Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL)

NCT01404520 | Completed DMC

• 1 other identifier: H-4-2010-046
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

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]

Outcome Measures

Primary Outcomes (1)

• Six Minute Walk Distance 6MWD

  Change in distance in meter

  Change from baseline in 6MWD at 12 weeks

Secondary Outcomes (8)

• Estimated VO2 max Aastrand test

  Change from baseline in VO2 Aastrand test at 12 weeks

• Timed chair stand

  Change from baseline in timed chair stand at 12 weeks

• Timed biceps curl

  Change from baseline in timed bicep curl at 12 weeks

• EORTC QLQ-C30

  Change from baseline in EORTC QLQ-C30 at 12 weeks

• FACT-An

  Change from baseline in FACT-An at 12 weeks

Study Arms (2)

Exercise based multimodal intervention

EXPERIMENTAL

The intervention is initiated early, during treatment (consolidation) in the intra-hospital setting and continues for two successive treatment series (12 weeks). The intervention is a three hour/wk supervised in-hospital programme of aerobic (stationary cycle) and functional muscle training, progressive relaxation training, nutrition supplement (protein and carbohydrate) immediately after training and health-promoting consultation combined with an unsupervised in-home walking and progressive relaxation programme

Other: Exercise based multimodal intervention

Control Group

NO INTERVENTION

Control group receives usual care

Interventions

Exercise based multimodal intervention OTHER

The intervention is initiated early, during treatment (consolidation) in the intra-hospital setting and continues for two successive treatment series (12 weeks). The intervention is a three hour/wk supervised in-hospital programme of aerobic (stationary cycle) and functional muscle training, progressive relaxation training, nutrition supplement (protein and carbohydrate) immediately after training and health-promoting consultation combined with an unsupervised in-home walking and progressive relaxation programme.

Exercise based multimodal intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitetshospitalernes Center for Sygepleje: lead
• University of Copenhagen: collaborator
• Novo Nordisk A/S: collaborator
• Danish Cancer Society: collaborator
• Lundbeck Foundation: collaborator

Study Sites (2)

Copenhagen University Hospital Rigshospital

Copenhagen, DK 2100, Denmark

Location

Herlev Hospital

Herlev, DK 2730, Denmark

Location

Related Publications (2)

• 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.

  PMID: 27036163 DERIVED

• 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.

  PMID: 24083543 DERIVED

Study Officials

• Mary Jarden, Ph.D.

  UCSF and CIRE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: May 10, 2011
• First Posted: July 28, 2011
• Study Start: June 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

DK (2)