Gynaecology Exercise and Mindfulness Study

Trial Title: Gynaecology Exercise and Mindfulness Study

NCT ID: NCT05561413

Condition: Gynecologic Cancer
Uterus Cancer
Ovary Cancer
Cervical Cancer
Vaginal Cancer
Vulvar Cancer

Conditions: Official terms:
Vulvar Neoplasms
Vaginal Neoplasms
Ovarian Neoplasms
Uterine Neoplasms

Conditions: Keywords:
Neoplasms
Mindfulness
Online

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Mindfulness and exercise
Description: The mindfulness and exercise group aims to gradually increase participants exercise levels so that they begin to achieve the recommended levels along with the strengthening exercises for all major muscle groups. Along side this mindfulness will be introduced and built on to help consolidate exercise uptake and help manage symptoms experienced by the participants.
Arm group label: Mindfulness and exercise

Intervention type: Behavioral
Intervention name: Mindfulness
Description: The delivery of this practice will be through the app downloaded by participants. The practice based on mindfulness based stress reduction (MBSR). Will build on practice over the 8 weeks.
Arm group label: Mindfulness

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.

Criteria for 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)

Gender: Female

Gender based: Yes

Gender description: Participants that describe themselves as female gender eligible to participate.

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Ulster University

Address:
City: Belfast
Zip: BT1 6DN
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Jackie Gracey

Phone: +442890368284
Email: jh.gracey@ulster.ac.uk

Contact backup:
Last name: Ciara Hughes

Phone: +442871675916
Email: cm.hughes@ulster.ac.uk

Start date: June 14, 2022

Completion date: May 2023

Lead sponsor:
Agency: University of Ulster
Agency class: Other

Source: University of Ulster

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05561413