NCT01374100

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2011

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

2.2 years

First QC Date

April 13, 2011

Last Update Submit

August 14, 2019

Conditions

Carcinoma, Non-Small-Cell LungCancer of the Gastrointestinal Tract

Keywords

QigongComplementary MedicineExerciseTraditional Chinese MedicineMeditationStandard ExerciseChemotherapyAdvanced cancerQuality of LifeFunctional Assessment of Cancer TherapyHospital Anxiety and Depression ScaleAnxietyDepressionCancer Nutrition-Rehabilitation ProgramEdmonton Symptom Assessment ScaleSimmonds Functional Assessment

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Change in functional capacity

    6 weeks

  • Change in cancer Symptoms

    6 weeks

  • Program Satisfaction

    6 weeks

Study Arms (2)

Standard Exercise

ACTIVE COMPARATOR

See methods below - standard strength and endurance training

Behavioral: Standard ExerciseBehavioral: Qigong Exercise

Qigong exercise

EXPERIMENTAL

See methods below - medical QiGong therapy session

Behavioral: Standard ExerciseBehavioral: Qigong Exercise

Interventions

Standard ExerciseBEHAVIORAL

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 exerciseStandard Exercise
Qigong ExerciseBEHAVIORAL

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.

Qigong exerciseStandard Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related 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. 2017 Jun;25(6):1749-1758. doi: 10.1007/s00520-017-3579-x. Epub 2017 Jan 19.

    PMID: 28102437RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungGastrointestinal NeoplasmsMotor ActivityDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesBehaviorBehavioral SymptomsMental Disorders

Study Officials

  • Thomas Jagoe, MD, PhD

    McGill, Cancer Nutrition Rehabilitation Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

April 13, 2011

First Posted

June 15, 2011

Study Start

February 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

August 16, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

Peer-reviewed manuscripts and conference proceedings

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
All group data already supplied in published manuscript
Access Criteria
Other specific anonymized data on participants supplied for academic/research purposes by application to the senior author.

Locations

CA(1)