Trial Outcomes & Findings for The Breast Cancer Online Rehabilitation Program (NCT NCT02673918)
NCT ID: NCT02673918
Last Updated: 2019-12-13
Results Overview
This outcome represent the number and proportion (%) of eligible patients who consented to participate in the study. Recruitment was open for 10 weeks for participants in Part 1 and for 20 weeks for participants in Part 2.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
10 weeks for part 1 and 20 weeks for part 2
Results posted on
2019-12-13
Participant Flow
We had pre-defined recruitment period and not a sample size goal. The recruitment period was 10 weeks for part 1 of the study (recruiting women within 8 weeks of surgery for breast cancer) and 20 weeks for part 2 (recruiting women within 6 weeks of completing radiation therapy for breast cancer).
Participant milestones
| Measure |
Part 1: Home-based Rehabilitation
Home-based upper-body rehabilitation with online support
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
Part 2: Home-based Rehabilitation
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
24
|
|
Overall Study
COMPLETED
|
29
|
20
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Breast Cancer Online Rehabilitation Program
Baseline characteristics by cohort
| Measure |
Part 1: Home-based Rehabilitation
n=35 Participants
Home-based upper-body rehabilitation with online support
Home-based upper-body rehabilitation with online support: Participants will be given written educational material, in which the physiotherapist marks the exercises specifically recommended for the individual patient. In addition, participants will get a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants will complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
Part 2: Home-based Rehabilitation
n=24 Participants
Home-based upper-body rehabilitation with online support
Home-based upper-body rehabilitation with online support: Participants will be given written educational material, in which the physiotherapist marks the exercises specifically recommended for the individual patient. In addition, participants will get a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants will complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
57.8 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeks for part 1 and 20 weeks for part 2Population: This was the number of women who were eligible and invited to participate.
This outcome represent the number and proportion (%) of eligible patients who consented to participate in the study. Recruitment was open for 10 weeks for participants in Part 1 and for 20 weeks for participants in Part 2.
Outcome measures
| Measure |
Part 1: Home-based Rehabilitation
n=44 Participants
Home-based upper-body rehabilitation with online support
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
Part 2: Home-based Rehabilitation
n=28 Participants
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
|---|---|---|
|
Recruitment Rate
|
35 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: 12 weeksParticipants who are enrolled in the study but fail to complete the end of study assessment will be recorded as dropouts. Feasibility will be defined as a drop out of \<10%
Outcome measures
| Measure |
Part 1: Home-based Rehabilitation
n=35 Participants
Home-based upper-body rehabilitation with online support
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
Part 2: Home-based Rehabilitation
n=24 Participants
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
|---|---|---|
|
Retention
|
29 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: This is the number of participants in part 1 and part 2 who completed the study and who's data was analyzed.
At the end of the study data describing participant satisfaction will be collected to answers questions on acceptability. All participants in part 1 and part 2 will be given a questionnaire, delivered by Easy Research, and will be asked to rank various aspects of the intervention such as the home-based exercises supported by videos, mode of delivery, software, etc. "as not at all satisfied", "not very satisfied", "somewhat satisfied" or "very satisfied". Feasibility will be defined as \>75% of participants reporting they are "very" or "somewhat satisfied" with the intervention.
Outcome measures
| Measure |
Part 1: Home-based Rehabilitation
n=29 Participants
Home-based upper-body rehabilitation with online support
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
Part 2: Home-based Rehabilitation
n=20 Participants
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
|---|---|---|
|
Number of Participants Reporting Being "Very Satisfied" or "Somewhat Satisfied" With the Program
|
16 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The data on capacity was only collected for Part 1 participants and not for part 2.
The amount of time spent with each participant during the standard upper-body assessments, instruction of the home-based intervention and assistance needed with using the website during the study period will be tracked. In addition, any additional appointments required to teach the home-based rehabilitation program or to assist in using the website will be recorded. This information will help to determine the resources needed to administer the online component of the home-based program on a larger scale to a broader group of participants. This data was only collected for Part 1.
Outcome measures
| Measure |
Part 1: Home-based Rehabilitation
n=29 Participants
Home-based upper-body rehabilitation with online support
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
Part 2: Home-based Rehabilitation
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
|---|---|---|
|
Capacity/ Resources
|
92.4 minutes
Standard Deviation 27.1
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: This is the number of participants in part 1 and part 2 who completed the study and who's data was analysed.
Participants in part 1 and part 2 were asked to perform the rehabilitation program at least four times weekly for the duration of the study (12 weeks). Adherence was calculated as the number and proportion of participants who reported in a follow-up questionnaire that they had performed four or more weekly sessions. As such, participants who reported to have completed the home-based rehabilitation program 4 times per week were categorized as having adhered to the program. Likewise, participants who reported to have completed the program 3 times or fewer per week were categorized as not having adhered to the program.
Outcome measures
| Measure |
Part 1: Home-based Rehabilitation
n=29 Participants
Home-based upper-body rehabilitation with online support
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
Part 2: Home-based Rehabilitation
n=20 Participants
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
|---|---|---|
|
Adherence
|
21 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: In part 1, the subscale "Intention" had too low internal consistency to be included in the analysis. No results are therefore reported for this group.
To answers questions on motivation, the participants' reaction to the intervention, intend to use, and perceived appropriateness of the rehabilitation exercises will be answered. Behavioral changes in motivation to do home-based rehabilitation exercises will be measured as this is fundamental to adherence. The study method is theoretically based in the framework of Theory of Planned Behavior and has been validated in measuring motivation for exercise among cancer survivors including breast cancer patients. The Intention, Attitude and Subjective Norm Questionnaire is a 19-item Theory of Planned Behavior questionnaire modified for use with online home-based rehabilitation. All questions are answered using a 7 point Likert scale and produces effect sizes (Cohen's D). The Theory of Planned Behavior scale is scored on a 0 to 7 scale with a higher score indicating a greater level of motivation.
Outcome measures
| Measure |
Part 1: Home-based Rehabilitation
n=29 Participants
Home-based upper-body rehabilitation with online support
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
Part 2: Home-based Rehabilitation
n=20 Participants
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
|---|---|---|
|
Motivation for Rehabilitation Exercises
Planning
|
5.69 score on a scale
Standard Deviation 1.91
|
5.16 score on a scale
Standard Deviation 2.00
|
|
Motivation for Rehabilitation Exercises
Instrumental attitude
|
6.45 score on a scale
Standard Deviation 0.54
|
6.38 score on a scale
Standard Deviation 0.42
|
|
Motivation for Rehabilitation Exercises
Affective attitude
|
4.82 score on a scale
Standard Deviation 1.09
|
4.45 score on a scale
Standard Deviation 1.15
|
|
Motivation for Rehabilitation Exercises
Self-efficacy
|
5.90 score on a scale
Standard Deviation 1.46
|
5.46 score on a scale
Standard Deviation 1.48
|
|
Motivation for Rehabilitation Exercises
Perceived behavioral control
|
6.09 score on a scale
Standard Deviation 1.21
|
5.26 score on a scale
Standard Deviation 1.48
|
|
Motivation for Rehabilitation Exercises
Intention
|
—
|
6.20 score on a scale
Standard Deviation 1.12
|
|
Motivation for Rehabilitation Exercises
Subjective norm
|
6.34 score on a scale
Standard Deviation 0.97
|
5.90 score on a scale
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: A 3-level categorical outcome was applied (not limited, moderately limited, greatly limited).
Active shoulder mobility for flexion and external rotation. Changes from baseline to follow-up (12 weeks later) will be calculated. This data was only collected for participants in part 1.
Outcome measures
| Measure |
Part 1: Home-based Rehabilitation
n=35 Participants
Home-based upper-body rehabilitation with online support
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
Part 2: Home-based Rehabilitation
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
|---|---|---|
|
Clinical Outcomes in Upper-body Function: Mobility
Baseline: Flexion · Not limited
|
19 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Mobility
Baseline: Flexion · Moderately limited
|
13 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Mobility
Baseline: Flexion · Greatly limited
|
1 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Mobility
Baseline: Flexion · Missing
|
2 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Mobility
End of study: Flexion · Not limited
|
27 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Mobility
End of study: Flexion · Moderately limited
|
1 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Mobility
End of study: Flexion · Greatly limited
|
0 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Mobility
End of study: Flexion · Missing
|
1 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Mobility
Baseline: External rotation · Not limited
|
17 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Mobility
Baseline: External rotation · Moderately limited
|
11 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Mobility
Baseline: External rotation · Greatly limited
|
3 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Mobility
Baseline: External rotation · Missing
|
4 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Mobility
End of study: External rotation · Not limited
|
21 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Mobility
End of study: External rotation · Moderately limited
|
6 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Mobility
End of study: External rotation · Greatly limited
|
1 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Mobility
End of study: External rotation · Missing
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: A 3-level categorical outcome was applied (not limited, moderately limited, greatly limited).
Upper body muscle strength was tested using Manual Muscle Testing among participants in part 1 only.
Outcome measures
| Measure |
Part 1: Home-based Rehabilitation
n=35 Participants
Home-based upper-body rehabilitation with online support
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
Part 2: Home-based Rehabilitation
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
|---|---|---|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
End of study: Pectoralis Major · Missing
|
4 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
Baseline: Latissimus Dorsi · Not limited
|
25 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
Baseline: Latissimus Dorsi · Moderately limited
|
9 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
Baseline: Latissimus Dorsi · Greatly limited
|
0 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
Baseline: Latissimus Dorsi · Missing
|
1 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
End of study: Latissimus Dorsi · Not limited
|
25 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
End of study: Latissimus Dorsi · Moderately limited
|
1 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
End of study: Latissimus Dorsi · Greatly limited
|
0 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
End of study: Latissimus Dorsi · Missing
|
3 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
Baseline: Serratus Anterior · Not limited
|
16 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
Baseline: Serratus Anterior · Moderately limited
|
13 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
Baseline: Serratus Anterior · Greatly limited
|
1 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
Baseline: Serratus Anterior · Missing
|
5 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
End of study: Serratus Anterior · Not limited
|
16 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
End of study: Serratus Anterior · Moderately limited
|
10 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
End of study: Serratus Anterior · Greatly limited
|
1 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
End of study: Serratus Anterior · Missing
|
2 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
Baseline: Pectoralis Major · Not limited
|
13 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
Baseline: Pectoralis Major · Moderately limited
|
18 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
Baseline: Pectoralis Major · Greatly limited
|
0 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
Baseline: Pectoralis Major · Missing
|
4 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
End of study: Pectoralis Major · Not limited
|
17 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
End of study: Pectoralis Major · Moderately limited
|
8 Participants
|
0 Participants
|
|
Clinical Outcomes in Upper-body Function: Muscle Strength
End of study: Pectoralis Major · Greatly limited
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Handling errors compromised data integrity. Specifically, data was not collected at the end of study time point. This prohibited reporting and analysis of data.
Arm circumference at 5 points along the arm. Changes from baseline will be calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants in part 2 did not have a clinical assessment at follow up and this data is therefore not collected for part 2, but only collected for part 1.
Patient-reported pain on a 0-10 Visual Analogue Scale in the breast/arm region. A higher score indicates greater level of pain. Changes from baseline will be calculated. This data was only collected for part 1.
Outcome measures
| Measure |
Part 1: Home-based Rehabilitation
n=35 Participants
Home-based upper-body rehabilitation with online support
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
Part 2: Home-based Rehabilitation
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
|---|---|---|
|
Clinical Outcomes in Upper-body Function: Pain
Baseline
|
1.0 score on a scale
Interval 1.0 to 3.0
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—
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Clinical Outcomes in Upper-body Function: Pain
Follow up
|
1.0 score on a scale
Interval 1.0 to 2.0
|
—
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SECONDARY outcome
Timeframe: 12 weeksPopulation: At baseline, 35 participants in part 1 and 20 participants in part 2 completed the QuickDASH questionnaire. At follow-up, 24 participants in part 1 and 17 participants in part 2 completed the questionnaire.
QuickDASH (Disabilities of the Arm, Shoulder, and Hand) scores 0 to 100 with higher scores indicating more limitations in upper-body functioning.
Outcome measures
| Measure |
Part 1: Home-based Rehabilitation
n=35 Participants
Home-based upper-body rehabilitation with online support
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
|
Part 2: Home-based Rehabilitation
n=20 Participants
Participants in both Part 1 and Part 2 received the same home-based upper-body rehabilitation with online support: Participants received written educational material, in which the physiotherapist marked the exercises specifically recommended for the individual patient. In addition, participants were provided with a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
On average, participants were asked to complete three rehabilitation exercises a minimum of 4 times weekly with an anticipated duration of approximately 20 minutes.
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|---|---|---|
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Ability to Perform Activities of Daily Living
Baseline
|
19.8 score on a scale
Standard Deviation 13.3
|
13.5 score on a scale
Standard Deviation 15.8
|
|
Ability to Perform Activities of Daily Living
Follow up
|
15.2 score on a scale
Standard Deviation 14.8
|
11.0 score on a scale
Standard Deviation 8.2
|
Adverse Events
Part 1: Home-based Rehabilitation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2: Home-based Rehabilitation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place