Condition category
Cancer
Date applied
28/09/2010
Date assigned
29/10/2010
Last edited
26/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Deborah Fenlon

ORCID ID

Contact details

University Road
Southampton
SO17 1BJ
United Kingdom
-
dfenlon@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7170

Study information

Scientific title

A longitudinal cohort study of joint and muscle aches, pains and stiffness in women with primary breast cancer

Acronym

JACS

Study hypothesis

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

MREC approved on 04/08/2009, ref: 09/H0501/44

Study design

Observational multicentre non-randomised longitudinal cohort study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast

Intervention

Interventions will be determined by findings.

Follow up length: 3 months
Study entry: other

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Descriptive statistics will be used to describe the prevalence at Times 1 - 5 of joint stiffness

Secondary outcome measures

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

Overall trial start date

04/01/2010

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned sample size: 500; UK sample size: 500

Participant 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.

Recruitment start date

27/01/2010

Recruitment end date

31/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Road
Southampton
SO17 1BJ
United Kingdom

Sponsor information

Organisation

Southampton University Hospitals NHS Trust (UK)

Sponsor details

Cancer Care Directorate
B Level
Mailpoint WRE
Royal South Hants Hospital
Graham Road
Southampton
SO14 0YG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.suht.nhs.uk/home.aspx

Funders

Funder type

Charity

Funder name

Breast Cancer Campaign (UK) (ref: 2008MayPR49)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24964929

Publication citations

Additional files

Editorial Notes