Gynaecology Exercise and Mindfulness Study (GEMS)

September 29, 2022 updated by: University of Ulster

Randomised Controlled Feasibility Trial Evaluating the Effectiveness of Mindfulness Compared to Exercise and Mindfulness on Fatigue in Women With Gynaecology Cancer

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mindfulness and exercise
This group will undertake exercise and mindfulness for 8 weeks. The home based walking and strengthening intervention is individually tailored for each participant. All exercise demonstrations, information, reporting of activity and setting of goals will take place in the app that participants will download. Additionally this group will receive a hard copy of the goal setting diary. All mindfulness information and practices are available in the app. New content will be released each week as the participants progress through the program. Participants will be phoned weekly over the 8 weeks to monitor progress.
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.
ACTIVE_COMPARATOR: Mindfulness
This group will undertake mindfulness only over 8 weeks. The mindfulness program is based on mindfulness-based stress reduction (MBSR). All information, practices and logging of the mindfulness practice will be done via the app that participants will download. Participants will be phoned weekly over the 8 weeks to monitor progress. New content will be released each week as participants progress through the program.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of eligibility and enrollment
Time Frame: 12 months
Number of eligible participants, and the proportion of those eligible that enrolled will be assessed to evaluate the feasibility of eligibility and enrollment.
12 months
Retention rate in study as feasibility
Time Frame: 8 weeks
Number and proportion of participants completing all assessments.
8 weeks
Feasibility as assessed by rate of attrition
Time Frame: 8 weeks
The number of participants dropping out after start of intervention for any reason will be assessed to evaluate attrition rate.
8 weeks
Feasibility as assessed by adherence
Time Frame: 8 weeks
Will be assessed by frequency and duration of practicing of exercise and mindfulness (recorded in a log via app).
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: Week 0 and 8
The Functional Assessment of Chronic Therapy- Fatigue (FACIT-F) subscale will be used a 13- item questionnaire that uses a 5 point Likert scale. The lower the score on this scale indicates the greater the fatigue with scores less than 20 representing severe fatigue and scores greater than 45 as normal.
Week 0 and 8
Evaluate the Quality of Life
Time Frame: Week 0 and 8
The Functional Assessment of Cancer Therapy General (FACT-G) is a 28- item rated scale. It assesses physical, social, emotional and functional wellbeing. Higher scores in this questionnaire indicate better quality of life.
Week 0 and 8
Psychological outcomes
Time Frame: Week 0 and 8
The psychological outcomes will be assessed using the Hospital Anxiety and Depression Scale (HADS). This questionnaire has 14 questions, 7 each for assessing anxiety and depression. A HADS score of greater than 11 is more defining of anxiety and depression, with a reduction of 3 points indicating a clinical improvement.
Week 0 and 8
Sleep
Time Frame: Week 0 and 8
The Pittsburgh Sleep Quality Index (PSQI) a 19 items questionnaire that measures 7 domains of sleep scored on a 0-3 scale over 1 month will be used. The questionnaire gives a score that ranges from 0-21 with the higher the score the worse the sleep quality.
Week 0 and 8
Mindfulness
Time Frame: Week 0 and 8
The 24 item Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF) is a 5 point Likert Scale which assess mindfulness in daily life. It measures 5 sub-scales: observing, describing, acting with awareness, non-judgement of inner experience and non-reacting to inner experience. The higher the score the greater the mindfulness.
Week 0 and 8
Physical activity
Time Frame: Week 0 and 8
International physical activity questionnaire (IPAQ) short form will be used to evaluate the effects on levels of activity
Week 0 and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jackie Gracey, Ulster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 14, 2022

Primary Completion (ANTICIPATED)

May 1, 2023

Study Completion (ANTICIPATED)

May 1, 2023

Study Registration Dates

First Submitted

September 20, 2022

First Submitted That Met QC Criteria

September 26, 2022

First Posted (ACTUAL)

September 30, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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