Clinical trial NCT03084692: Therapeutic Yoga and Resistance Exercise for Lung Cancer
Official title: Feasibility and Preliminary Efficacy of a Combined Therapeutic Yoga and Resistance Exercise Intervention for Individuals With Lung Cancer and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: caregiver
lung cancer
yoga
resistance exercise
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single group before and after intervention study design will be used for this pilot feasibility trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to determine the feasibility and preliminary efficacy of a combined therapeutic yoga and resistance exercise intervention for individuals with lung cancer and their caregivers. The investigators aim is to help reduce the fear of exercise by tailoring the program to meet the specific needs of the survivor with lung cancer. The investigators want to see whether individuals with lung cancer and their caregivers are interested in participating in this type of program, and if they are able to attend the intervention sessions and complete the program. The investigators also plan to study the preliminary effects of therapeutic yoga and resistance exercise on fitness outcomes for both individuals with lung cancer and their caregivers.

Detailed description: To determine the feasibility of a combined therapeutic yoga and resistance exercise intervention for lung cancer survivors and their caregivers. A single group before and after intervention study design will be used for this pilot feasibility trial. Brochures and information about the study will be distributed at the Cross Cancer Institute, and interested individuals will be screened for eligibility. A convenient sampling technique will be used to recruit individuals with lung cancer and their caregiver. Participants deemed eligible to take part in the study will provide written informed consent to participate in the study and will undergo baseline testing. The intervention will be carried out over a period of 8 weeks. The feasibility outcomes will include eligibility rate, completion rate, adherence rate and adverse events. Dyspnea will be the primary self-reported outcome to be measured for individuals with lung cancer. The secondary outcomes will include fatigue, shoulder range of motion, chest expansion, and muscular strength. The outcome measures for the caregivers will include quality of life (QoL) and muscular strength.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Primary Lung Cancer Stage I-IV (all stages)
2. Any form of Lung cancer included: Small Cell Lung Cancer and Non-Small Cell Lung Cancer
3. Age: 18 years or above
4. Patients at any time point during treatment: ongoing treatment, completed treatment or recently diagnosed and about to start treatment
5. Karnofsky Performance Status ≥ 50 (Appendix A)
6. Life expectancy at least one year -

Exclusion Criteria:

1. Metastatic lung disease that would preclude safe exercise prescription
2. Secondary Lung cancer due to metastasis from other parts of body
3. Co-morbid conditions such as diabetes, congestive heart failure, dementia, cerebrovascular diseases.
4. Individuals who would be unsafe to participate in an intervention program.
5. Unable to provide consent in English
6. Unable to complete either testing or intervention components (e.g. extended holiday)

Caregiver eligibility: Caregivers will be screened using the PAR-Q + questionnaire and will be required to obtain approval from a family physician should any safety concerns be identified.

Primary outcomes:
measure: Completion Rate
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Dyspnoea Visual Analogue Scale
timeFrame: 8 weeks
measure: Dyspnoea-12
timeFrame: 8 weeks
measure: Functional Assessment of Cancer Therapy: Fatigue Scale (FACT-F)
timeFrame: 8 weeks
measure: Chest expansion (centimetres)
timeFrame: 8 weeks
measure: Shoulder Range of Motion (degrees)
timeFrame: 8 weeks
measure: Muscular strength
timeFrame: 8 weeks
measure: Pulmonary Function Testing
timeFrame: 8 weeks
measure: CareGiver Oncology Quality of Life (CarGOQoL) questionnaire (Caregivers only)
timeFrame: 8 weeks
measure: Chalder Fatigue Scale (Caregivers only)
timeFrame: 8 weeks
measure: Adherence Rate
timeFrame: up to 8 weeks
measure: Recruitment rate
timeFrame: 24 weeks
measure: Adverse Event
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta/ Cross Cancer Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Margaret McNeely
role: PRINCIPAL_INVESTIGATOR
References: