Self-Management Intervention for Breathlessness in Lung Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Lung Cancer Breathlessness |
Behavioral: Self-management Intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Pilot Trial of a Self-Management Intervention for Breathlessness in Lung Cancer |
- Perceived severity of breathlessness [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Measured by Numeric Rating Scale for breathlessness intensity.
- Affective distress of breathlessness [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Measured by Distress of Breathlessness Numerical Rating Scale.
- Dyspnea with activities of daily living and exercise [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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.
- Self-efficacy and mastery for managing breathlessness [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Measured by (a) individual self-report items for "self-efficacy for managing shortness of breath" and "self-efficacy for exercise" from the toolkit of Stanford measures; (b) Chronic Respiratory Questionnaire - Mastery subscale; (c) adapted COPD Self-Efficacy Scale developed for this study.
- Beliefs about breathlessness [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Measured by Symptom Representation Questionnaire.
- Adherence and Use of Self-Management Strategies [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Measured using (1) Daily activity log of physical activity;(2)Seven-Day Physical Activity Recall tool (7-day PAR);(3) Cognitive Symptom Management Scale;(4) Daily tracking log of self-management strategies
- Exercise capacity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Measured by 6-Minute Walk Test.
- Psychological distress [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Measured by the Hospital Anxiety and Depression Scale.
- Quality of life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Measured by (a) Functional Assessment of Cancer Therapy - Lung (FACT-L); and, (b)Chronic Respiratory Questionnaire.
- Health care utilization [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Measured by three questions derived from the Stanford Self-Management Program Toolkit of Measures, regarding number of hospital days, emergency room visits, and visits to physicians related to their breathlessness.
| Estimated Enrollment: | 56 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Self-management Intervention
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
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).
|
|
Active Comparator: Standard of care
Patients in this condition will receive usual care as decided by their oncology clinic team or physician.
|
Behavioral: Self-management Intervention
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).
|
Detailed Description:
Lung cancer is common worldwide and is a leading cause of death. Breathlessness (dyspnea or shortness of breath) is a highly prevalent clinical problem in lung cancer, developing early in 25-50% of patients due to advanced stage at presentation. It persists in 60% of survivors' post-lung resection and worsens with progressive disease with rates as high as 90% reported in the final months of life. Breathlessness is associated with a high degree of unpleasantness, negatively impacts on daily functioning, and multiple domains of quality of life, triggers fear and anxiety in patients and their family, and contributes to symptom specific and psychological distress. It is also costly to the health system as it contributes to urgent care use and hospitalization. The purpose of this pilot trial is to evaluate feasibility and acceptability of a self-management intervention for breathlessness in lung cancer.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
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.
Exclusion criteria:
- 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.
Contacts and Locations| Contact: Samantha Mayo | 416-340-4800 ext 5605 | smayo@uhnresearch.ca |
| Contact: Doris Howell | 416-946-4501 ext 3419 | doris.howell@uhn.ca |
| Canada, Ontario | |
| Princess Margaret Hospital/University Health Network | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Samantha Mayo 416-340-4800 ext 5605 smayo@uhnresearch.ca | |
| Principal Investigator: | Doris Howell, RN PhD | Princess Margaret Hospital, University Health Network |
More Information
No publications provided
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT01585883 History of Changes |
| Other Study ID Numbers: | Breathlessness Pilot |
| Study First Received: | April 20, 2012 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University Health Network, Toronto:
|
Lung cancer Breathlessness Self-management |
Additional relevant MeSH terms:
|
Dyspnea Lung Neoplasms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
ClinicalTrials.gov processed this record on May 21, 2013