Condition category
Cancer
Date applied
25/07/2017
Date assigned
26/07/2017
Last edited
11/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Public

Primary contact

Mr Justin Webb

ORCID ID

Contact details

University of Surrey
Guildford
GU2 7XH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MoveMoreRCT

Study information

Scientific title

A randomised waiting list control trial, with embedded process evaluation, to investigate the impact of a physical activity health promotion pack on the wellbeing of people living with cancer

Acronym

Study hypothesis

Hypothesis:
A physical activity health promotion pack will improve physical activity levels in people living with cancer over provision of the physical activity guidelines.

Primary study aim:
The primary aim of this study is to test the effectiveness of a physical activity health promotion pack in moving people living with cancer categorised as ‘inactive’ or ‘moderately active’, to ‘active’.

Secondary study aims:
1. Testing the impact of the physical activity health promotion pack on the quality of life of people living with and beyond cancer
2. Sub group analysis to understand for whom the physical activity health promotion pack positively impacts upon physical activity and quality of life, in the context of pre-diagnosis levels of physical activity, and self-efficacy
3. A process evaluation to further understand the mechanisms for change

Ethics approval

University of Surrey Ethics Committee, 15/03/2017, ref: UEC/2017/023/FHMS

Study design

This is a two arm, waiting list control study with embedded process evaluation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

People living with cancer

Intervention

Participants are randomised using simple randomisation (toss of a coin) to either the intervention or the control group.

Intervention arm: A printed physical activity health promotion pack sent in the mail, supported by an online forum with patients and cancer specialist physiotherapist, online video case studies, and four e-newsletters sent to participants email accounts over 12 weeks.

Control: The guidelines for physical activity, sent in the mail.

This is a two arm, waiting list control study with embedded process evaluation. Participants in the control arm are sent, in the mail, the physical activity guidelines for people living with cancer. Participants in the intervention arm are sent, in the mail, a printed physical activity health promotion pack, and directed to online tools, as well as receiving four e-newsletters over 12 weeks. Data is collected via online survey on physical activity, self efficacy and quality of life at baseline, and at 12 weeks follow up. The intervention group will be followed up again at 24 weeks with the same measures collected. The control arm will receive the intervention at 12 weeks and will be followed up again at 24 weeks.

Use of the physical activity health promotion pack will be assessed as part of the online survey administered to the intervention group at 12 weeks. Participants from the intervention arm will be split into two groups, those inactive before their cancer diagnosis, and those active before their cancer diagnosis. Initially five participants from each of these group will be randomly selected to take part in a phone interview to gain a deeper understanding of their interaction with, and views of, the physical activity health promotion pack. Additional interviews will be conducted if new themes are still emerging following these initial phone interviews.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Physical activity levels are measured using the Godin Leisure-Time Exercise Questionnaire at baseline, 12weeks, and 24 weeks.

Secondary outcome measures

1. Quality of life is measured using the FACT-G7 questionnaire at baseline, 12weeks, and 24 weeks
2. Self-efficacy is measured using a single-item measure based on a previous study (Kampshoff, van Mechelen, Schep, Nijziel and Witlox et al. (2016)) at baseline, 12weeks, and 24 weeks

Overall trial start date

01/10/2016

Overall trial end date

31/10/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. People living with cancer
2. Aged 18 or over
3. Who can read English
4. Able to provide consent
5. Have an active e-mail account

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

164

Participant exclusion criteria

1. Those less than eight weeks post-surgery
2. Those experiencing extreme fatigue, anaemia or severe balance and coordination problems
3. Those with cancer in your bones, or bone thinning
4. Those with a heart or lung condition
5. Those experiencing pain in their chest at rest, during daily activities or when becoming active
6. Those experiencing persistent pain in their muscles, bones or joints
7. Those with swelling or inflammation in the abdomen, groin, or lower extremity
8. Those who have been informed by a doctor to only do medically supervised physical activity

Recruitment start date

20/03/2017

Recruitment end date

01/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Surrey
388 Stag Hill
Guildford
GU2 7XH
United Kingdom

Sponsor information

Organisation

University of Surrey

Sponsor details

388 Stag Hill
Guildford
GU2 7XH
United Kingdom

Sponsor type

University/education

Website

www.surrey.ac.uk

Funders

Funder type

Not defined

Funder name

University of Surrey

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Macmillan Cancer Support

Alternative name(s)

Macmillan

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of the protocol in the Journal of Medical Internet Research (JMIR). It is planned to publish the study results in a high-impact peer reviewed journal, with further dissemination at relevant conferences, such as the National Cancer Research Institute conference.

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

Intention to publish date

01/01/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/08/2017: Internal review.