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Gynaecology Exercise and Mindfulness Study (GEMS)

Primary Purpose

Gynecologic Cancer, Uterus Cancer, Ovary Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Mindfulness and exercise
Mindfulness
Sponsored by
University of Ulster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gynecologic Cancer focused on measuring Neoplasms, Mindfulness, Online

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Ulster UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness and exercise

Mindfulness

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Retention rate in study as feasibility
Number and proportion of participants completing all assessments.
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.
Feasibility as assessed by adherence
Will be assessed by frequency and duration of practicing of exercise and mindfulness (recorded in a log via app).

Secondary Outcome Measures

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.
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.
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.
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.
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.
Physical activity
International physical activity questionnaire (IPAQ) short form will be used to evaluate the effects on levels of activity

Full Information

First Posted
September 20, 2022
Last Updated
September 29, 2022
Sponsor
University of Ulster
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1. Study Identification

Unique Protocol Identification Number
NCT05561413
Brief Title
Gynaecology Exercise and Mindfulness Study
Acronym
GEMS
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ulster

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer, Uterus Cancer, Ovary Cancer, Cervical Cancer, Vaginal Cancer, Vulvar Cancer
Keywords
Neoplasms, Mindfulness, Online

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness and exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Mindfulness
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness and exercise
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention 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.
Primary Outcome Measure Information:
Title
Feasibility of eligibility and enrollment
Description
Number of eligible participants, and the proportion of those eligible that enrolled will be assessed to evaluate the feasibility of eligibility and enrollment.
Time Frame
12 months
Title
Retention rate in study as feasibility
Description
Number and proportion of participants completing all assessments.
Time Frame
8 weeks
Title
Feasibility as assessed by rate of attrition
Description
The number of participants dropping out after start of intervention for any reason will be assessed to evaluate attrition rate.
Time Frame
8 weeks
Title
Feasibility as assessed by adherence
Description
Will be assessed by frequency and duration of practicing of exercise and mindfulness (recorded in a log via app).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Fatigue
Description
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.
Time Frame
Week 0 and 8
Title
Evaluate the Quality of Life
Description
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.
Time Frame
Week 0 and 8
Title
Psychological outcomes
Description
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.
Time Frame
Week 0 and 8
Title
Sleep
Description
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.
Time Frame
Week 0 and 8
Title
Mindfulness
Description
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.
Time Frame
Week 0 and 8
Title
Physical activity
Description
International physical activity questionnaire (IPAQ) short form will be used to evaluate the effects on levels of activity
Time Frame
Week 0 and 8

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants that describe themselves as female gender eligible to participate.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jackie Gracey, PhD
Phone
+442890368284
Email
jh.gracey@ulster.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Ciara Hughes, PhD
Phone
+442871675916
Email
cm.hughes@ulster.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jackie Gracey
Organizational Affiliation
Ulster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ulster University
City
Belfast
State/Province
Antrim
ZIP/Postal Code
BT1 6DN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackie Gracey
Phone
+442890368284
Email
jh.gracey@ulster.ac.uk
First Name & Middle Initial & Last Name & Degree
Ciara Hughes
Phone
+442871675916
Email
cm.hughes@ulster.ac.uk

12. IPD Sharing Statement

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Gynaecology Exercise and Mindfulness Study

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