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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Effect of Qigong Therapy in Patients With Advanced NSCLC and GI Cancer Undergoing Chemotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01374100
• Other study ID #: 08-068
• Status: Terminated
• Phase: N/A
• Start date: February 2009
• Est. completion date: May 2011

Study information

• Verified date: August 2019
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

As per summary above

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University	Jewish General Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Primary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks