Yoga in Adult Cancer: A Feasibility Trial

Quality of Life Clinical Trial

— Y-ACT  

Official title:

Yoga for Health-related Quality of Life in Adult Cancer: A Randomized Controlled Feasibility Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02309112
• Other study ID #: OXTREC 534-14
• Status: Completed
• Phase: N/A
• First received: November 21, 2014
• Last updated: February 9, 2015
• Start date: April 2014
• Est. completion date: August 2014

Study information

• Verified date: November 2014
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

A feasibility study to determine the appropriateness of yoga intervention to improve health-related quality of life in adult cancer patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Quality of Life

Intervention

Other:
• Yoga
A mind-body therapy that includes specified breathing, meditation and physical postures.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	British Columbia Cancer Agency, University of British Columbia

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	6 weeks	No
Other	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.	10 weeks	No
Other	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.	6 weeks	No
Primary	Feasibility of Patient Recruitment to Yoga Intervention	Number of participants eligible for randomization to yoga intervention during cancer treatment	10 weeks	No
Secondary	Patient Adherence to Yoga Intervention	Number of participants who completed their yoga intervention	6 weeks	No
Secondary	Patient Adherence Rate to Yoga Intervention	% of patients who completed their yoga intervention	6 weeks	No