Clinical trial NCT01404520: Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL)
Official title: Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL) Health Promoting Rehabilitation. A Multimodal Exercise-based Intervention in Patients With Acute Leukaemia Undergoing Re-induction or Consolidation Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Leukemia
Keywords: #14 Cancer Related fatigue
#13 Quality of Life
#12 "Psychosocial Intervention"[ti/ab]
#11 Rehabilitation[tw]
#10 "Physical Fitness"[tw]
#9 "Physical Activity"[tw]
#8 "Exercise Therapy"[tw]
#7 Exercise[tw]
#6 Hematologic[tw]
#5 Hematological[tw]
#4 Leukemia, Myeloid, Acute[mh]
#3 "Acute Myeloid Leukemia"[tw]
#2 "Acute Lymphoblastic Leukemia"[tw]
#1 "Acute Leukemia"[tw]
Lead sponsor: Universitetshospitalernes Center for Sygepleje
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Novo Nordisk A/S
name: Danish Cancer Society
name: Lundbeck Foundation
First posted: 2011-07-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test a new preventive and restorative intervention for patients with acute leukaemia undergoing consolidation chemotherapy, to measure and delineate the patients' treatment related symptom burden and to explore the effect of the intervention on length of hospital stay, duration of sick leave and return to work status. Further, to examine the relationship of the symptom profile with clinical indicators, physiological response, physical performance and survival.


Eligibility criteria: Inclusion Criteria:

* Patients that are able to speak Danish \> 18 years and newly diagnosed with acute leukæmia (MDS, AML, CMML, APL or ALL)
* Normal EKG, blood pressure and pulse
* Signed informed written consent

Exclusion Criteria:

* Medical reason that contraindicates physical activity
* Patients diagnosed with a symptomatic cardial disease
* Documented bone metastasis
* Cognitively or emotionally unstable
* Unable to read or write in Danish
* Patients unable to carry out baseline tests

Primary outcomes:
measure: Six Minute Walk Distance 6MWD
timeFrame: Change from baseline in 6MWD at 12 weeks
Secondary outcomes:
measure: Estimated VO2 max Aastrand test
timeFrame: Change from baseline in VO2 Aastrand test at 12 weeks
measure: Timed chair stand
timeFrame: Change from baseline in timed chair stand at 12 weeks
measure: Timed biceps curl
timeFrame: Change from baseline in timed bicep curl at 12 weeks
measure: EORTC QLQ-C30
timeFrame: Change from baseline in EORTC QLQ-C30 at 12 weeks
measure: FACT-An
timeFrame: Change from baseline in FACT-An at 12 weeks
measure: HADS
timeFrame: Change from baseline in HADS at 12 weeks
measure: SF36
timeFrame: Change from baseline in SF36 at 12 weeks
measure: MDASI
timeFrame: Change from baseline over time (1,2,3,4,5,6,7,8,9,10,11,12 weeks)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital Rigshospital
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: UCSF and CIRE
name: Mary Jarden, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jarden M, Moller T, Christensen KB, Kjeldsen L, Birgens HS, Adamsen L. Multimodal intervention integrated into the clinical management of acute leukemia improves physical function and quality of life during consolidation chemotherapy: a randomized trial 'PACE-AL'. Haematologica. 2016 Jul;101(7):e316-9. doi: 10.3324/haematol.2015.140152. Epub 2016 Apr 1. No abstract available.
citation: Jarden M, Moller T, Kjeldsen L, Birgens H, Christensen JF, Bang Christensen K, Diderichsen F, Hendriksen C, Adamsen L. Patient Activation through Counseling and Exercise--Acute Leukemia (PACE-AL)--a randomized controlled trial. BMC Cancer. 2013 Oct 2;13:446. doi: 10.1186/1471-2407-13-446.