Exercise Versus Cognitive Behavioural Therapy on Cancer-r... | NCT01035203

Studies
Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue

NCT01035203

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Mar 30, 2010Estimated

Enrollment

60Estimated

Phase

Phase 3

Conditions

Fatigue
Mood
Maximal Oxygen Uptake

Interventions

Exercise
Cognitive behavioural therapy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Jul 2010Estimated

Completion Date

Sep 2010Estimated

First Submitted Date

Dec 17, 2009

First Submission Date that Met QC Criteria

Dec 17, 2009

First Posted Date

Dec 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2010

Last Update Posted Date

Mar 30, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Exercise	Behavioral	Endurance exercise 3 times weekly for 45 minutes, 4 weeks long	Exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fatigue scores on the Brief Fatigue Inventory (BFI)		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Maximal oxygen uptake (VO2max) on a treadmill stress test.		4 weeks
Scores on the HADS (Hospital Anxiety and Depression Scale)		4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Health conditions which can be aggravated by exercise

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fernando Dimeo, MD	Contact	+493084452098		fernando.dimeo@charite.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Sports Medicine	Recruiting	Berlin	State of Berlin	14167	Germany

Condition Browse Module

MeSH Terms

ID	Term
D005221	Fatigue

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise
D015928	Cognitive Behavioral Therapy

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided