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

Not Applicable

Terminated

• Conditions: Carcinoma, Non-Small-Cell Lung; Cancer of the Gastrointestinal Tract
• Interventions: Behavioral: Standard Exercise; Behavioral: Qigong Exercise

• Registration Number: NCT01374100
• Lead Sponsor: McGill University

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

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2011-04-13
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted QC: 2011-06-14
• Study First Posted: 2011-06-15
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard Exercise	Standard Exercise	See methods below - standard strength and endurance training
Qigong exercise	Standard Exercise	See methods below - medical QiGong therapy session
Standard Exercise	Qigong Exercise	See methods below - standard strength and endurance training
Qigong exercise	Qigong Exercise	See methods below - medical QiGong therapy session

Primary Outcome Measures

Name	Time	Method
Change in Depression and Anxiety	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)	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.

Secondary Outcome Measures

Name	Time	Method
Program Satisfaction	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.
Change in functional capacity	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.
Change in cancer Symptoms	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.

Trial Locations

Locations (1)

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada