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PainNCT00247832

Readiness for Discharge Following Lobectomy

A study testing Self-directed motivation and Personal motivational interviewing in people with Pain and Anxiety, run by University of British Columbia at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Anxiety
What is being tested?
Self-directed motivation and Personal motivational interviewing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteCanada
Study dates
Oct 2005to Dec 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Jennifer Rattenbury, MSc. contact

604-875-4111 ext. 62183

jrattenbury@shaw.ca

Canada1 site, 1 recruiting
  • Vancouver General Hospital Chest Centre

    Vancouver, British Columbia, V5Z 1M9

    Jennifer Rattenbury, MSc., 604-875-4111 ext. 62183, jrattenbury@shaw.ca

    John Yee, MD

    Recruiting

Other trials in Canada

About this study

Official title: Readiness for Discharge Following Lobectomy: Effects of the Thoracic Risk Intervention and Management (T.R.I.M.) Protocol

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.

Read the detailed description

There is currently little information on indicators and factors of a patient's readiness for discharge. Vancouver General Hospital is attempting to create a standardized clinical pathway for individuals who have undergone a lobectomy, to increase patient satisfaction and decrease hospital stay and complication rates. This study aims examine the relationship between the patient's readiness for discharge after lobectomy and their mobilization rate (measured as the number of steps taken in a day), frequency of visitation by family and friends, the level of anxiety and the level of pain experienced by the patient. To do this, we will test the hypotheses that a) those patients with greater mobilization and visitation rates and decreased anxiety and pain levels will have a greater self-perceived readiness for discharge and b) that patients who receive daily mobilization goals and personal motivation will have higher step rates, and therefore have a greater self-perceived readiness for discharge, than those that do not.

Ninety-nine patients will be recruited to participate in this intervention-based study. Patients will be identified by the surgeons as potential participants, and referred to the study coordinator. The study coordinator will obtain informed signed consent after the patient's physician appointment in the clinical offices. At this point, participant medical information will be collected and participants will be asked to complete the EORTC QLQ C-30 Quality of Life (QOL) questionnaire. Participants will then be randomly assigned to one of three intervention groups. The intervention groups are: G0 (no intervention), G1 (minimal intervention) and G2 (maximal intervention). Participants in the G0 group will receive the standard clinical care outlined in the present nursing clinical pathway sheets, including a pre-operative video on what to expect post-operatively. G1 participants will receive the same standard clinical care as G0 patients, but will also receive a personal ambulation goal sheet and log book to help them monitor their rate of mobility and their achievement of daily goals. G2 participants will receive the same care as G1 patients, but will also receive a daily visit from the study coordinator to help them monitor their physical activity and motivate them to achieve their goals.

Patients from all levels of intervention will fill out a questionnaire (T.R.I.M Readiness for Discharge Questionnaire, titled T.R.I.M. Participant Questionnaire when handed to participants) on their pain, anxiety and their self-perceived readiness for discharge on post-operative days 3 and 5, day of discharge and on their follow-up visit. The T.R.I.M Readiness for Discharge Questionnaire contains the Short Form - McGill Pain Questionnaire [Melzack, 1987], the Short Form State-Trait Anxiety Index [Marteau \& Bekker, 1992]. Moreover, the questionnaire asks the patient about their self-perceived readiness for discharge. They are asked to answer the question "Are you ready to go home?" by marking an X on a line (a visual analog scale, VAS) where one end of the line indicates "Not at all" and the other "Definitely". Patients will also be instructed to have their visitors sign-in and -out on a log sheet and be outfitted with a pedometer to measure the number of steps they take in a day. Also on the day of discharge, patients will be asked to fill out the EORTC Quality of Life questionnaire again. Finally, 1 month after discharge patients will be contacted for follow up and to complete the EORTC questionnaire a third time along with the Participant Questionnaire. All individuals will be visited daily by the study coordinator while they are in the hospital, who will record their daily steps. During these daily visits, the study coordinator will also examine the goals of the participants in the G2 intervention group. They will be verbally encouraged to meet their ambulation goals. Those in the G0 and G1 intervention groups will only have their daily steps recorded.

T-tests and Chi-Square analysis will be used on means and proportions respectively, to determine any differences between the intervention groups. Logistic regression analysis will be carried out and Pearson's correlation coefficients will be calculated to examine the factors that contribute to a patient's self-perceived readiness for discharge, their post-operative Quality of Life and their length of stay. Multivariate analysis of variance will be used on ambulation rates, visitation rates, pain scores, anxiety scores and readiness for discharge to examine differences between the different interventions and other factors describing the patient's clinical pathway (i.e. length of stay, days on analgesics, and hospital costs/patient).

Conditions
Pain, Anxiety
Being tested
Self-directed motivation, Personal motivational interviewing
Keywords
Monitoring, early mobilization, motivation modality, visitation rate, step rates, anxiety, pain, Elective lobectomy
Medical subject headings
Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-directed motivationBehavioural

    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.

  • Personal motivational interviewingBehavioural

    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.

Study groups in NCT00247832
Study groupRoleWhat they receive
1No interventionNot described
2ExperimentalSelf-directed motivation
Receives: Behavioral: Self-directed motivation
3ExperimentalPersonal motivational interviewing
Receives: Behavioral: Personal motivational interviewing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived readiness for discharge VAS score (at discharge)

Secondary outcomes (1)
  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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionDec 2011 (estimated)
  4. Study completionDec 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
99 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00247832
Sponsor's protocol ID
C05 - 0500
Status last verified
Nov 2011
First submitted
31 Oct 2005
Last updated
16 Nov 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Self-directed motivation and Personal motivational interviewing in people with Pain and Anxiety, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jennifer Rattenbury, MSc. (604-875-4111 ext. 62183, jrattenbury@shaw.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived readiness for discharge VAS score (at discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2011; AzTrials last refreshed its copy on 1 Nov 2026.

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