Quality of Life
Conditions
Brief summary
A feasibility study to determine the appropriateness of yoga intervention to improve health-related quality of life in adult cancer patients.
Detailed description
A prospective, mixed methods feasibility trial allocated participants to receive one of three yoga interventions over a four-week study period. Data collection was completed through online survey of QOL-CA/CS and customized surveys.
Interventions
OTHERYoga
A mind-body therapy that includes specified breathing, meditation and physical postures.
Sponsors
University of British Columbia
British Columbia Cancer Agency
University of Oxford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female adult cancer patients 19 years of age or older 2. Patients receiving or planning to receive conventional treatment that includes at least one of chemotherapy, radiotherapy, hormone therapy or active surveillance within 28 days 3. Patients in any stage of cancer diagnoses of all tumour types and locations 4. Participants with internet access and willingness to participate in online communication 5. Participants with access to transportation and personal willingness to attend meetings in central Vancouver, Canada. 6. Participants fluent in the English language
Exclusion criteria
1. Patients with any physical limitation, risk of personal injury or under proscription of light to moderate physical activity 2. Patients with pre or post surgical interventions were excluded due to potential physical limitations or safety concerns with wound healing 3. Regular or experienced practitioners of yoga were excluded and defined as those patients reporting current or historical use of regular yoga (\>2 session per month in past 12 months) 4. Patients undergoing medical treatment for serious psychological disturbances that might have interfered with adherence to protocol and/or ability to provide informed consent were excluded (e.g. multiple personality disorders, severe depression, obsessive-compulsive disorder)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Patient Recruitment to Yoga Intervention | 10 weeks | Number of participants eligible for randomization to yoga intervention during cancer treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Adherence to Yoga Intervention | 6 weeks | Number of participants who completed their yoga intervention |
| Patient Adherence Rate to Yoga Intervention | 6 weeks | % of patients who completed their yoga intervention |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Acceptability of Yoga Intervention | 6 weeks | 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). |
| Financial Cost of Delivering Yoga Intervention in a Clinical Setting | 10 weeks | 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. |
| Patient's Health-related Quality of Life | 6 weeks | 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. |
Participant flow
Recruitment details
Recruitment in Vancouver, Canada commenced on April 15, 2014 via poster advertisements in Vancouver cancer clinics (n=3).
Pre-assignment details
No wash out or run-in period was allocated. Recruitment ended on June 30, 2014 and participants were randomized on July 1, 2014.
Participants by arm
| Arm | Count |
|---|---|
| Yoga Group A: Minimum Exposure 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. | 5 |
| Yoga Group B: Medium Exposure 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. | 5 |
| Yoga Group C: Maximum Exposure 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. | 5 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Yoga Group A: Minimum Exposure | Yoga Group B: Medium Exposure | Yoga Group C: Maximum Exposure | Total |
|---|---|---|---|---|
| Age, Continuous | 51.6 years | 57.2 years | 45 years | 51.3 years |
| Region of Enrollment Canada | 5 participants | 5 participants | 5 participants | 15 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 3 Participants | 11 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Stage of Cancer Diagnosis not reported | 0 participants | 1 participants | 1 participants | 2 participants |
| Stage of Cancer Diagnosis Stage I | 2 participants | 1 participants | 1 participants | 4 participants |
| Stage of Cancer Diagnosis Stage II | 2 participants | 0 participants | 1 participants | 3 participants |
| Stage of Cancer Diagnosis Stage III | 1 participants | 2 participants | 2 participants | 5 participants |
| Stage of Cancer Diagnosis Stage IV | 0 participants | 1 participants | 0 participants | 1 participants |
| Tumour Location Abdomen | 0 participants | 1 participants | 0 participants | 1 participants |
| Tumour Location Blood | 0 participants | 0 participants | 1 participants | 1 participants |
| Tumour Location Brain | 0 participants | 0 participants | 1 participants | 1 participants |
| Tumour Location Breast | 3 participants | 1 participants | 2 participants | 6 participants |
| Tumour Location Colorectal | 1 participants | 1 participants | 0 participants | 2 participants |
| Tumour Location Prostate | 0 participants | 1 participants | 1 participants | 2 participants |
| Tumour Location Skin | 0 participants | 1 participants | 0 participants | 1 participants |
| Tumour Location Tongue | 1 participants | 0 participants | 0 participants | 1 participants |
| Types of Conventional Treatment Active Surveillance | 1 participants | 2 participants | 2 participants | 5 participants |
| Types of Conventional Treatment Chemotherapy | 3 participants | 2 participants | 2 participants | 7 participants |
| Types of Conventional Treatment Hormone Therapy | 2 participants | 2 participants | 1 participants | 5 participants |
| Types of Conventional Treatment Post-surgical Intervention | 0 participants | 1 participants | 2 participants | 3 participants |
| Types of Conventional Treatment Radiotherapy | 3 participants | 3 participants | 2 participants | 8 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 5 | 0 / 4 |
Outcome results
Primary
Feasibility of Patient Recruitment to Yoga Intervention
Number of participants eligible for randomization to yoga intervention during cancer treatment
Time frame: 10 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eligible Participants | Feasibility of Patient Recruitment to Yoga Intervention | Number of participants randomized to yoga | 15 participants |
| Eligible Participants | Feasibility of Patient Recruitment to Yoga Intervention | Rate of patient recruitment per week | 1.5 participants |
Secondary
Patient Adherence Rate to Yoga Intervention
% of patients who completed their yoga intervention
Time frame: 6 weeks
Population: Male (n=4) and female (n=11) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Participants | Patient Adherence Rate to Yoga Intervention | 80 percentage of participants |
| Yoga Group B: Medium Exposure | Patient Adherence Rate to Yoga Intervention | 100 percentage of participants |
| Yoga Group C: Maximum Exposure | Patient Adherence Rate to Yoga Intervention | 80 percentage of participants |
Secondary
Patient Adherence to Yoga Intervention
Number of participants who completed their yoga intervention
Time frame: 6 weeks
Population: Male (n=4) and female (n=11) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Participants | Patient Adherence to Yoga Intervention | 4 participants |
| Yoga Group B: Medium Exposure | Patient Adherence to Yoga Intervention | 5 participants |
| Yoga Group C: Maximum Exposure | Patient Adherence to Yoga Intervention | 4 participants |
Other Pre-specified
Financial Cost of Delivering Yoga Intervention in a Clinical Setting
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.
Time frame: 10 weeks
Population: Male (n=3) and female (n=10) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible Participants | Financial Cost of Delivering Yoga Intervention in a Clinical Setting | 196 dollars (USD) |
| Yoga Group B: Medium Exposure | Financial Cost of Delivering Yoga Intervention in a Clinical Setting | 243 dollars (USD) |
| Yoga Group C: Maximum Exposure | Financial Cost of Delivering Yoga Intervention in a Clinical Setting | 360 dollars (USD) |
Other Pre-specified
Patient Acceptability of Yoga Intervention
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).
Time frame: 6 weeks
Population: Adult male (n=3) and female (n=9) cancer patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Eligible Participants | Patient Acceptability of Yoga Intervention | 6.8 units on satisfaction scale |
| Yoga Group B: Medium Exposure | Patient Acceptability of Yoga Intervention | 7 units on satisfaction scale |
| Yoga Group C: Maximum Exposure | Patient Acceptability of Yoga Intervention | 8.5 units on satisfaction scale |
Other Pre-specified
Patient's Health-related Quality of Life
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.
Time frame: 6 weeks
Population: Male (n=3) and female (n=9) adults undergoing conventional treatment for cancer diagnosis in Vancouver, Canada.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Eligible Participants | Patient's Health-related Quality of Life | Pre-intervention QOL-CA/CS | 4.88 units on quality of life scale |
| Eligible Participants | Patient's Health-related Quality of Life | Post-intervention QOL-CA/CS | 5.54 units on quality of life scale |
| Eligible Participants | Patient's Health-related Quality of Life | Mean Difference | 0.66 units on quality of life scale |
| Yoga Group B: Medium Exposure | Patient's Health-related Quality of Life | Post-intervention QOL-CA/CS | 6.06 units on quality of life scale |
| Yoga Group B: Medium Exposure | Patient's Health-related Quality of Life | Mean Difference | -0.07 units on quality of life scale |
| Yoga Group B: Medium Exposure | Patient's Health-related Quality of Life | Pre-intervention QOL-CA/CS | 6.13 units on quality of life scale |
| Yoga Group C: Maximum Exposure | Patient's Health-related Quality of Life | Mean Difference | 0.64 units on quality of life scale |
| Yoga Group C: Maximum Exposure | Patient's Health-related Quality of Life | Post-intervention QOL-CA/CS | 5.53 units on quality of life scale |
| Yoga Group C: Maximum Exposure | Patient's Health-related Quality of Life | Pre-intervention QOL-CA/CS | 5.37 units on quality of life scale |