Condition category
Cancer
Date applied
11/02/2019
Date assigned
13/02/2019
Last edited
25/07/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
People with the blood cancer myeloma who undergo chemotherapy are not routinely prescribed exercise or physical activity advice as part of their treatment and many are even told to rest or not to exercise because of pain and bone disease related to their cancer. Yet research studies tell us that exercising before, during and after cancer treatment can be beneficial and that excessive rest or being inactive can have detrimental effects on wellbeing. As the medical treatment for cancer gets better and more people are surviving, it is important that people have other ‘therapies’ to help them prepare for and potentially combat the side effects of their cancer treatment. This maybe especially important for myeloma patients who are receiving an intensive treatment called stem cell transplant. The primary aim of this study is to evaluate the feasibility of delivering a physiotherapist-led exercise and behaviour change intervention before and during stem cell transplant treatment in people with myeloma. Secondary objectives are to investigate the possible effect of the intervention on a range of measures including fatigue, quality of life, physical activity and functional capacity.

Who can participate?
Patients with myeloma who are having stem cell transplant treatment at University College Hospital

What does the study involve?
Participants are randomly allocated one of two groups: an exercise intervention group and a usual care control group. The exercise group undertake individually tailored aerobic and resistance exercise with behaviour change support during three phases of their treatment. In phase 1, for 6-8 weeks before they come into hospital for their stem cell transplant they are asked to exercise three times per week. They are asked to take part in one session a week with a physiotherapist in a gym and complete two other sessions at home. In phase 2, during their hospital stay, immediately after their stem cell transplant, the exercise participants are offered supervised exercise sessions with a physiotherapist three times per week. In phase 3, for 3 months after they leave hospital the participants are asked to continue exercising at home three times per week. They receive weekly phone or Skype support from a physiotherapist to promote and support continuation or return to independent exercise in the post-transplant period.

What are the possible benefits and risks of participating?
The results of this study may help improve the experience of people with myeloma undergoing stem cell transplant and lead to further large-scale research into the role of exercise as part of the transplant treatment pathway.

Where is the study run from?
University College London Hospitals NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
September 2018 to November 2020

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Orla McCourt
o.mccourt@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Ms Orla McCourt

ORCID ID

http://orcid.org/0000-0001-7572-2540

Contact details

University College London Hospitals NHS Foundation Trust
London
NW1 2BU
United Kingdom
+44 (0)20 7679 1736
o.mccourt@nhs.net

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

40801

Study information

Scientific title

Pilot randomised controlled trial of a physiotherapist-led exercise intervention delivered prior to and during stem cell transplant in patients with myeloma

Acronym

PERCEPT

Study hypothesis

The primary objective of this study is to evaluate the feasibility of delivering an exercise and behaviour change intervention prior to and during the usual autologous stem cell transplant treatment pathway in people with myeloma. Secondary objectives are to investigation of the possible effect of the intervention on a range of measures including fatigue, quality of life, physical activity and functional capacity.

Ethics approval

Approved 26/03/2019, NHS Health Authority Research Ethics Committee - Camden and Kings Cross (Tel: +44 (0)207 972 2561; Email: nrescommittee.london-camdenandkingscross@nhs.net), ref: 19/LO/0204

Study design

Randomised; Interventional; Design type: Treatment, Education or Self-Management, Psychological & Behavioural, Complex Intervention, Physical, Rehabilitation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Myeloma

Intervention

This pilot randomised, single site trial will involve participants with myeloma undergoing autologous stem cell transplantation (ASCT). This trial has two arms; an exercise intervention arm and a usual care control arm. Eligible participants will be randomised to an exercise intervention group or usual care control group.

Participants randomised to the exercise intervention arm will be asked to undertake a partly supervised, physiotherapist led, individually tailored exercise programme for up to 8 weeks prior to their transplant as an outpatient, which will be continued during hospitalisation for transplant treatment. The exercise programme will be carried out three time per week. Following discharge from hospital, the participants in the exercise intervention arm will be offered weekly telephone support from a physiotherapist to promote and support continuation or return to independent exercise in the post transplant period (for up to 3 months).

Assessments will be conducted at four timepoints: baseline assessment 4-6 weeks prior to ASCT, and follow up assessments on day before or day of transplantation, on discharge from hospital and three months’ post ASCT. Assessments will involve questionnaires regarding fatigue, quality of life (QOL), exercise self-efficacy, physical activity, accelerometery and physical assessments including a walk test, sit to stand test and handheld dynamometry. In the final follow up participants will also complete a questionnaire on health and social care usage and approximately 20 participants will participant in qualitative interviews.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The feasibility of the intervention including:
1. Percentage uptake (recruitment rate)
2. Adherence to the intervention and acceptability of receiving the intervention (including any deviation from exercise protocol)
3. Attrition due to the intervention, loss to follow-up and adverse event rate
These will be assessed by extracting data from screening and recruitment logs, attendance at supervised exercise training sessions and review of independent exercise log book records and review of adverse events;

Secondary outcome measures

The following measures will be taken at four timepoints (at baseline 6-8 weeks before transplant, around day of their transplant, on discharge from transplant hospital admission and 3 months following date of transplant):
1. Fatigue, measured using the Functional Assessment of Chronic Illness Therapy (FACIT-F)
2. Quality of life, measured using the European Organisation for Research and Treatment of Cancer QOL Questionnaire (EORTC QLQ-C30 and myeloma specific module QLQ- MY20), Functional Assessment of Cancer Therapy Bone Marrow Transplantation scale (FACT- BMT) and EuroQol-5D
3. Frailty, measured using the International Myeloma Working Group Frailty Assessment outcome measure
4. Physical activity and sedentary time, measured using ActivPAL accelerometers
5. Functional capacity, measured using the six minute walk test, hand held dynamometry and a timed 30 second sit to stand test
6. Self-reported physical activity behaviour and self-efficacy, measured using the short form International Physical Activity Questionnaire (IPAQ-SF) and Exercise Self-Efficacy Scale (ESES)
7. Resting blood pressure and heart rate
8. Height and weight
9. Blood count and markers of immune system function, measured using blood samples

The following measures will be taken at the final timepoint only (3 months following date of transplant):
1. Health and social care service use in the acute post-transplant period, including transplant hospital admission, using a questionnaire and medical record review
2. Qualitative interviews with a purposeful sample of up to 20 study participants

Overall trial start date

01/09/2018

Overall trial end date

30/11/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adult patients referred to the UCLH transplant multidisciplinary team (MDT) and awaiting autologous stem cell transplant as treatment for myeloma
2. Clinically able to carry out an exercise training programme on a regular basis
3. Patients must have a good command of written and spoken English
4. Willing and able to provide written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 75; UK Sample Size: 75

Participant exclusion criteria

1. Patients with known spinal instability, spinal cord compression or neurological deficits
2. Those who have had recent (within six weeks) spinal surgery or other surgery for pathological fractures
3. Abnormal resting ECG and/or unstable angina
4. Those deemed unsuitable to partake by the MDT
5. Unable or unwilling to undertake an exercise programme on a regular basis

Recruitment start date

26/05/2019

Recruitment end date

30/07/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London Hospitals NHS Foundation Trust
London
NW1 2BU
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Joint Research Office
1st Floor
Maple House – Suite B
149 Tottenham Court Road
London
W1T 7DN
United Kingdom
+44 (0)2034475696
uclh.randd@nhs.net

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Academy; Grant Codes: ICA-CDRF-2017-03-067

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A protocol paper for this study is in draft and will be published in an open-access journal once ethical approval has been granted. Results from this research will be published in open access peer reviewed journals that target audiences in the fields of haematology, physiotherapy and physical activity research, within one year from completion of the study.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/11/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/07/2019: The following changes were made to the trial record: 1. The recruitment start date was changed from 01/03/2019 to 26/05/2019. 2. The ethics approval details were added.