Treatment-Related Cancer Clinical Trial
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.
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.
1. 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.
2. 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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT00166686 -
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|
Phase 1/Phase 2 |