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Effect of Qigong Therapy in Patients With Advanced Lung and Gastrointestinal Cancer Undergoing Chemotherapy

Primary Purpose

Carcinoma, Non-Small-Cell Lung, Cancer of the Gastrointestinal Tract

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Standard Exercise
Qigong Exercise
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Carcinoma, Non-Small-Cell Lung focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. A pathologically (histological or cytological) confirmed clinical diagnosis of non-small cell lung cancer (NSCLC) or GI cancer
  2. Stage 3 or 4 disease and eligible for anti-cancer treatment
  3. Performance status (PS) of 0 - 2 as determined by the Eastern Cooperative Oncology Group-Performance Status
  4. Life expectancy estimated at > 4 months
  5. Age 18 years or older
  6. Willing and able to provide informed consent
  7. Must be approved for participation by the oncology treatment team
  8. Able to communicate in French or English

Exclusion Criteria:

  1. Contraindication to exercise as determined by the oncology treatment team
  2. Severe cardiac or neuro-muscular/skeletal disease
  3. Engaging in interventions to address anxiety or depressive symptoms
  4. Brain metastases
  5. Active psychiatric conditions
  6. Pregnant or breast-feeding mothers

Sites / Locations

  • Jewish General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Exercise

Qigong exercise

Arm Description

See methods below - standard strength and endurance training

See methods below - medical QiGong therapy session

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 13, 2011
Last Updated
August 14, 2019
Sponsor
McGill University
Collaborators
Jewish General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01374100
Brief Title
Effect of Qigong Therapy in Patients With Advanced Lung and Gastrointestinal Cancer Undergoing Chemotherapy
Official Title
Effect of Qigong Therapy in Patients With Advanced NSCLC and GI Cancer Undergoing Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual, and revised power calculation for primary end-points
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University
Collaborators
Jewish General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung, Cancer of the Gastrointestinal Tract
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Exercise
Arm Type
Active Comparator
Arm Description
See methods below - standard strength and endurance training
Arm Title
Qigong exercise
Arm Type
Experimental
Arm Description
See methods below - medical QiGong therapy session
Intervention Type
Behavioral
Intervention Name(s)
Standard Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Qigong Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Depression and Anxiety
Description
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.
Time Frame
6 weeks
Title
Change in Quality of Life (QoL)
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in functional capacity
Description
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.
Time Frame
6 weeks
Title
Change in cancer Symptoms
Description
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.
Time Frame
6 weeks
Title
Program Satisfaction
Description
Patient satisfaction will be measured by asking all participants to answer a two-item questionnaire after they have completed each 6-week exercise program.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Jagoe, MD, PhD
Organizational Affiliation
McGill, Cancer Nutrition Rehabilitation Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
28102437
Citation
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.
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Effect of Qigong Therapy in Patients With Advanced Lung and Gastrointestinal Cancer Undergoing Chemotherapy

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