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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by McGill University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Jewish General Hospital
Information provided by:
McGill University
ClinicalTrials.gov Identifier:
NCT01374100
First received: April 13, 2011
Last updated: June 14, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Carcinoma, Non-Small-Cell Lung
Cancer of the Gastrointestinal Tract
Behavioral: Standard Exercise
Behavioral: Qigong Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Qigong Therapy in Patients With Advanced NSCLC and GI Cancer Undergoing Chemotherapy

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • Change in Depression and Anxiety [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Patient satisfaction will be measured by asking all participants to answer a two-item questionnaire after they have completed each 6-week exercise program.


Enrollment: 52
Study Start Date: February 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Excercise Behavioral: Standard Exercise
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.
Experimental: Qigong exercise Behavioral: Qigong Exercise
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374100

Locations
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
McGill University
Jewish General Hospital
Investigators
Principal Investigator: Thomas Jagoe, MD, PhD McGill, Cancer Nutrition Rehabilitation Program
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Thomas Jagoe, Cancer Nutrition Rehabilitation Program
ClinicalTrials.gov Identifier: NCT01374100     History of Changes
Other Study ID Numbers: 08-068
Study First Received: April 13, 2011
Last Updated: June 14, 2011
Health Authority: Canada: Institutional Review Board

Keywords provided by McGill University:
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Gastrointestinal Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 16, 2014