- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01374100
Effect of Qigong Therapy in Patients With Advanced Lung and Gastrointestinal Cancer Undergoing Chemotherapy
August 14, 2019 updated by: Thomas Jagoe, McGill University
Effect of Qigong Therapy in Patients With Advanced NSCLC and GI Cancer Undergoing Chemotherapy
Cancer patients face a number of symptoms related to treatment or disease which may impair quality of life, such as decreased functional capacity, fatigue, nausea an vomiting, distress, depression and unmet psychological needs.
Due to this array of symptoms, cancer patients often seek supportive complementary and alternative medicine, which many patients use along with conventional treatments.
Qigong, a type traditional chinese medicine, is a mind-body exercise that combines meditation, slow physical movements, and controlled breathing.
The investigators hypothesise that Qigong therapy is better in the reduction of anxiety and depression levels and the improvement of quality of life in patients with lung and gastrointestinal (GI) cancer who are eligible for anti-cancer treatment, when compared to standard exercise training.
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
As per summary above
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A pathologically (histological or cytological) confirmed clinical diagnosis of non-small cell lung cancer (NSCLC) or GI cancer
- Stage 3 or 4 disease and eligible for anti-cancer treatment
- Performance status (PS) of 0 - 2 as determined by the Eastern Cooperative Oncology Group-Performance Status
- Life expectancy estimated at > 4 months
- Age 18 years or older
- Willing and able to provide informed consent
- Must be approved for participation by the oncology treatment team
- Able to communicate in French or English
Exclusion Criteria:
- Contraindication to exercise as determined by the oncology treatment team
- Severe cardiac or neuro-muscular/skeletal disease
- Engaging in interventions to address anxiety or depressive symptoms
- Brain metastases
- Active psychiatric conditions
- Pregnant or breast-feeding mothers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Standard Exercise
See methods below - standard strength and endurance training
|
The standard exercise therapy program will include 12 treatments of approximately 45 minutes duration, twice a week for a period of six weeks by the same instructor and at the same location as for Qigong therapy.
This exercise program is supervised and consists of cardio-vascular and resistance training exercises.
Participants are asked to refrain from practicing Qigong during this 6 week period.
Qigong therapy will be led by a trained Qigong instructor and will occur for 45 minutes sessions, twice a week for a period of six weeks.
Qigong is a self-directed walking exercise program that involves arm movements that are coordinated with slight movements of the waist, while in a state of deep relaxation or meditation.
Patients will be asked to refrain from independent resistance or cardiovascular training during this 6 week period.
|
EXPERIMENTAL: Qigong exercise
See methods below - medical QiGong therapy session
|
The standard exercise therapy program will include 12 treatments of approximately 45 minutes duration, twice a week for a period of six weeks by the same instructor and at the same location as for Qigong therapy.
This exercise program is supervised and consists of cardio-vascular and resistance training exercises.
Participants are asked to refrain from practicing Qigong during this 6 week period.
Qigong therapy will be led by a trained Qigong instructor and will occur for 45 minutes sessions, twice a week for a period of six weeks.
Qigong is a self-directed walking exercise program that involves arm movements that are coordinated with slight movements of the waist, while in a state of deep relaxation or meditation.
Patients will be asked to refrain from independent resistance or cardiovascular training during this 6 week period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Depression and Anxiety
Time Frame: 6 weeks
|
Depression and anxiety will be measured using the Hospital Anxiety Depression Scale (HADS); The HADS is a 14-item self-rated questionnaire, consisting of two 7-item subscales.
It was developed to identify anxiety and depression in non-psychiatric medical outpatients.
Each item on the HADS is scored from 0 (no problem) to 3 (maximum distress).
The HADS will be administered within 2 weeks of completing each exercise program.
|
6 weeks
|
Change in Quality of Life (QoL)
Time Frame: 6 weeks
|
The general version of the Functional Assessment of Cancer Therapy scale (FACT-G) will be used to measure Quality of Life (QoL) after completion of each 6 week exercise program.
This questionnaire consists of 4 subscales: Physical well-being (PWB), Social well-being (SWB), Emotional well-being (EWB) and Functional well-being (FWB).
A change of 4 points on the total FACT score is regarded as clinically significant.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in functional capacity
Time Frame: 6 weeks
|
Functional capcity will be measured using the Simmonds Functional Assessment (SFA) within 2 weeks of finishing each 6-week exercise program.
This tool consists of eight items: putting on a sock, tying a belt, putting coins in a cup, reaching forward, repeated reach up (3 times), repeated sit to stand (2 times), speed walk for 50 feet, and walking for 6 minutes.
Patient satisfaction will be measured by asking all participants to answer a two item questionnaire with a 10-point visual analog scale response option.
|
6 weeks
|
Change in cancer Symptoms
Time Frame: 6 weeks
|
Symptoms commonly reported by lung and GI cancer patients will be measured using the Edmonton Symptom Assessment Scale (ESAS).
The ESAS is a 12-item patient rated symptom questionnaire scored using a 10-point visual analogue scale.
The ESAS will be administered within 2 weeks of completing each 6-week exercise program.
|
6 weeks
|
Program Satisfaction
Time Frame: 6 weeks
|
Patient satisfaction will be measured by asking all participants to answer a two-item questionnaire after they have completed each 6-week exercise program.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas Jagoe, MD, PhD, McGill, Cancer Nutrition Rehabilitation Program
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (ACTUAL)
May 1, 2011
Study Completion (ACTUAL)
May 1, 2011
Study Registration Dates
First Submitted
April 13, 2011
First Submitted That Met QC Criteria
June 14, 2011
First Posted (ESTIMATE)
June 15, 2011
Study Record Updates
Last Update Posted (ACTUAL)
August 16, 2019
Last Update Submitted That Met QC Criteria
August 14, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
- Depression
- Exercise
- Quality of Life
- Anxiety
- Hospital Anxiety and Depression Scale
- Advanced cancer
- Meditation
- Chemotherapy
- Traditional Chinese Medicine
- Complementary Medicine
- Qigong
- Edmonton Symptom Assessment Scale
- Standard Exercise
- Functional Assessment of Cancer Therapy
- Cancer Nutrition-Rehabilitation Program
- Simmonds Functional Assessment
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Gastrointestinal Neoplasms
Other Study ID Numbers
- 08-068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Peer-reviewed manuscripts and conference proceedings
IPD Sharing Time Frame
All group data already supplied in published manuscript
IPD Sharing Access Criteria
Other specific anonymized data on participants supplied for academic/research purposes by application to the senior author.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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