Exercise as an Intervention in Endometrial Cancer Survivors

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Brief Title

Exercise as an Intervention in Endometrial Cancer Survivors

Official Title

Feasibility and Acceptability of Exercise as a Lifestyle Intervention in Endometrial Cancer Survivors.

Brief Summary

      The purpose of the study is to evaluate the feasibility of introducing an exercise programme
      for endometrial cancer survivors.
    

Detailed Description

      Objectives

        -  To evaluate the feasibility of an exercise intervention for endometrial cancer survivors
           in terms of recruitment, adherence, response rates, and follow-up rate.

        -  To evaluate the feasibility of the individual components of the exercise programme
           itself within the study population.

        -  To evaluate if the outcomes measure used to evaluate quality of life outcomes such as
           psychological distress, fatigue and pain in endometrial cancer survivors are
           appropriate.

        -  To evaluate if the outcome measures used to evaluate physical fitness are appropriate.

        -  To evaluate the acceptability of an exercise intervention for endometrial cancer
           survivors to improve quality of life outcomes.

      General research design Single-arm prospective feasibility study In addition we will conduct
      a qualitative evaluation with a purposively selected subgroup with maximum variation of our
      population.

      Study population All women diagnosed at the Royal Cornwall Hospital with endometrial cancer
      who have completed surgical treatment.

      Number of participants Every year approximately 90 women are diagnosed with endometrial
      cancer at the Royal Cornwall Hospital in Truro, of which approximately 80 women receive
      primary surgical treatment. We estimate that 50% to 60% will consent to participation in this
      study; we therefore anticipate that the sample size for a study duration of 12 months will be
      approximately 40 to 48 women.

      As this is a feasibility study, we have not performed a power analysis.

      Setting Single centre study at the Royal Cornwall Hospital, Truro.

      Selection and identification Women with a confirmed diagnosis of endometrial cancer will be
      introduced to the study by a member of the clinical team post-operatively during admission
      for surgery.

      Identification of potential participants will be performed by a member of the clinical care
      team (consisting of three gynaecological oncologists, a Clinical Nurse Specialist (CNS) and a
      clinical research fellow). This will be performed through the review of medical records using
      case notes and an electronic clinical database system (MAXIMS), before the start of the
      gynaecological oncologist clinic and during multidisciplinary gynaecological oncology team
      meetings.

      Recruitment Potential participants will be introduced to the study by the clinical care team
      during their admission for surgical treatment and a study information sheet will be given.
      Potential participants will be asked if a member of the clinical team can contact them by
      telephone, one week after they are discharged home, to discuss the study in detail and their
      possible participation. Following this telephone call, only women who express an interest in
      participating in the study will be further approached at their next outpatient clinic
      appointment (6 weeks post-operative). Informed consent for the study will be sought during
      this patient's clinical visit, which occurs at approximately 6 weeks after the operation.
      During this process the gynaecological oncologist, the CNS or the clinical research fellow
      will explain the details of the study, the risks, burdens and possible benefits, and answer
      any additional questions the patient may have.

      Intervention In this study, the intervention itself will be delivered by a male Cancer
      Exercise Specialist, funded by a local charity 'Active Pants', who provide a post-treatment
      rehabilitation programme for cancer patients. The programme objectives are to improve health
      status and promote a healthy lifestyle, and are based on specific and national guidelines
      (27-29).

      Prior to starting the programme, participants receive a health and physical fitness
      assessment by the Cancer Exercise Specialist. The health assessment will include their
      current health and physical activity level according to the patient, any medical conditions
      and medical history, and other restrictions the patient may experience in terms of
      exercising. The physical fitness assessment will include measuring weight and height, waist
      circumference, body fat percentage, muscle percentage and resting metabolism and the 6-minute
      walk test. In addition, any personal goals of the patient will be identified. This will take
      approximately 30 minutes.

      The exercise programme consists of 60-min individualised (one-on-one) personal training
      sessions, once a week, for 10 weeks. Each session consists of a 10 min warm-up, a 40-min work
      out, consisting of cardiovascular exercise, pillar strength exercise (including hip and core
      stability), and resistance training (muscular strength and endurance training), and a 10-min
      cooling down including flexibility training (see Appendix 3). The programme will be tailored
      to the individual patient by the Cancer Exercise Specialist, taking into consideration their
      current health status, comorbidities and medical history. A personal Cancer Exercise
      Specialist with experience in various cancer areas will supervise the exercise programme one
      on one with the participant, giving them a specific set of exercised each session, tailored
      to the individual patient.

      After completion of the 10-week supervised exercise programme, participants are given the
      opportunity to continue their training in weekly group sessions for free, supervised by the
      same Exercise Specialist.

      The Exercise Specialist will document the attendance rates of participants and if
      participants completed their 10 exercise sessions. The 6-min walk test will be performed
      after completion of the 10th session of the programme to assess a possible change in physical
      fitness compared to baseline physical fitness. In addition the Exercise Specialist will
      document the individual response of participants to components of the exercise sessions and
      how they were tolerated.

      Follow-up Follow-up will take place after completion of the exercise sessions at the standard
      clinical visit with the gynaecological oncology team, which is 3 to 4 months after the
      post-operative (6 week) visit. Patients will then come back again after 3 months.

      Data management Data will be collected by the clinical care team (gynaecological oncologists,
      the CNS, and clinical research fellow) when the patients attend for their routine outpatient
      appointments. The data will be anonymised prior to being analysed by the clinical research
      fellow on a password secured NHS computer at the Royal Cornwall Hospital in Truro. Data will
      remain in a password secured file on this computer and will not be transferred onto another
      medium or outside the hospital Trust. The manual files including the questionnaires will be
      stored in a locked office within the Royal Cornwall Hospital.

      Project Management The day-to-day management of the study will be undertaken by the Chief
      Investigator with the support of the Clinical Research Fellow. The general conduct and
      progress of the study will be overseen by a Study Management Group (SMG). This group will
      comprise the chief investigator, the clinical research fellow and the study data analyst,
      with occasional attendance by a sponsor's representative and patient representative as
      required. The SMG will meet often during the study set-up and less frequently once the study
      is underway with minutes circulated to all SMG members.

      The sponsor, Royal Cornwall Hospital, has arrangements in place to monitor or audit the
      conduct of the study as part of the sponsor's obligations under the Department of Health's
      Research Governance Framework. The purpose of an audit or inspection is to systematically and
      independently examine all study related activities and documents to determine whether these
      activities were conducted, and data were recorded, analysed, and accurately reported
      according to the protocol, Good Clinical Practice (GCP), ICH guidelines, and any applicable
      regulatory requirements.
    


Study Type

Interventional


Primary Outcome

The number of invited participants that complete the tailored exercise programme (10 exercise sessions).

Secondary Outcome

 Change from baseline in the EORCT QLQ-C30 quality of life outcome measures at 18 months and change from baseline in the QLQ-EN24 quality of life outcome measures at 18 months.

Condition

Endometrial Cancer

Intervention

Exercise

Study Arms / Comparison Groups

 Single Arm Study
Description:  All participants receive active treatment (exercise) tailored to their level of health ad fitness

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

50

Start Date

January 2015

Completion Date

July 2016

Primary Completion Date

January 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Confirmed diagnosis of endometrial cancer

          -  Completion of surgical treatment for endometrial cancer

          -  Age; 18 years or older.

        Exclusion Criteria:

          -  Women receiving treatment in the palliative setting

          -  Women with recurrent diagnosis of endometrial cancer

          -  Women with concurrent cancer

          -  Women who are unable to give informed consent
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Chris Cannaby, BA, 0044 1872 252731, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT02367950

Organization ID

2014.RCHT.62


Responsible Party

Principal Investigator

Study Sponsor

Royal Cornwall Hospitals Trust


Study Sponsor

Chris Cannaby, BA, Study Director, United Kindom: Royal Cornwall Hospital


Verification Date

February 2015