Gynecologic CancerGEMSNCT05561413
Gynaecology Exercise and Mindfulness Study
A study testing Mindfulness and exercise and Mindfulness in people with Gynecologic Cancer and Uterus Cancer, run by University of Ulster at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer, Uterus Cancer, Ovary Cancer
- What is being tested?
- Mindfulness and exercise and Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jun 2022to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Ulster University
Belfast, Antrim, BT1 6DN
Jackie Gracey, +442890368284, jh.gracey@ulster.ac.uk
Ciara Hughes, +442871675916, cm.hughes@ulster.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Gynecologic Cancer, Uterus Cancer, Ovary Cancer, Cervical Cancer, Vaginal Cancer, Vulvar Cancer
- Being tested
- Mindfulness and exercise, Mindfulness
- Keywords
- Neoplasms, Mindfulness, Online
- Medical subject headings
- Uterine Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness and exerciseBehavioural
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.
MindfulnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness and exercise | Experimental | 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. Receives: Behavioral: Mindfulness and exercise |
| Mindfulness | Active comparator | 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. Receives: Behavioral: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of eligibility and enrollment
Number of eligible participants, and the proportion of those eligible that enrolled will be assessed to evaluate the feasibility of eligibility and enrollment.
Measured: 12 months
Retention rate in study as feasibility
Number and proportion of participants completing all assessments.
Measured: 8 weeks
Feasibility as assessed by rate of attrition
The number of participants dropping out after start of intervention for any reason will be assessed to evaluate attrition rate.
Measured: 8 weeks
Feasibility as assessed by adherence
Will be assessed by frequency and duration of practicing of exercise and mindfulness (recorded in a log via app).
Measured: 8 weeks
Secondary outcomes (6)
Fatigue
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.
Measured: Week 0 and 8
Evaluate the Quality of Life
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.
Measured: Week 0 and 8
Psychological outcomes
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.
Measured: Week 0 and 8
Sleep
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.
Measured: Week 0 and 8
Mindfulness
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.
Measured: Week 0 and 8
Physical activity
International physical activity questionnaire (IPAQ) short form will be used to evaluate the effects on levels of activity
Measured: Week 0 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start14 Jun 2022
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jackie Gracey, Principal investigator, Ulster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561413
- Sponsor's protocol ID
- REC/21/00 76
- Acronym
- GEMS
- Status last verified
- Sep 2022
- First submitted
- 20 Sep 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McCloy K, Hughes C, Dunwoody L, Marley J, Cleland I, Cruciani F, Saunders C, Gracey J. Evaluating the effectiveness of mindfulness alone compared to exercise and mindfulness on fatigue in women with gynaecology cancer (GEMS): Protocol for a randomised feasibility trial. PLoS One. 2023 Oct 26;18(10):e0278252. doi: 10.1371/journal.pone.0278252. eCollection 2023.
PubMed 37883461
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Feasibility Trial Evaluating the Effectiveness of Mindfulness Compared to Exercise and Mindfulness on Fatigue in Women With Gynaecology Cancer
- ClinicalTrials.gov ID
- NCT05561413
- Acronym / sponsor ID
- GEMS / REC/21/00 76
- Conditions
- Gynecologic Cancer, Uterus Cancer, Ovary Cancer, Cervical Cancer, Vaginal Cancer, Vulvar Cancer
- Keywords
- Neoplasms, Mindfulness, Online
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness and exercise | Experimental | Behavioral: Mindfulness and exerciseThis 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. |
| Mindfulness | Active comparator | Behavioral: MindfulnessThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness and exerciseThe 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. | Behavioural | Mindfulness and exercise |
| MindfulnessThe 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. | Behavioural | Mindfulness |
Primary outcome
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.
Retention rate in study as feasibility
Time frame: 8 weeks
Number and proportion of participants completing all assessments.
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.
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).
6 secondary outcomes
Fatigue
Time frame: Week 0 and 8
Evaluate the Quality of Life
Time frame: Week 0 and 8
Psychological outcomes
Time frame: Week 0 and 8
Sleep
Time frame: Week 0 and 8
Mindfulness
Time frame: Week 0 and 8
Physical activity
Time frame: Week 0 and 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Derived from this study: PubMed 37883461McCloy K, Hughes C, Dunwoody L, Marley J, Cleland I, Cruciani F, Saunders C, Gracey J. Evaluating the effectiveness of mindfulness alone compared to exercise and mindfulness on fatigue in women with gynaecology cancer (GEMS): Protocol for a randomised feasibility trial. PLoS One. 2023 Oct 26;18(10):e0278252. doi: 10.1371/journal.pone.0278252. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jackie Gracey principal investigator
Ulster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and exercise and Mindfulness in people with Gynecologic Cancer and Uterus Cancer, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jackie Gracey, PhD (+442890368284, jh.gracey@ulster.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of eligibility and enrollment (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05561413, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.