NCT00181129

Brief Summary

The purpose of this randomized controlled trial is to determine the effects of a nurse-directed, home-based walking exercise program to mitigate fatigue and maintain physical functioning during adjuvant therapy for cancer. The sample will be randomized into exercise (EX) or usual care (UC) groups. The independent study variable is participation in a walking exercise program. Outcomes include: fatigue, sleep disturbance, emotional distress, physical functioning and quality of life. The effects of the walking exercise program will be evaluated using self-report questionnaires administered pre- and post-treatment, patient diaries, and symptoms assessments at defined intervals during adjuvant therapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Sep 2002

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

5.7 years

First QC Date

September 12, 2005

Last Update Submit

December 19, 2018

Conditions

CancerFatigue

Keywords

FatigueCancer treatment

Interventions

home based self paced walking programBEHAVIORAL

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of cancer (Stage 1,2,or 3),
  • years of age or older,
  • Free of cognitive or physical deficits that would preclude entry into study,
  • not currently exercising 120 min/wk or more

You may not qualify if:

  • Concurrent major health problems or disabilities that would limit participation in an exercise program.
  • Stage 4 cancer (metastisis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University School of Nursing

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

NeoplasmsFatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Victoria L Mock, DNSc

    Johns Hopkins University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

September 1, 2002

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

December 20, 2018

Record last verified: 2018-12

Locations

US(1)