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,

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2020
INTERVENTION: 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 same team. Attendance will be recorded by the student who will be an observer at the classes for safety purposes. A weekly survey will also be completed by participants to record their adherence to classes and additional practice. CONDITION: Cancer ‐ Breast Cancer ‐ Cervical (cervix) Cancer ‐ Ovarian and primary peritoneal Cancer ‐ Womb (Uterine or endometrial cancer) depression;anxiety;cancer; ; depression ; anxiety ; cancer Mental Health ‐ Anxiety Mental Health ‐ Depression PRIMARY OUTCOME: Anxiety and depression via Hospital Anxiety and Depression Scale (composite primary outcome) [6 weeks post‐intervention] 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 by extracting the number of participants who complete the screening, consent to participate, attend the yoga sessions and complete follow up and will be calculated as a percentage of the totals.[6 weeks post‐intervention] SECONDARY OUTCOME: Acceptability: self‐report questions regarding participant perceptions of, and experiences with, the study and their respective programs. Study‐specific questionnaire eg: ; 1) Was the objective of the yoga programme clear? Strongly disagree Disagree Agree Strongly agree ; 2) Did you easily understand the programme? ; 3) Did you easily understand the tips in the yoga exercises? ; 4) Was it easy to incorporate the yoga practice in your daily life? ; 5) Were you interested in this programme? ; 6) Was this programme useful for your daily life? ; 7) Were you satisfied with this programme? ; 8) Do you wish to continue the yoga programme? ; [6 weeks post‐intervention ] Cancer Worry Scale[6 weeks post‐intervention] Depression, Anxiety and Stress Scale ‐ 21: DASS‐21 (composite outcome)[6 weeks post‐intervention] EORTC fatigue scale[6 weeks post‐intervention ] Perceived Stress Scale[6 weeks post‐intervention] Physical and mental health: PROMIS‐10. This is one composite survey that measures aspects of physical function, fatigue, pain, emotional distress, and social health.[6 weeks post‐intervention ] Quality of life: European Organization for Research and Treatment of Cancer QLQ‐C30 [6 weeks post‐intervention] 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 involved in the yoga program
Epistemonikos ID: 2531188b7c8022878389d9ff51346647d664dff4
First added on: Aug 24, 2024