Condition category
Cancer
Date applied
23/10/2012
Date assigned
31/10/2012
Last edited
17/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Miss Kajal Gokal

ORCID ID

Contact details

School of Sport
Exercise and Health Sciences
Loughbrough University
L1.16 Wavy Top Building
Loughborough
LE11 3TU
United Kingdom
+44 (0)1509 228 152
k.gokal@lboro.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11/EM/0437

Study information

Scientific title

Physical activity intervention for emotional & cognitive functioning in breast cancer patients receiving chemotherapy

Acronym

Study hypothesis

1. Women who complete the physical activity intervention will report higher emotional well-being and show less impairment on memory, attention and concentration tasks in comparison to women in the non-intervention group.
2. Within the intervention group, emotional well-being will mediate between physical activity level and level of impairment in memory, attention and concentration.

Ethics approval

NRES committee East Midlands - Northampton, 02/02/2012, ref: 11/EM/0437

Study design

Interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

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

Breast cancer patients

Intervention

The study will involve 26 breast cancer patients committing to a 12-week home-based, moderate intensity walking intervention. Patients in this group will be provided with guidance, encouragement and motivation to incorporate 30 mins of moderate intensity walking five times a week around their treatment schedules. The control comparison will receive usual care only.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Measures of emotional distress and cognitive functioning.

Secondary outcome measures

Self-esteem, fatigue, intention to exercise, executive function, memory, attention, visual-spatial skills and motor function.

Overall trial start date

01/06/2012

Overall trial end date

01/10/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18-75 female breast cancer patients
2. Those who do not exceed recommended guidelines of 30 mins of moderate intensity exercise five times a week.
3. Those whose breast cancer is a primary diagnosis
4. Those who have no previous history of cancer
5. Those who are able to speak and read standard English

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

52

Participant exclusion criteria

1. Males
2. Those who exceed the recommended guidelines of 30 minutes exercise five times a week
3. Those whose breast cancer is a secondary diagnosis
4. Those who have previous history of cancer
5. Those who cannot speak and read Standard English

Recruitment start date

01/06/2012

Recruitment end date

01/10/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Loughbrough University
Loughborough
LE11 3TU
United Kingdom

Sponsor information

Organisation

Loughborough University (UK)

Sponsor details

c/o Peter Townsend
Research Office
Room 2.01
Rutland Building
Loughborough
LE11 3TU
United Kingdom

Sponsor type

University/education

Website

http://www.lboro.ac.uk/

Funders

Funder type

University/education

Funder name

School of Sport, Exercise and Health Science at Loughborough University (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 results in: http://www.ncbi.nlm.nih.gov/pubmed/26275768

Publication citations

Additional files

Editorial Notes