Breast CancerNCT02754427
Pilot Study for a Prospective Surveillance Program for Rehabilitation Following Surgery for Breast Cancer
A study testing Prospective Surveillance Group and Education Group in people with Breast Cancer, run by University of British Columbia.
Trial summary
Breast cancer treatment often results in long-term arm morbidity. A prospective surveillance model with arm assessment pre-surgery followed by ongoing surveillance and targeted physiotherapy treatment after breast cancer surgery may improve early detection and management of arm morbidity. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Prospective Surveillance Group and Education Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 30-75 years; receiving surgery for breast cancer, including those who will have immediate breast reconstruction.
Who cannot join
- prior breast cancer surgery; a pre-existing shoulder pathology on the side of breast surgery that limits shoulder range of motion <75% of non-affected side; or a diagnosis of primary lymphedema
About this study
Breast cancer treatment often results in long-term arm morbidity. A prospective surveillance model with arm assessment pre-surgery followed by ongoing surveillance and targeted physiotherapy treatment after breast cancer surgery may improve early detection and management of arm morbidity. This study aims to determine the effect of prospective surveillance to target physiotherapy on the prevalence of arm morbidity in the surveillance group compared to control group at 12-months after breast cancer surgery.
- Conditions
- Breast Cancer
- Being tested
- Prospective Surveillance Group, Education Group
- Keywords
- Surveillance, Physiotherapy, Arm morbidity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective Surveillance GroupBehavioural
Also called Prospective surveillance for arm morbidity and physiotherapy treatment
Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the surveillance group underwent the same arm assessment at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any of those time points, then the participant was referred to individual physiotherapy treatment until the issue was resolved.
Education GroupBehavioural
Also called Attention Control Group
Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the education group were asked to attend three patient education sessions on nutrition, stress management, and fatigue management of approximately 1 hour, delivered at 3, 6, and 9 months by study staff.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Surveillance Group | Experimental | Women assigned to surveillance group were assessed for arm morbidity at pre-surgery and at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any time-point post-surgery, then a physiotherapy intervention was prescribed. Receives: Behavioral: Prospective Surveillance Group |
| Education Group | Active comparator | Participants in the education group received the usual post-operative follow-up. Receives: Behavioral: Education Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Shoulder Mobility
Arm morbidity due to decreased shoulder mobility was defined as ≥10% decrease in mobility from pre-surgery. This was measured using a goniometer and evaluated the degrees of shoulder mobility in flexion, abduction and external rotation.
Measured: 12 months
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Muscle Strength
Arm morbidity due to decreased upper body muscle strength was defined as ≥25% decrease in muscle strength from pre-surgery. This was measured using a hand-held dynamometer and evaluated in kilograms.
Measured: 12 months
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Function
Arm morbidity due to decreased upper body function was defined as ≥10 points decrease in function from pre-surgery. This was measured using the Upper Extremity Functional Index that scores 0 to 80, with higher scores indicating greater level of function.
Measured: 12 months
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Arm Volume
Arm morbidity due to increase in arm volume was defined as a ≥200 mL increase from pre-surgery. Arm volume was measured using a perometer.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startFeb 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Campbell, University of British Columbia
- Investigators
- Kristin Campbell, PhD, Principal investigator, kristin.campbell@ubc.ca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754427
- Sponsor's protocol ID
- H12-01773
- Status last verified
- Oct 2019
- First submitted
- 22 Apr 2016
- Last updated
- 25 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for a Prospective Surveillance Program for Rehabilitation Following Surgery for Breast Cancer
- ClinicalTrials.gov ID
- NCT02754427
- Acronym / sponsor ID
- H12-01773
- Conditions
- Breast Cancer
- Keywords
- Surveillance, Physiotherapy, Arm morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Posted 25 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer treatment often results in long-term arm morbidity. A prospective surveillance model with arm assessment pre-surgery followed by ongoing surveillance and targeted physiotherapy treatment after breast cancer surgery may improve early detection and management of arm morbidity. This study aims to determine the effect of prospective surveillance to target physiotherapy on the prevalence of arm morbidity in the surveillance group compared to control group at 12-months after breast cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Surveillance Group | Experimental | Behavioral: Prospective Surveillance GroupWomen assigned to surveillance group were assessed for arm morbidity at pre-surgery and at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any time-point post-surgery, then a physiotherapy intervention was prescribed. |
| Education Group | Active comparator | Behavioral: Education GroupParticipants in the education group received the usual post-operative follow-up. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 30-75 years; receiving surgery for breast cancer, including those who will have immediate breast reconstruction.
Key exclusion criteria (1 listed)
- prior breast cancer surgery; a pre-existing shoulder pathology on the side of breast surgery that limits shoulder range of motion <75% of non-affected side; or a diagnosis of primary lymphedema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective Surveillance GroupAlso: Prospective surveillance for arm morbidity and physiotherapy treatmentParticipants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the surveillance group underwent the same arm assessment at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any of those time points, then the participant was referred to individual physiotherapy treatment until the issue was resolved. | Behavioural | Prospective Surveillance Group |
| Education GroupAlso: Attention Control GroupParticipants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the education group were asked to attend three patient education sessions on nutrition, stress management, and fatigue management of approximately 1 hour, delivered at 3, 6, and 9 months by study staff. | Behavioural | Education Group |
Primary outcome
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Shoulder Mobility
Time frame: 12 months
Arm morbidity due to decreased shoulder mobility was defined as ≥10% decrease in mobility from pre-surgery. This was measured using a goniometer and evaluated the degrees of shoulder mobility in flexion, abduction and external rotation.
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Muscle Strength
Time frame: 12 months
Arm morbidity due to decreased upper body muscle strength was defined as ≥25% decrease in muscle strength from pre-surgery. This was measured using a hand-held dynamometer and evaluated in kilograms.
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Function
Time frame: 12 months
Arm morbidity due to decreased upper body function was defined as ≥10 points decrease in function from pre-surgery. This was measured using the Upper Extremity Functional Index that scores 0 to 80, with higher scores indicating greater level of function.
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Arm Volume
Time frame: 12 months
Arm morbidity due to increase in arm volume was defined as a ≥200 mL increase from pre-surgery. Arm volume was measured using a perometer.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Campbell, PhD principal investigator
kristin.campbell@ubc.ca
Questions about this trial
What is this clinical trial studying?
A study testing Prospective Surveillance Group and Education Group in people with Breast Cancer, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Shoulder Mobility (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019.