Can physical activity enhance emotion, memory, attention and concentration in breast cancer patients receiving chemotherapy?

ISRCTN	ISRCTN50709297
DOI	https://doi.org/10.1186/ISRCTN50709297
Secondary identifying numbers	11/EM/0437

Submission date: 23/10/2012
Registration date: 31/10/2012
Last edited: 23/04/2019

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

http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-at-physical-activity-during-chemotherapy-for-breast-cancer

Contact information

Miss Kajal Gokal
Scientific

School of Sport, Exercise and Health Sciences
Loughbrough University
L1.16 Wavy Top Building
Loughborough
LE11 3TU
United Kingdom

Phone	+44 (0)1509 228 152
Email	k.gokal@lboro.ac.uk

Study information

Study design	Interventional study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Home
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Physical activity intervention for emotional & cognitive functioning in breast cancer patients receiving chemotherapy
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(s)	NRES committee East Midlands - Northampton, 02/02/2012, ref: 11/EM/0437
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
Primary outcome measure	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 study start date	01/06/2012
Overall study end date	01/10/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	Female
Target number of participants	52
Total final enrolment	50
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 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

England
United Kingdom

Study participating centre

Loughbrough University

Loughborough
LE11 3TU
United Kingdom

Sponsor information

Loughborough University (UK)
University/education

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

Website	http://www.lboro.ac.uk/
"ROR"	https://ror.org/04vg4w365

Funders

Funder type

University/education

School of Sport, Exercise and Health Science at Loughborough University (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?
Results article	psychosocial wellbeing and physical activity results	01/03/2016		Yes	No
Results article	cognitive decline results	28/11/2018	23/04/2019	Yes	No

Editorial Notes

23/04/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment has been added from the results publication.