NCT01035203

Brief Summary

The investigators compare the effects of two interventions, an endurance exercise program and a cognitive behavioural therapy, on the fatigue, quality of life, mood and physical performance of patients with a cancer-related fatigue syndrome. The intervention will be carried out for 4 weeks. Tests will be carried out at the beginning and at the end of the study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

March 30, 2010

Status Verified

March 1, 2010

Enrollment Period

7 months

First QC Date

December 17, 2009

Last Update Submit

March 29, 2010

Conditions

FatigueMoodMaximal Oxygen Uptake

Outcome Measures

Primary Outcomes (1)

  • Fatigue scores on the Brief Fatigue Inventory (BFI)

    4 weeks

Secondary Outcomes (2)

  • Maximal oxygen uptake (VO2max) on a treadmill stress test.

    4 weeks

  • Scores on the HADS (Hospital Anxiety and Depression Scale)

    4 weeks

Study Arms (2)

Cognitive behavioural therapy

ACTIVE COMPARATOR
Behavioral: Cognitive behavioural therapy

Exercise

EXPERIMENTAL

Endurance training (walking on a treadmill) 3 x weekly for 4 weeks

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Endurance exercise 3 times weekly for 45 minutes, 4 weeks long

Exercise
Cognitive behavioural therapyBEHAVIORAL

Teaching of techniques to reduce fatigue and to improve stamina

Cognitive behavioural therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70
  • Histologically confirmed neoplastic disease
  • Treatment (chemotherapy or radiation) completed.
  • No treatment in the previous 4 weeks
  • Ability to understand written German

You may not qualify if:

  • Health conditions which can be aggravated by exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Sports Medicine

Berlin, State of Berlin, 14167, Germany

RECRUITING

MeSH Terms

Conditions

Fatigue

Interventions

ExerciseCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Fernando Dimeo, MD

CONTACT

+493084452098fernando.dimeo@charite.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2009

First Posted

December 18, 2009

Study Start

December 1, 2009

Primary Completion

July 1, 2010

Study Completion

September 1, 2010

Last Updated

March 30, 2010

Record last verified: 2010-03

Locations

DE(1)