualitative Aims:
Qualitative Aim 1: To explore the child's experience of receiving acupressure and the caregiver's experience of delivering acupressure to the child through a semi-structured interview with the caregiver, with a focus on well-being. We will explore how acupressure impacts the proposed components of well- being: hedonistic and eudemonic perspectives of positive feelings, as well as the less studied somatic and physical components such as mind-body integration and increased connection through touch in the child and caregiver.
Qualitative Aim 2: To explore the acupressure provider's impression of how provider- or caregiver- delivered acupressure impacts the child's experience of childhood cancer treatment or HSCT.
DESIGN The goal of the study is to describe the benefits and risks of an acupressure intervention to decrease nausea/vomiting and other treatment-related symptoms compared to a control group receiving usual care. This study is a pragmatic randomized clinical trial. Participants will be randomized 1:1 into 2 study arms. In Arm A children will be offered professional acupressure five times weekly along with usual care for ~30 days of hospital-based treatment (continuous in-hospital) or two months of hospital-based treatment (intermittent) for an approximate total of 20 semi-standardized acupressure treatments. Treatments take approximately 20 minutes each. A parent/caregiver will be instructed in how to deliver acupressure to his/her child as symptoms arise using a simplified protocol with supplemental educational handouts. In Arm B participants will receive usual care alone. All usual care is defined according to COG supportive care guidelines. After the final study assessment parents/caregivers will be given instruction on how to deliver acupressure. Outcomes will be assessed in all children in Arm A and Arm B at baseline, 5 days a week for nausea, vomiting, and pain, two times a week for remaining symptoms, and at a once month follow-up. Outcomes will be assessed in caregivers at baseline, ~day 7, and at follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Other: Acupressure for Children in Treatment for a Childhood CancerAcupressure for Children in Treatment for a Childhood Cancer + usual care |
| Arm B | No intervention | –Usual care alone |
Who may qualify
- Ages
- 5 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Children who are either receiving treatment for diagnosis of a childhood cancer (curative or supportive care) or are receiving a chemotherapy-based HSCT. Non-malignant brain central nervous system tumors are considered as a childhood cancer.
- Ages 5- 24 years old.
- Be receiving hospital-based treatment (inpatient or outpatient) so that acupressure treatments can be delivered and parents can be trained and monitored.
- Availability and willingness of a parent or caregiver to deliver acupressure for ages 5-17. For young adults ages 18-24 participation of a parent, close friend or family member/caregiver is preferred but not required.
- English or Spanish speaking.
Key exclusion criteria (1 listed)
- 1) Children/young adults who meet the above criteria, but whose treating oncologist, health care provider, or a study investigator advises against study participation for physical health, mental health (parent or child) or logistical reasons.
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 |
|---|---|---|
| Acupressure for Children in Treatment for a Childhood CancerThis study will describe the benefits and risks of an acupressure intervention to decrease nausea/vomiting and other treatment-related symptoms compared to a control group receiving usual care. Children in Arm A will receive usual symptom management care + acupressure 5 days/week for ~20 treatments. Parents will be taught how to provide acupressure as well. Children in Arm B will receive usual care alone. | Other | Arm A |
Primary outcome
Decrease in nausea/vomiting severity
Time frame: past 24 hours for nausea/vomiting measures daily over 30 days of hospital-based treatment (continuous hospitalization or intermittent treatment over 2 months)
assessed using the Pediatric Nausea Assessment Tool (PeNAT)(Dupuis, 2006)(see description below) + a single Question on vomiting for ages 5-17. The MASCC Anti-emesis Tool (MAT) will be used to assess nausea (yes/no) and severity for ages 18+.This composite measure of nausea/vomiting in the child represents a continuum of nausea/vomiting (range=1-8).
16 secondary outcomes
Decreased nausea (PeNAT)
Time frame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Decreased vomiting (Vol, 2016)
Time frame: 30 days hospitalization (continuous or intermittent over 2 months)
Use of fewer rescue anti-emetics (from Electronic Medical Records)
Time frame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Complete control of nausea/vomiting
Time frame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Decreased pain interference assessed using the PROMIS Pediatric Pain Interference Scale
Time frame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Decreased Pain intensity
Time frame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Decreased pain assessed (ages 5-7)
Time frame: 30 days of hospital-based treatment (continuous or intermittent over 2 months)
Decreased fatigue symptoms
Time frame: 30 days of hospital-based treatment (continuous or intermittent over 2 months)
Decreased depression symptoms
Time frame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Decreased anxiety
Time frame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Increased Well-being
Time frame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Fewer overall symptoms assessed using the Symptom Screening in Pediatrics (SSPedi) tool (Tomlinson, 2014)
Time frame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Decreased depression symptoms using the PROMIS depression (adult) measure.
Time frame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Decreased anxiety assessed using PROMIS anxiety (adult)
Time frame: 30 days hospital-based treatment (continuous or intermittent over 2 months)
Fewer PTSD symptoms, (PCL-5) (adult)
Time frame: 1 month after end of 30 days trial enrollment
Increased Caregiver Self-Efficacy (parent)
Time frame: 1 month after end of 30 day trial enrollment
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 11 Oct 2019.
- Background: PubMed 12906958Roscoe JA, Morrow GR, Hickok JT, Bushunow P, Pierce HI, Flynn PJ, Kirshner JJ, Moore DF, Atkins JN. The efficacy of acupressure and acustimulation wrist bands for the relief of chemotherapy-induced nausea and vomiting. A University of Rochester Cancer Center Community Clinical Oncology Program multicenter study. J Pain Symptom Manage. 2003 Aug;26(2):731-42. doi: 10.1016/s0885-3924(03)00254-9.
- Background: PubMed 21280459Mao JJ, Xie SX, Bowman MA. Uncovering the expectancy effect: the validation of the acupuncture expectancy scale. Altern Ther Health Med. 2010 Nov-Dec;16(6):22-7.
- Background: PubMed 22362923Forrest CB, Bevans KB, Tucker C, Riley AW, Ravens-Sieberer U, Gardner W, Pajer K. Commentary: the patient-reported outcome measurement information system (PROMIS(R)) for children and youth: application to pediatric psychology. J Pediatr Psychol. 2012 Jul;37(6):614-21. doi: 10.1093/jpepsy/jss038. Epub 2012 Feb 23. No abstract available.
- Background: PubMed 17991929Garcia SF, Cella D, Clauser SB, Flynn KE, Lad T, Lai JS, Reeve BB, Smith AW, Stone AA, Weinfurt K. Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative. J Clin Oncol. 2007 Nov 10;25(32):5106-12. doi: 10.1200/JCO.2007.12.2341.
- Background: PubMed 21292444DeWitt EM, Stucky BD, Thissen D, Irwin DE, Langer M, Varni JW, Lai JS, Yeatts KB, Dewalt DA. Construction of the eight-item patient-reported outcomes measurement information system pediatric physical function scales: built using item response theory. J Clin Epidemiol. 2011 Jul;64(7):794-804. doi: 10.1016/j.jclinepi.2010.10.012. Epub 2011 Feb 2.
- Background: PubMed 20213516Irwin DE, Stucky B, Langer MM, Thissen D, Dewitt EM, Lai JS, Varni JW, Yeatts K, DeWalt DA. An item response analysis of the pediatric PROMIS anxiety and depressive symptoms scales. Qual Life Res. 2010 May;19(4):595-607. doi: 10.1007/s11136-010-9619-3. Epub 2010 Mar 7.
- Background: PubMed 20627819Varni JW, Stucky BD, Thissen D, Dewitt EM, Irwin DE, Lai JS, Yeatts K, Dewalt DA. PROMIS Pediatric Pain Interference Scale: an item response theory analysis of the pediatric pain item bank. J Pain. 2010 Nov;11(11):1109-19. doi: 10.1016/j.jpain.2010.02.005. Epub 2010 Jun 2.
- Background: PubMed 26447704Kashikar-Zuck S, Carle A, Barnett K, Goldschneider KR, Sherry DD, Mara CA, Cunningham N, Farrell J, Tress J, DeWitt EM. Longitudinal evaluation of patient-reported outcomes measurement information systems measures in pediatric chronic pain. Pain. 2016 Feb;157(2):339-347. doi: 10.1097/j.pain.0000000000000378.
- Background: PubMed 21971875Varni JW, Thissen D, Stucky BD, Liu Y, Gorder H, Irwin DE, DeWitt EM, Lai JS, Amtmann D, DeWalt DA. PROMIS(R) Parent Proxy Report Scales: an item response theory analysis of the parent proxy report item banks. Qual Life Res. 2012 Sep;21(7):1223-40. doi: 10.1007/s11136-011-0025-2. Epub 2011 Oct 5.
- Background: PubMed 22357192Irwin DE, Gross HE, Stucky BD, Thissen D, DeWitt EM, Lai JS, Amtmann D, Khastou L, Varni JW, DeWalt DA. Development of six PROMIS pediatrics proxy-report item banks. Health Qual Life Outcomes. 2012 Feb 22;10:22. doi: 10.1186/1477-7525-10-22.
- Background: PubMed 22829446Hinds PS, Nuss SL, Ruccione KS, Withycombe JS, Jacobs S, DeLuca H, Faulkner C, Liu Y, Cheng YI, Gross HE, Wang J, DeWalt DA. PROMIS pediatric measures in pediatric oncology: valid and clinically feasible indicators of patient-reported outcomes. Pediatr Blood Cancer. 2013 Mar;60(3):402-8. doi: 10.1002/pbc.24233. Epub 2012 Jul 24.
- Background: PubMed 23378106Lai JS, Stucky BD, Thissen D, Varni JW, DeWitt EM, Irwin DE, Yeatts KB, DeWalt DA. Development and psychometric properties of the PROMIS((R)) pediatric fatigue item banks. Qual Life Res. 2013 Nov;22(9):2417-27. doi: 10.1007/s11136-013-0357-1. Epub 2013 Feb 2.
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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.
Anne Lown, Dr.P.H. principal investigator
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 Acupressure for Children in Treatment for a Childhood Cancer in people with Treatment-Related Cancer, 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 6 inclusion and 1 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 11 Oct 2019. 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?
Decrease in nausea/vomiting severity (time frame: past 24 hours for nausea/vomiting measures daily over 30 days of hospital-based treatment (continuous hospitalization or intermittent treatment over 2 months)). 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 NCT03313193, which also lists 23 linked publications.
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 11 Oct 2019.