Joint and muscle aches, pains and stiffness in women with primary breast cancer

ISRCTN	ISRCTN55839425
DOI	https://doi.org/10.1186/ISRCTN55839425
Protocol serial number	7170
Sponsor	Southampton University Hospitals NHS Trust (UK)
Funder	Breast Cancer Campaign (UK) (ref: 2008MayPR49)

Submission date: 28/09/2010
Registration date: 29/10/2010
Last edited: 25/10/2022

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-joint-muscle-aches-pain-stiffness-women-breast-cancer-jacs

Contact information

Dr Deborah Fenlon
Scientific

University Road
Southampton
SO17 1BJ
United Kingdom

Email	dfenlon@soton.ac.uk

Study information

Primary study design	Observational
Study design	Observational multicentre non-randomised longitudinal cohort study
Secondary study design	Longitudinal study
Study type	Participant information sheet
Scientific title	A longitudinal cohort study of joint and muscle aches, pains and stiffness in women with primary breast cancer
Study acronym	JACS
Study objectives	1. To establish the natural history of joint and muscle aches, pains and stiffness (JaMAPS) over time in women being treated for early breast cancer (BC) 2. To investigate whether and how the prevalence and natural history of JaMAPS differs in women receiving adjuvant therapy for invasive early BC from that in women following treatment for ductal carcinoma in situ (DCIS) 3. To explore the impact of JaMAPS on quality of life (QoL) in women with invasive early BC 4. To explore their impact on functional ability 5. To undertake an exploratory analysis of how the natural history of JaMAPS differs between adjuvant treatment groups Study findings will be used to educate health professionals about the natural history and impact of these under-researched and under-treated symptoms, better equipping them to support patients and enabling them to provide more accurate information to patients to inform treatment decisions. Findings will inform future research into both the causes of JaMAPS in BC and into effective interventions.
Ethics approval(s)	MREC approved on 04/08/2009, ref: 09/H0501/44
Health condition(s) or problem(s) studied	Breast cancer
Intervention	Interventions will be determined by findings. Follow up length: 3 months Study entry: other
Intervention type	Other
Primary outcome measure(s)	Descriptive statistics will be used to describe the prevalence at Times 1 - 5 of joint stiffness
Key secondary outcome measure(s)	1. The statistical significance (if any) of differences in pain prevalence, severity and interference 2. Descriptive statistics will be used to describe the QoL and functional status of women at each time 3. Descriptive statistics will be used to compare joint pain, pain severity and interference 4. Exploratory analysis, again using descriptive statistics and the mixed method approach to modelling
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	500
Total final enrolment	543
Key inclusion criteria	1. Diagnosis of BC (invasive or DCIS) 2. Aged at least 18 years old 3. No evidence of metastatic disease 4. Able to complete written records in English 5. Female
Key exclusion criteria	Men will be excluded from this study because their numbers are likely to be extremely low: effects of gender on joint pain can explored in a future multi-centred study.
Date of first enrolment	27/01/2010
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University Road

Southampton
SO17 1BJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	25/06/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			25/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
17/03/2020: Internal review.