Gynaecology Exercise and Mindfulness Study

NCT05561413 | Unknown

• 1 other identifier: REC/21/00 76
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer; Uterus Cancer; Ovary Cancer; Cervical Cancer; Vaginal Cancer; Vulvar Cancer

Keywords

Neoplasms; Mindfulness; Online

Outcome Measures

Primary Outcomes (4)

• 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.

  12 months

• Retention rate in study as feasibility

  Number and proportion of participants completing all assessments.

  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.

  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).

  8 weeks

Secondary Outcomes (6)

• Fatigue

  Week 0 and 8

• Evaluate the Quality of Life

  Week 0 and 8

• Psychological outcomes

  Week 0 and 8

• Sleep

  Week 0 and 8

• Mindfulness

  Week 0 and 8

Study Arms (2)

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.

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.

Behavioral: Mindfulness

Interventions

Mindfulness and exercise BEHAVIORAL

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.

Mindfulness and exercise

Mindfulness BEHAVIORAL

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.

Mindfulness

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants that describe themselves as female gender eligible to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Ulster: lead

Study Sites (1)

Ulster University

Belfast, Antrim, BT1 6DN, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 37883461 DERIVED

MeSH Terms

Conditions

Uterine Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Vaginal Neoplasms; Vulvar Neoplasms; Neoplasms

Interventions

Mindfulness; Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Cervical Diseases; Vaginal Diseases; Vulvar Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jackie Gracey

  Ulster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jackie Gracey, PhD

CONTACT

+442890368284; jh.gracey@ulster.ac.uk

Ciara Hughes, PhD

CONTACT

+442871675916; cm.hughes@ulster.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 30, 2022
• Study Start: June 14, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

GB (1)