Yoga in Adult Cancer: A Feasibility Trial (Y-ACT)

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

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

Study Overview

• Status: Completed
• Conditions: Quality of Life
• Intervention / Treatment: Other: Yoga

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yoga Group A: Minimum Exposure; The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. In Week 1, 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.	Other: Yoga; A mind-body therapy that includes specified breathing, meditation and physical postures.
Experimental: Yoga Group B: Medium Exposure; The medium-exposure yoga package, this intervention included 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 1. Participants were then 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 (Weeks 1 to 4). 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.	Other: Yoga; A mind-body therapy that includes specified breathing, meditation and physical postures.
Experimental: 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 1. 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 (Weeks 1 to 4). 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.	Other: Yoga; A mind-body therapy that includes specified breathing, meditation and physical postures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Patient Recruitment to Yoga Intervention	Number of participants eligible for randomization to yoga intervention during cancer treatment	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Adherence to Yoga Intervention	Number of participants who completed their yoga intervention	6 weeks
Patient Adherence Rate to Yoga Intervention	% of patients who completed their yoga intervention	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: University of British Columbia; British Columbia Cancer Agency
• Investigators: Principal Investigator: Melanie McDonald, MSW, Vancouver-BCCA

Publications and helpful links

General Publications

• McCall M, McDonald M, Thorne S, Ward A, Heneghan C. Yoga for Health-Related Quality of Life in Adult Cancer: A Randomized Controlled Feasibility Study. Evid Based Complement Alternat Med. 2015;2015:816820. doi: 10.1155/2015/816820. Epub 2015 Jun 11.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: November 21, 2014
• First Submitted That Met QC Criteria: December 2, 2014
• First Posted (Estimate): December 5, 2014

Study Record Updates

• Last Update Posted (Estimate): February 10, 2015
• Last Update Submitted That Met QC Criteria: February 9, 2015
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: OXTREC 534-14