Ignite Creation Date:
2024-05-06 @ 6:09 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05561413
Status:
UNKNOWN
Last Update Posted:
2022-10-03
First Post:
2022-09-20
Brief Title:
Gynaecology Exercise and Mindfulness Study
Sponsor:
University of Ulster
Organization:
University of Ulster
Study Overview
Official Title:
Randomised Controlled Feasibility Trial Evaluating the Effectiveness of Mindfulness Compared to Exercise and Mindfulness on Fatigue in Women With Gynaecology Cancer
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEMS
Brief Summary:
The aim of this study is to explore the feasibility and effectiveness of conducting a mindfulness and home-based walking and strength training program on fatigue psychological outcomes and quality of life for gynecological cancer survivors The intervention consists of a 8 week mindfulness and home based walking and strengthening program for gynecology survivors It will be delivered through a specifically designed app The aim would be to gradually increase exercise and mindfulness levels so participants start to achieve the recommended levels of activity per week
Participants will be recruited via cancer Charites and their service users either directly and through social media Facebook Instagram Twitter Both groups will receive an intervention either mindfulness alone or mindfulness and exercise Assessments will be taken at baseline 0 weeks and post intervention 8 weeks Both groups will complete the same assessments at the same time-points
Participants will be recruited via cancer Charites and their service users either directly and through social media Facebook Instagram Twitter Both groups will receive an intervention either mindfulness alone or mindfulness and exercise Assessments will be taken at baseline 0 weeks and post intervention 8 weeks Both groups will complete the same assessments at the same time-points
Detailed Description:
Treatment modalities can be effective in managing and treating gynecology cancers but may lead to unwanted long term side effects Some of which include fatigue changes in mood and sleep disturbance All of which can have an effect on quality of life Both exercise and mindfulness would appear to show a positive effect on managing some of these symptoms However not only does ambiguity continue around the effect of these interventions on symptoms of cancer but continues to be a lack of evidence for certain types of cancer such as gynecology Furthermore combining interventions that individually are effective may enhance effectiveness when used together and the delivering these online may reach a wider population The evidence for this is also lacking within the literature Therefore this study aims to assess the feasibility of delivering these interventions through an online platform to assess not only the acceptability but also effect on clinical outcomes
Participants will be recruited through contact via cancer charities and online Social media they will self refer to the team and will be assessed for eligibility If eligible and interested participant information sheet will be sent electronically and time given one week to consider study Contact will be made with participant after this time and if interested a link to electronic consent will be sent On receiving the completed consent another link will be sent to participant for completion of baseline outcome measures The outcome measures assessed include feasibility fatigue physical activity level mood anxietydepression sleep quality of life and mindfulness Following randomization both groups will be given instructions on how to download app and reporting of activity Both groups will be contacted through weekly phone calls to monitor their progress Once 8 weeks have been completed a link will be sent to participants to complete the post-intervention outcome measures
Participants will be recruited through contact via cancer charities and online Social media they will self refer to the team and will be assessed for eligibility If eligible and interested participant information sheet will be sent electronically and time given one week to consider study Contact will be made with participant after this time and if interested a link to electronic consent will be sent On receiving the completed consent another link will be sent to participant for completion of baseline outcome measures The outcome measures assessed include feasibility fatigue physical activity level mood anxietydepression sleep quality of life and mindfulness Following randomization both groups will be given instructions on how to download app and reporting of activity Both groups will be contacted through weekly phone calls to monitor their progress Once 8 weeks have been completed a link will be sent to participants to complete the post-intervention outcome measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None