NCT00247832

Brief Summary

This study aims to examine the relationship between the patient's perception of readiness for discharge after lobectomy and mobilization rates, frequency of visitation by family and friends, anxiety levels and pain levels. We will test the hypotheses that a) those patients who walk farther early after surgery and who have more visitors and decreased anxiety and pain levels will have a greater self-perceived readiness for discharge and b) that patients who receive daily ambulation goals and personal motivation will have higher step rates, and therefore have a greater self-perceived readiness for discharge, than those that do not. We will monitor patients, during the post-operative recovery period using pedometers to count steps taken, visitor log sheets, and questionnaires on the patients' anxiety, pain and perceived readiness for discharge. Furthermore, we will examine how the patient's self-perceived readiness for discharge is affected by study interventions which include ambulation goals and daily personal motivation.

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
99

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable pain

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

October 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2005

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 16, 2011

Status Verified

November 1, 2011

Enrollment Period

6.2 years

First QC Date

October 31, 2005

Last Update Submit

November 15, 2011

Conditions

Keywords

Monitoring, early mobilization, motivation modality, visitation rate, step rates, anxiety, painElective lobectomy

Outcome Measures

Primary Outcomes (1)

  • Perceived readiness for discharge VAS score (at discharge)

Secondary Outcomes (1)

  • Length of stay, physician's and nurses perceived readiness for discharge, visitation rates, anxiety score, pain score (at discharge), primary and secondary outcomes (at post-op days 3, 5 and follow-up)

Study Arms (3)

1

NO INTERVENTION

2

EXPERIMENTAL

Self-directed motivation

Behavioral: Self-directed motivation

3

EXPERIMENTAL

Personal motivational interviewing

Behavioral: Personal motivational interviewing

Interventions

Post-lobectomy patients are provided with a booklet that outlines expected physical activities (sitting up, walking arm exercises) to aim for each day after surgery. It also provides room for the patients to record what they have accomplished.

2

Post-lobectomy patients receive daily visits from a study coordinator aimed to motivate the patient to complete various physical activities each day after surgery. The study coordinator goes through the same booklet that is given to Group 2 and helps patients set goals and record their accomplishments.

3

Eligibility Criteria

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

You may qualify if:

  • Undergoing elective lobectomy,
  • speak, write and read English,
  • ambulate prior to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital Chest Centre

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • John Yee, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Rattenbury, MSc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2005

First Posted

November 2, 2005

Study Start

October 1, 2005

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 16, 2011

Record last verified: 2011-11

Locations