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Gynaecology Exercise and Mindfulness Study (GEMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05561413
Recruitment Status : Recruiting
First Posted : September 30, 2022
Last Update Posted : October 3, 2022
Sponsor:
Information provided by (Responsible Party):
University of Ulster

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.


Condition or disease Intervention/treatment Phase
Gynecologic Cancer Uterus Cancer Ovary Cancer Cervical Cancer Vaginal Cancer Vulvar Cancer Behavioral: Mindfulness and exercise Behavioral: Mindfulness Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomised Controlled Feasibility Trial Evaluating the Effectiveness of Mindfulness Compared to Exercise and Mindfulness on Fatigue in Women With Gynaecology Cancer
Actual Study Start Date : June 14, 2022
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023


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.
Behavioral: Mindfulness and exercise
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.
Behavioral: Mindfulness
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.




Primary Outcome Measures :
  1. 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.

  2. Retention rate in study as feasibility [ Time Frame: 8 weeks ]
    Number and proportion of participants completing all assessments.

  3. 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.

  4. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants that describe themselves as female gender eligible to participate.
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05561413


Contacts
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Contact: Jackie Gracey, PhD +442890368284 jh.gracey@ulster.ac.uk
Contact: Ciara Hughes, PhD +442871675916 cm.hughes@ulster.ac.uk

Locations
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United Kingdom
Ulster University Recruiting
Belfast, Antrim, United Kingdom, BT1 6DN
Contact: Jackie Gracey    +442890368284    jh.gracey@ulster.ac.uk   
Contact: Ciara Hughes    +442871675916    cm.hughes@ulster.ac.uk   
Sponsors and Collaborators
University of Ulster
Investigators
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Principal Investigator: Jackie Gracey Ulster University
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Responsible Party: University of Ulster
ClinicalTrials.gov Identifier: NCT05561413    
Other Study ID Numbers: REC/21/00 76
First Posted: September 30, 2022    Key Record Dates
Last Update Posted: October 3, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Ulster:
Neoplasms
Mindfulness
Online
Additional relevant MeSH terms:
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Vulvar Neoplasms
Vaginal Neoplasms
Ovarian Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Vulvar Diseases
Vaginal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders