Carcinoma, Non-Small-Cell LungNCT01374100
Effect of Qigong Therapy in Patients With Advanced Lung and Gastrointestinal Cancer Undergoing Chemotherapy
A study testing Standard Exercise and Qigong Exercise in people with Carcinoma, Non-Small-Cell Lung and Cancer of the Gastrointestinal Tract, run by McGill University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Cancer of the Gastrointestinal Tract
- What is being tested?
- Standard Exercise and Qigong Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to May 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
As per summary above
- Being tested
- Standard Exercise, Qigong Exercise
- Keywords
- Qigong, Complementary Medicine, Exercise, Traditional Chinese Medicine, Meditation, Standard Exercise, Chemotherapy, Advanced cancer, Quality of Life, Functional Assessment of Cancer Therapy, Hospital Anxiety and Depression Scale, Anxiety, Depression, Cancer Nutrition-Rehabilitation Program, Edmonton Symptom Assessment Scale, Simmonds Functional Assessment
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Gastrointestinal Neoplasms, Motor Activity, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ExerciseBehavioural
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 ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Exercise | Active comparator | See methods below - standard strength and endurance training Receives: Behavioral: Standard Exercise; Behavioral: Qigong Exercise |
| Qigong exercise | Experimental | See methods below - medical QiGong therapy session Receives: Behavioral: Standard Exercise; Behavioral: Qigong Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression and Anxiety
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.
Measured: 6 weeks
Change in Quality of Life (QoL)
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.
Measured: 6 weeks
Secondary outcomes (3)
Change in functional capacity
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.
Measured: 6 weeks
Change in cancer Symptoms
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.
Measured: 6 weeks
Program Satisfaction
Patient satisfaction will be measured by asking all participants to answer a two-item questionnaire after they have completed each 6-week exercise program.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startFeb 2009
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Slow accrual, and revised power calculation for primary end-points
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Jewish General Hospital
- Responsible party
- Principal investigator, Thomas Jagoe, McGill University
- Investigators
- Thomas Jagoe, MD, PhD, Principal investigator, McGill, Cancer Nutrition Rehabilitation Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374100
- Sponsor's protocol ID
- 08-068
- Status last verified
- Aug 2019
- First submitted
- 13 Apr 2011
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Peer-reviewed manuscripts and conference proceedings
Publications
Vanderbyl BL, Mayer MJ, Nash C, Tran AT, Windholz T, Swanson T, Kasymjanova G, Jagoe RT. A comparison of the effects of medical Qigong and standard exercise therapy on symptoms and quality of life in patients with advanced cancer. Support Care Cancer. 2017 Jun;25(6):1749-1758. doi: 10.1007/s00520-017-3579-x. Epub 2017 Jan 19.
PubMed 28102437
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Qigong Therapy in Patients With Advanced NSCLC and GI Cancer Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT01374100
- Acronym / sponsor ID
- 08-068
- Keywords
- Qigong, Complementary Medicine, Exercise, Traditional Chinese Medicine, Meditation, Standard Exercise, Chemotherapy, Advanced cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual, and revised power calculation for primary end-points
- Enrolment
- 52 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Jewish General Hospital
- Study start
- Feb 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 15 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As per summary above
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Exercise | Active comparator | Behavioral: Standard Exercise, Behavioral: Qigong ExerciseSee methods below - standard strength and endurance training |
| Qigong exercise | Experimental | Behavioral: Standard Exercise, Behavioral: Qigong ExerciseSee methods below - medical QiGong therapy session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard ExerciseThe 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. | Behavioural | Qigong exercise, Standard Exercise |
| Qigong ExerciseQigong 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. | Behavioural | Qigong exercise, Standard Exercise |
Primary outcome
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.
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.
3 secondary outcomes
Change in functional capacity
Time frame: 6 weeks
Change in cancer Symptoms
Time frame: 6 weeks
Program Satisfaction
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Slow accrual, and revised power calculation for primary end-points). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Results publication: PubMed 28102437Vanderbyl BL, Mayer MJ, Nash C, Tran AT, Windholz T, Swanson T, Kasymjanova G, Jagoe RT. A comparison of the effects of medical Qigong and standard exercise therapy on symptoms and quality of life in patients with advanced cancer. Support Care Cancer. 2017 Jun;25(6):1749-1758. doi: 10.1007/s00520-017-3579-x. Epub 2017 Jan 19.
- Individual participant dataSharing planned: Yes. Peer-reviewed manuscripts and conference proceedings
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Jagoe, MD, PhD principal investigator
McGill, Cancer Nutrition Rehabilitation Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Exercise and Qigong Exercise in people with Carcinoma, Non-Small-Cell Lung and Cancer of the Gastrointestinal Tract, run by McGill University 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 8 inclusion and 6 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: stopped early, as of the sponsor's last update on 16 Aug 2019. 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?
The study was stopped early (reason given: Slow accrual, and revised power calculation for primary end-points). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression and Anxiety (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01374100, which also lists 1 linked publication.
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 Aug 2019.