CanWalk: a walking intervention for people with recurrent or metastatic cancer

ISRCTN	ISRCTN42072606
DOI	https://doi.org/10.1186/ISRCTN42072606
Secondary identifying numbers	N/A

Submission date: 24/03/2014
Registration date: 16/04/2014
Last edited: 20/06/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-walking-programme-for-people-who-have-cancer-that-has-come-back-or-spread-canwalk

Contact information

Dr Jo Armes
Scientific

Florence Nightingale School of Nursing and Midwifery
3.21 James Clerk Maxwell Building
57 Waterloo Road
London
SE1 1UL
United Kingdom

Study information

Study design	Feasibility study with exploratory multicentre randomised trial and qualitative interviewing
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Community
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A study to assess the acceptability and feasibility of a walking intervention for people with recurrent or metastatic cancer
Study acronym	CanWalk
Study objectives	Research question: are community-based walking programmes feasible and effective in enhancing physical and psychological outcomes in people with recurrent or metastatic cancer? Secondary research questions: the study will refine the walking intervention and ensure a full randomised controlled trial is appropriate and feasible. Objectives: 1. Refine a brief intervention to encourage the uptake of the walking intervention 2. Investigate the acceptability to participants of: 2.1. The walking intervention 2.2. The study materials 2.3. Being randomised to intervention or control 2.4. The selected outcome measures 2.5. Using pedometers to assess adherence 3. Estimate the following factors needed to design the main study: 3.1. Number of eligible participants 3.2. Recruitment rate 3.4. Retention rate 3.5. Response rates to initial and follow-up questionnaires 3.6. Utility of objective and subjective methods to assess adherence to the walking intervention 4. Generate evidence to be used to estimate sample size for a future randomised controlled trial
Ethics approval(s)	NRES Committee North West - Lancaster, HRA NRES Centre - Manchester, 06/12/2013, ref: 13/NW/0860
Health condition(s) or problem(s) studied	Recurrent or metastatic cancer
Intervention	The intervention comprises a brief (10-minute) telephone or face-to-face session, based on NICE public health guidance on physical activity (NICE, 2013). It will discuss the importance and benefits of physical activity, and promote goal setting, action planning and self-monitoring as a means to increase physical activity. Study materials will also be provided in print and online formats to reinforce the intervention. Information on local Walking For Health (WfH) groups will be provided, including details of the WfH co-ordinator in the participant's local area. The intervention will be delivered by the researcher trained in motivational interviewing, which is a patient-centred, counselling-style approach that builds on an individual's motivation to change behaviour. The intervention sessions will, with consent, be audio-recorded and a random selection rated to ensure fidelity to the intervention manual. Participants will be randomised 1:1 between the intervention (n=30) and standard care (n=30) using minimisation. Participants in the intervention group will be asked to participate in at least one WfH group activity per week and undertake walking on alternate days over 3 months, either independently or with WfH groups. The control group will be asked to continue their activities as usual during the study. Participants will complete questionnaires at baseline (T0), 6 (T1), 12 (T2) and 24 (T3) weeks. Before posting out the follow-up questionnaires, the research team will contact the clinician responsible for the participant's care to check their current health status. To collect data on physical activity levels, half of the participants in the intervention and control groups will be randomly allocated pedometers and will wear them for 7 days at the time of each assessment. Those patients randomly selected will be asked to collect baseline pedometer data once the research team has received a signed consent form. Patients will be asked to fill in a simple sheet recording how many steps they took each day over the 7-day period. Semi-structured telephone interviews will be conducted with 10 participants (five per study group) to assess the acceptability of the intervention and evaluation methods. At the end of the intervention a maximum of 10 stakeholders (WfH Co-ordinators/walk leaders, Clinical Nurse Specialists, Oncologists, etc.) will be interviewed to determine the acceptability and feasibility of the walking intervention from a professional perspective.
Intervention type	Other
Primary outcome measure	The feasibility and acceptability of a walking intervention that combines a motivational element with a pre-existing and nationally available walking programme
Secondary outcome measures	Participants will complete the following questionnaires at baseline (T0), 6 (T1), 12 (T2) and 24 (T3) weeks: 1. Quality of Life (Functional Assessment of Cancer Therapy scale- General; EuroQol) 2. Physical activity level (Scottish Physical Activity Questionnaire; General Practice Physical Activity Questionnaire) 3. Fatigue (Brief Fatigue Inventory) 4. Distress (depression anxiety stress scales) 5. Exercise self-efficacy (Spinal Cord Injury, to measure exercise self-efficacy) At baseline and 24 weeks participants performance status will also be assessed (Eastern Cooperative Oncology Group) and the strength of their motivation to change behaviour using a brief ruler (100 mm visual analogue scale)
Overall study start date	01/02/2014
Completion date	01/02/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60
Key inclusion criteria	1. 16 years of age or older 2. Diagnosed with metastatic or recurrent cancer in the previous 6 months 3. Able to walk for a minimum of 30 minutes unaided
Key exclusion criteria	1. Bone metastases that the clinician in charge of the patient's care considers a contra-indication to participating in the walking intervention 2. Unable to speak and understand English
Date of first enrolment	01/04/2014
Date of final enrolment	30/11/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Florence Nightingale School of Nursing and Midwifery

London
SE1 1UL
United Kingdom

Sponsor information

King's College London (UK)
University/education

c/o Keith Brennan
Room 1.8 Hodgkin Building
Guy's Campus
London
SE1 1UL
England
United Kingdom

Website	http://www.kcl.ac.uk
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Charity

Dimbleby Cancer Care (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Protocol article	protocol	01/12/2015		Yes	No
Results article	results	15/02/2017		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

20/06/2019: Cancer Research UK lay results summary link added to Results (plain English).
17/02/2017: Publication reference added.
10/11/2014: The following changes were made to the trial record:
1. The overall trial start date was changed from 01/04/2014 to 01/02/2014.
2. The overall trial end date was changed from 01/07/2014 to 01/02/2015.