NCT01585883

Brief Summary

The purpose of this study is to investigate the suitability and practicality of a coaching and support intervention in helping patients to use daily strategies for managing breathlessness. Also, the investigators will try to understand how useful it is in helping patients to reduce intensity of breathlessness and its impact their quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable lung-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

November 30, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 26, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2015

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

4.1 years

First QC Date

April 20, 2012

Last Update Submit

May 2, 2019

Conditions

Lung CancerBreathlessness

Keywords

Lung cancerBreathlessnessSelf-management

Outcome Measures

Primary Outcomes (3)

  • Perceived severity of breathlessness

    Measured by Numeric Rating Scale for breathlessness intensity.

    8 weeks

  • Affective distress of breathlessness

    Measured by Distress of Breathlessness Numerical Rating Scale.

    8 weeks

  • Dyspnea with activities of daily living and exercise

    Measured by (a) Chronic Respiratory Questionnaire, (b) Medical Research Council Dyspnea Scale, and (c) BORG scale prior to, during, and at the end of the 6-Minute-Walk Test.

    8 weeks

Secondary Outcomes (7)

  • Self-efficacy and mastery for managing breathlessness

    8 weeks

  • Beliefs about breathlessness

    8 weeks

  • Adherence and Use of Self-Management Strategies

    8 weeks

  • Exercise capacity

    8 weeks

  • Psychological distress

    8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Self-management Intervention

EXPERIMENTAL

Individual, face-to-face 7-session self-management intervention delivered by a specialist oncology nurse/clinical case manager as a home-based approach using a manual for each session.

Behavioral: Self-management Intervention

Standard of care

ACTIVE COMPARATOR

Patients in this condition will receive usual care as decided by their oncology clinic team or physician.

Behavioral: Self-management Intervention

Interventions

Self-management InterventionBEHAVIORAL

Individual, face-to-face 7-session self-management intervention delivered by a specialist oncology nurse/clinical case manager as a home-based approach using a manual for each session. The intervention is delivered through scheduled home visits (7 sessions about one-hour in length), telephone coaching (2 sessions/week to reinforce use of strategies and for symptom monitoring: 15 minutes), and nurse moderated online peer chat or chat that is self-initiated at other times (7 weekly sessions about one hour in length).

Self-management InterventionStandard of care

Eligibility Criteria

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

You may qualify if:

  • Eligible participants are women and men with lung cancer (stage I to IV) receiving chemotherapy and/or radiotherapy
  • Report breathlessness occurrence (any score \>=3) on a Numerical Rating Scale (0-no breathlessness; 10 - worst breathlessness) during standardized routine distress screening and/or report breathlessness as a symptom to their health care provider
  • Normal cognitive function as measured by a score of \<20 on the Short Orientation Memory Cognitive Test (SOMC)
  • ECOG performance score of 0 to 2
  • Estimated life expectancy of \>3 months as per physician
  • Reside within a 45 kilometre driving radius of Princess Margaret Hospital
  • Oxygen saturation \>90% at rest on room air or with oxygen
  • Available for 8 consecutive weeks of the study.

You may not qualify if:

  • Patients who have received surgery alone as the primary treatment for lung cancer
  • Unstable acute asthma or left heart failure or coronary artery or valvular heart disease or neuromuscular disease
  • Inability to comply with the study protocol including completion of the questionnaires in English
  • Major psychiatric disorder identified by the physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital/University Health Network

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Lung NeoplasmsDyspnea

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Doris Howell, RN PhD

    Princess Margaret Hospital, University Health Network

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 20, 2012

First Posted

April 26, 2012

Study Start

November 30, 2011

Primary Completion

December 30, 2015

Study Completion

December 30, 2015

Last Updated

May 6, 2019

Record last verified: 2019-05

Locations

CA(1)