Condition category
Cancer
Date applied
24/03/2014
Date assigned
16/04/2014
Last edited
13/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Jo Armes

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A study to assess the acceptability and feasibility of a walking intervention for people with recurrent or metastatic cancer

Acronym

CanWalk

Study hypothesis

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

On 10/11/2014 the following changes were made to the trial record:
1. The anticipated start date was changed from 01/04/2014 to 01/02/2014.
2. The anticipated end date was changed from 01/07/2014 to 01/02/2015.

Ethics approval

NRES Committee North West - Lancaster, HRA NRES Centre - Manchester, 06/12/2013, REC ref: 13/NW/0860

Study design

Feasibility study with exploratory multicentre randomised trial and qualitative interviewing

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/02/2014

Overall trial end date

01/02/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

01/04/2014

Recruitment end date

30/11/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Florence Nightingale School of Nursing and Midwifery
London
SE1 1UL
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.kcl.ac.uk

Funders

Funder type

Charity

Funder name

Dimbleby Cancer Care (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.pilotfeasibilitystudies.com/content/1/1/7/abstract

Publication citations

Additional files

Editorial Notes