Trial Outcomes & Findings for Yoga in Adult Cancer: A Feasibility Trial (NCT NCT02309112)
NCT ID: NCT02309112
Last Updated: 2015-02-10
Results Overview
Number of participants eligible for randomization to yoga intervention during cancer treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
10 weeks
Results posted on
2015-02-10
Participant Flow
Recruitment in Vancouver, Canada commenced on April 15, 2014 via poster advertisements in Vancouver cancer clinics (n=3).
No wash out or run-in period was allocated. Recruitment ended on June 30, 2014 and participants were randomized on July 1, 2014.
Participant milestones
| Measure |
Yoga Group A
The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class.
Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures.
|
Yoga Group B
The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3.
Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures.
|
Yoga Group C
The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient.
Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
|
Overall Study
Completed Yoga Intervention
|
4
|
5
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Yoga Group A
The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class.
Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures.
|
Yoga Group B
The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3.
Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures.
|
Yoga Group C
The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient.
Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Yoga in Adult Cancer: A Feasibility Trial
Baseline characteristics by cohort
| Measure |
Yoga Group A: Minimum Exposure
n=5 Participants
The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class.
Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures.
|
Yoga Group B: Medium Exposure
n=5 Participants
The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3.
Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures.
|
Yoga Group C: Maximum Exposure
n=5 Participants
The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient.
Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.6 years
n=5 Participants
|
57.2 years
n=7 Participants
|
45 years
n=5 Participants
|
51.3 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Tumour Location
Breast
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Tumour Location
Prostate
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Tumour Location
Colorectal
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Tumour Location
Blood
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Tumour Location
Skin
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Tumour Location
Abdomen
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Tumour Location
Tongue
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Tumour Location
Brain
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Stage of Cancer Diagnosis
Stage I
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Stage of Cancer Diagnosis
Stage II
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Stage of Cancer Diagnosis
Stage III
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Stage of Cancer Diagnosis
Stage IV
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Stage of Cancer Diagnosis
not reported
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Types of Conventional Treatment
Chemotherapy
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Types of Conventional Treatment
Radiotherapy
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Types of Conventional Treatment
Hormone Therapy
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Types of Conventional Treatment
Active Surveillance
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Types of Conventional Treatment
Post-surgical Intervention
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: Male (n=4) and female (n=11) adult patients undergoing conventional treatment in Vancouver, Canada for a cancer diagnosis; who have not participated in yoga the past month.
Number of participants eligible for randomization to yoga intervention during cancer treatment
Outcome measures
| Measure |
Eligible Participants
n=15 Participants
The group of eligible participants who agreed to be randomized to ono of three yoga groups.
|
Yoga Group B: Medium Exposure
Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
|
Yoga Group C: Maximum Exposure
Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
|
|---|---|---|---|
|
Feasibility of Patient Recruitment to Yoga Intervention
Number of participants randomized to yoga
|
15 participants
|
—
|
—
|
|
Feasibility of Patient Recruitment to Yoga Intervention
Rate of patient recruitment per week
|
1.5 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Male (n=4) and female (n=11) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada
Number of participants who completed their yoga intervention
Outcome measures
| Measure |
Eligible Participants
n=5 Participants
The group of eligible participants who agreed to be randomized to ono of three yoga groups.
|
Yoga Group B: Medium Exposure
n=5 Participants
Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
|
Yoga Group C: Maximum Exposure
n=5 Participants
Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
|
|---|---|---|---|
|
Patient Adherence to Yoga Intervention
|
4 participants
|
5 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Male (n=4) and female (n=11) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada
% of patients who completed their yoga intervention
Outcome measures
| Measure |
Eligible Participants
n=5 Participants
The group of eligible participants who agreed to be randomized to ono of three yoga groups.
|
Yoga Group B: Medium Exposure
n=5 Participants
Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
|
Yoga Group C: Maximum Exposure
n=5 Participants
Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
|
|---|---|---|---|
|
Patient Adherence Rate to Yoga Intervention
|
80 percentage of participants
|
100 percentage of participants
|
80 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksPopulation: Adult male (n=3) and female (n=9) cancer patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada
Amount of satisfaction for adult cancer patients assessed via Likert-scale surveys; on scale of 1 to 10, 1 being not satisfied; 10 being extremely satisfied (i.e higher number, better outcome).
Outcome measures
| Measure |
Eligible Participants
n=4 Participants
The group of eligible participants who agreed to be randomized to ono of three yoga groups.
|
Yoga Group B: Medium Exposure
n=4 Participants
Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
|
Yoga Group C: Maximum Exposure
n=4 Participants
Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
|
|---|---|---|---|
|
Patient Acceptability of Yoga Intervention
|
6.8 units on satisfaction scale
Interval 1.0 to 10.0
|
7 units on satisfaction scale
Interval 5.0 to 8.0
|
8.5 units on satisfaction scale
Interval 6.0 to 10.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 weeksPopulation: Male (n=3) and female (n=10) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada
Calculation of the per participant cost of three types of yoga interventions (Group A, B and C). The financial data included cost of in-person instruction, cost of materials and time to design and implement intervention per participant in each yoga group.
Outcome measures
| Measure |
Eligible Participants
n=4 Participants
The group of eligible participants who agreed to be randomized to ono of three yoga groups.
|
Yoga Group B: Medium Exposure
n=5 Participants
Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
|
Yoga Group C: Maximum Exposure
n=4 Participants
Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
|
|---|---|---|---|
|
Financial Cost of Delivering Yoga Intervention in a Clinical Setting
|
196 dollars (USD)
|
243 dollars (USD)
|
360 dollars (USD)
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksPopulation: Male (n=3) and female (n=9) adults undergoing conventional treatment for cancer diagnosis in Vancouver, Canada.
Assessed via an online survey of a validated, cancer-specific survey instrument measuring health-related quality of life (QOL-CA/CS), (0 worst; 10 best possible). The QOL-CA/CS score was assessed pre and post yoga intervention.
Outcome measures
| Measure |
Eligible Participants
n=4 Participants
The group of eligible participants who agreed to be randomized to ono of three yoga groups.
|
Yoga Group B: Medium Exposure
n=4 Participants
Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
|
Yoga Group C: Maximum Exposure
n=4 Participants
Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
|
|---|---|---|---|
|
Patient's Health-related Quality of Life
Pre-intervention QOL-CA/CS
|
4.88 units on quality of life scale
Interval 3.51 to 6.05
|
6.13 units on quality of life scale
Interval 5.13 to 7.9
|
5.37 units on quality of life scale
Interval 3.78 to 6.88
|
|
Patient's Health-related Quality of Life
Post-intervention QOL-CA/CS
|
5.54 units on quality of life scale
Interval 2.76 to 8.0
|
6.06 units on quality of life scale
Interval 4.73 to 7.25
|
5.53 units on quality of life scale
Interval 3.78 to 7.13
|
|
Patient's Health-related Quality of Life
Mean Difference
|
0.66 units on quality of life scale
Interval -0.75 to 2.24
|
-0.07 units on quality of life scale
Interval -0.65 to 1.08
|
0.64 units on quality of life scale
Interval -0.24 to 0.85
|
Adverse Events
Yoga Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Yoga Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Yoga Group C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place