A proof of concept randomised comparative study to investigate the effect of an online yoga intervention on mental health in women diagnosed with breast or gynaecological cancer - Clinical trial data
Western Sydney UniversityDataset description
HeSANDA 1.0.0Date Information
Source Study
Purpose:
Phase:
Trial acronym
Not available
Trial ID
ACTRN12620001115921
Funding
University, Western Sydney University
Scientific enquiries
Ms Maria Gonzalez
Brief Summary
The purpose of this study is to determine the effect of an online yoga exercise on mental health in women diagnosed with breast or gynaecological cancer. Who is it for? You may be eligible for this study if you are a woman aged 18 years or older, with diagnosis of breast/gynaecological cancer within the last 5 years. Study details Participants in this study arm are randomly allocated (by chance) to one of two groups: 1. 60 minute online group yoga class weekly, for 6 weeks 2. 60 minute individua .... Read more
Key Inclusion Criteria
1. Aged 18 or older 2. Ability to speak and understand English 3. Meet diagnostic criteria for an affective disorder 4. HADS scores demonstrating at least mild severity of depression or anxiety (i.e. depression or anxiety score above 7) 5. Have been diagnosed with breast/gynaecological of cancer within the last 5 years 6. Medication (including herbal medications, such as St John’s wort) and professional mental health assistance being unchanged for 3 months 7. Have adequate general health to be i .... Read more
Key Exclusion Criteria
1. Completed chemotherapy/radiotherapy (stable hormone therapy, targeted therapy or immunotherapy allowed) 2. Not taking corticosteroids 3. Serious injury or physical ailment (which yoga may negatively exacerbate), medical or psychological disorder likely to preclude completion of the trial 4. Have been undertaking yoga classes or a personal yoga practice, an average of more than once a week, over the past 3 months
Can healthy volunteers participate?
No
Population
Sample Size 28
Min. age 18 Years
Max. age No limit
Sex Females
Condition category depression , anxiety , cancer
Condition code Cancer , Mental Health
Intervention
Intervention code Lifestyle
Group yoga classes 60 minute weekly for 6 weeks. Held online via zoom by a certified yoga therapist/teacher with experience teaching people with cancer and mental health issues. Teacher and participants to use device with video, teacher will have access to large screen to visualise participants easily. Practices will be mostly standardised but there may be some individualisation according to the needs of each participant. Practices/techniques will be drawn from a Delphi study conducted by this s .... Read more
Comparison
Control group Active
Individual yoga sessions 60 minute weekly for 6 weeks. Held online via zoom by a certified yoga therapist/teacher with experience teaching people with cancer and mental health issues. Teacher and participants to use device with video, teacher will have access to large screen to visualise participants easily. Practices will be individualised to each participant. Practices/techniques will be drawn from a Delphi study conducted by this same team. Attendance will be recorded by the teacher as well a .... Read more
Outcomes
Outcome: Anxiety and depression via Hospital Anxiety and Depression Scale (composite primary outcome) Timepoint: 6 weeks post-intervention
Outcome: Feasibility. Assessed by: • The study participation rate (proportion of people accepting participation in the study) • The degree of adherence to the program (proportion of attendance to sessions) • Attrition (drop-out and withdrawal) Study deemed feasible if: at least 50% of the eligible patients consent to participate, at least 60% of the patients attend half of the yoga sessions, and 60% of patients complete at least one follow-up time point. This will be calculated .... Read more