Clinical trial NCT05561413: Gynaecology Exercise and Mindfulness Study
Official title: Randomised Controlled Feasibility Trial Evaluating the Effectiveness of Mindfulness Compared to Exercise and Mindfulness on Fatigue in Women With Gynaecology Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Cancer
Uterus Cancer
Ovary Cancer
Cervical Cancer
Vaginal Cancer
Vulvar Cancer
Keywords: Neoplasms
Mindfulness
Online
Lead sponsor: University of Ulster
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 (anxiety/depression), 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with stage I-IV gynecologic cancer including endometrial, ovarian, cervical, vaginal, vulva, fallopian tube.
* Experiencing fatigue and at screening have a numerical rating score of ≥4 on a scale of 0-10.
* Ambulatory and without the use of a walking aid.
* Currently sedentary (exercising \< once a week for 20 minutes at a vigorous intensity or, two times per week for 30 minutes at moderate intensity or \< 20 minutes three times per week, for the past 6 months).

Exclusion Criteria:

* Currently actively and regularly practicing mindfulness.
* Have a confirmed diagnoses of Schizophrenia spectrum disorder, Bipolar disorder, Post-traumatic stress disorder, or risk factors for psychosis (eg personality disorder)
* Have an existing medical condition that may inhibit safe participation in the exercise part of the intervention study.
* Previously diagnosed with a fatigue-related co-morbid medical condition (i.e. Fibromyalgia, Chronic Fatigue Syndrome, Multiple Sclerosis (MS), Myalgic Encephalopathy (ME), Lupus or Arthritis)

Primary outcomes:
measure: Feasibility of eligibility and enrollment
timeFrame: 12 months
measure: Retention rate in study as feasibility
timeFrame: 8 weeks
measure: Feasibility as assessed by rate of attrition
timeFrame: 8 weeks
measure: Feasibility as assessed by adherence
timeFrame: 8 weeks
Secondary outcomes:
measure: Fatigue
timeFrame: Week 0 and 8
measure: Evaluate the Quality of Life
timeFrame: Week 0 and 8
measure: Psychological outcomes
timeFrame: Week 0 and 8
measure: Sleep
timeFrame: Week 0 and 8
measure: Mindfulness
timeFrame: Week 0 and 8
measure: Physical activity
timeFrame: Week 0 and 8
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Ulster University
state: Antrim
Study officials:
affiliation: Ulster University
name: Jackie Gracey
role: PRINCIPAL_INVESTIGATOR
References: