Breast CancerRACERNCT03702712
Responsiveness to Acute Changes in Exercise and Relaxation (RACER) Trial
A study testing Aerobic Exercise and Relaxation, Aerobic Exercise Only and Relaxation Only in people with Breast Cancer, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The purpose of this acute study is to compare the combined effects of aerobic exercise and relaxation training on fatigue and its related cognitive components, among breast cancer survivors. Participants will complete three sessions over a seven-day period in a laboratory setting. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Aerobic Exercise and Relaxation, Aerobic Exercise Only and Relaxation Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 120 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- previously diagnosed with breast cancer (ductal carcinoma in situ or stages I-IV)
- completed at least one cycle of chemotherapy treatment within the last 5 years
- must have reliable access to the internet
- must report at least one complaint concerning physical function, fatigue, memory, planning, thinking, negative mood, depressive symptoms, or anxiety
- must be capable of engaging in sustained stationary cycling at a moderate intensity
Who cannot join
- deaf in both ears
- unable to comfortably wear a pair of ear-bud headphones
- color-blind or do not have vision of at least 20/40 with the aid of contacts or glasses
- history or diagnosis of epilepsy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: Acute Effects of Aerobic Exercise and Relaxation on Fatigue and Executive Function in Breast Cancer Survivors
The purpose of this acute study is to compare the combined effects of aerobic exercise and relaxation training on fatigue and its related cognitive components, among breast cancer survivors. Participants will complete three sessions over a seven-day period in a laboratory setting.
Read the detailed description
It is hypothesized that the combination of aerobic exercise and relaxation training could have additive effects on fatigue and related cognitive outcomes. Therefore, this study is designed to test the effects of exercise plus relaxation relative to aerobic exercise alone and relaxation training alone, over the course of three sessions within a seven day period. Participants will complete baseline and post-testing before and after the week of training, as well as pre- and post-testing at each session.
Participants will be randomized to one of three conditions:
- Aerobic Exercise Only Condition (AERO) Participants randomized to the AERO condition will engage in three separate 20-minute sessions comprised of a 5-minute, resistance-free warm-up, and 15 minutes of moderate aerobic cycling on a stationary bike (50-70% age-predicted heart rate max). Each AERO session will end with a 20-minute quiet rest period.
- Relaxation Only Condition (RELAX) Participants in the RELAX condition will complete three separate 20-minute sessions of relaxation training using a commercial neurofeedback device (headset \& smartphone app). Each RELAX session will end with a 20-minute quiet rest period.
- Aerobic Exercise and Relaxation Training - Intervention Condition (COMBINED) Participants randomized to the COMBINED condition will complete three separate sessions comprised of 20 minutes of AERO exercise followed by 20 minutes of RELAX training.
All participants, regardless of condition will complete brief questionnaires assessing in-the-moment fatigue and affect, before and after each randomly assigned activity session. A larger survey and battery of cognitive tests will be completed at the beginning of the first appointment and at the conclusion of the third appointment.
- Conditions
- Breast Cancer
- Being tested
- Aerobic Exercise and Relaxation, Aerobic Exercise Only, Relaxation Only
- Keywords
- Survivorship, Fatigue, Relax, Cognition, Exercise
- Medical subject headings
- Breast Neoplasms, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise and RelaxationBehavioural
This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of mindfulness training.
Aerobic Exercise OnlyBehavioural
This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of quiet rest.
Relaxation OnlyBehavioural
This intervention will combine 20 minutes of mindfulness-based relaxation training followed by 20 minutes of quiet rest.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Only | Active comparator | Participants in the Aerobic Exercise Only arm will engage in three separate 20-minute sessions comprised of a 5-minute, resistance-free warm-up, and 15 minutes of moderate stationary aerobic cycling on a Cybex bike #525C (50-70% age-predicted heart rate max). Each session will be followed by 20 minutes of uninterrupted quiet rest. The bike will provide feedback including speed, rotations per minute, and time. Receives: Behavioral: Aerobic Exercise Only |
| Relaxation Only | Active comparator | Participants in the Relaxation Only arm will complete three separate 20-minute sessions of relaxation using a commercial wearable neurofeedback (headband) device. The device's accompanying software (connected to the headband through Bluetooth) encourages breathing strategies in response to recorded brain wave activity. Real time auditory feedback includes sounds of calm (soft) or loud winds in response to detected brain activity. A visual report of affective states and the user's brain activity is given (alpha and beta waves). Participants will also be asked to take part in 20 minutes of uninterrupted quiet rest in order to match the time of the aerobic only condition. Receives: Behavioral: Relaxation Only |
| Aerobic Exercise and Relaxation | Experimental | Participants in the Aerobic Exercise and Relaxation arm will complete the three separate 20-minute aerobic exercise sessions (identical to the aerobic exercise only condition) followed by the same 20-minute neurofeedback-guided mindfulness training (identical to the relaxation only condition). Receives: Behavioral: Aerobic Exercise and Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Piper Fatigue Scale
The Piper Fatigue Scale requires respondents to select their answers according to a "0" (most positive or desirable response) to "10" (most negative, fatigue is having a strong impact) scale. A total fatigue score is calculated by summing each of the 12 responses and dividing by 12. Accordingly, a total fatigue change score of 0 corresponds to no fatigue, a score of 1-3 is labeled as mild, 4-6 is labeled as moderate, and 7-10 is labeled as severe. The total scores from each of the three days will be used to calculate an overall fatigue score, which will be used to assess group level differences across averages. Our operational definition of overall fatigue in this outcome is the average score across each group.
Measured: This will be assessed on day 1 (baseline), day 2 and day 3 (post-testing), both before and after randomized activities.
Secondary outcomes (11)
Perceived Mental Fatigue
The Perceived Mental Fatigue Questionnaire (PMFQ) is a novel inventory using 7-item Likert scale ( e.g., "My thinking requires effort," 1 = Not at all to 5 = Very true). Participants are asked to reflect on their current level of mental fatigue. The 7 items from PMFQ are summed together to create a composite fatigue value. The total scores from each of the three days will be used to calculate an overall fatigue score, which will be used to assess group level differences across averages. Our operational definition of overall fatigue in this outcome is the average score across each group.
Measured: The PMFQ will be assessed on day 1 (baseline), day 2, and day 3 (post-testing).
Energy subscale of AD ACL-SAI
The AD ACL-SAI asks respondents to select how they relate to a specific adjective in the moment by choosing between 4 answer options (1=not at all, 2=moderately so, 3=somewhat, and 4=very much so). Each of the 5 items in the Energy subscale are summed together to create an overall Energy fatigue score.The total scores from each of the three days will be used to calculate an overall energy score, which will be used to assess group level differences across averages. Our operational definition of overall energy in this outcome is the average score across each group.
Measured: This will be assessed following randomized activities on Day 1 (baseline), Day 2, and Day 3 (post-testing).
Tiredness subscale of AD ACL-SAI
The AD ACL-SAI asks respondents to select how they relate to a specific adjective in the moment by choosing between 4 answer options (1=not at all, 2=moderately so, 3=somewhat, and 4=very much so). Each of the 5 items in the Tiredness subscale are summed together to create an overall Tiredness fatigue score. This will be used to calculate a change score. The total scores from each of the three days will be used to calculate an overall tiredness score, which will be used to assess group level differences across averages. Our operational definition of overall tiredness in this outcome is the average score across each group.
Measured: This will be assessed following randomized activities on Day 1 (baseline), Day 2, and Day 3 (post-testing).
Attention- Assessed by Flanker Inhibitory Control and Attention task from the NIH toolbox
In the Flanker task participants focus on a given stimulus while inhibiting attention to stimuli flanking it. Participants see a row of 5 arrows and choose the button that matches the direction the middle arrow is pointing. This test yields a standardized accuracy and processing speed change score.
Measured: This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
Working Memory- Assessed by Picture Sequence task from the NIH toolbox
The Picture Sequence tasks asks participants to remember a specific order of events as demonstrated by the task itself on a screen. At the conclusion of the demonstration, the events are scrambled and the participants are instructed to place them back in the correct order. This task yields a standardized accuracy change score.
Measured: This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
Cognitive Flexibility and Attention- Assessed by Dimensional Change Card Sort Task from the NIH toolbox
In the Dimensional Change Card Sort Task, participants are asked to match a series of bivalent test pictures (e.g., yellow balls and blue trucks) to the target pictures, first according to one dimension (e.g., color) and then, after a number of trials, according to the other dimension (e.g., shape). The ensuing "switch" trials are also employed, in which the participant is required to change the dimension being matched. For example, after 4 straight trials matching on shape, the participant may be asked to match on color on the next trial and then go back to shape, thus requiring the cognitive flexibility to quickly choose the correct stimulus. The NIH toolbox automatically calculates an overall raw score, which takes into account both accuracy and reaction time, used to create a change score.
Measured: This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
Program Evaluation - Perceived Usefulness
All participants will complete an adapted version of Davis (1989) and Davis et al., (1989) perceived usefulness questionnaire (e.g., "Using the technology-delivered relaxation training program improved my thinking"). These 5 items will be measured using a 7-point Likert scale (1 = Strongly disagree, 4 = Neutral, 7 = Strongly agree) and will assess attitudes towards the technology-delivered relaxation-training program. The 5 item's responses will be averaged and then used for a total perceived usefulness score.
Measured: This will be assessed on day 3.
Program Evaluation - Perceived Ease of Use
All participants will complete an adapted version of Davis (1989) and Davis et al., (1989) perceived ease of use questionnaire (e.g., "I found the technology-delivered relaxation training program to be easy to use"). These 5 items will be measured using a 7-point Likert scale (1 = Strongly disagree, 4 = Neutral, 7 = Strongly agree) and will assess attitudes towards the technology-delivered relaxation-training program. The 5 item's responses will be averaged and then used for a total perceived usefulness score.
Measured: This will be assessed on day 3.
Program Evaluation - Enjoyment
An evaluation of participants' enjoyment of the trial will also be included. Five questions (e.g., I enjoyed using the mindfulness training device) using a 7-point Likert scale (1 = Not at all, 4 = Neutral, 7 = Completely) will be administered. The 5 item's responses will be averaged and then used for a total perceived usefulness score.
Measured: This will be assessed on day 3.
Program Evaluation - Satisfaction
An evaluation of participants' satisfaction with components of the trial will also be included. Five questions (e.g., I am satisfied with the outcomes experienced following mindfulness training) using a 7-point Likert scale (1 = Not at all, 4 = Neutral, 7 = Completely) will be administered. The 5 item's responses will be averaged and then used for a total perceived usefulness score.
Measured: This will be assessed on day 3.
Program Evaluation - Open Ended
An open ended evaluation of participants' experience with the trial will also be included. This qualitative question will ask participants to expand upon their overall likes and dislikes, recommendations, and modifications will be included. Open ended responses will be used to design and apply future interventions in this area.
Measured: This will be assessed on day 3.- focusing on thoughts of the program over the three appointment days, in a 1-week period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start15 Oct 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Mullen, University of Illinois at Urbana-Champaign
- Investigators
- Sean P Mullen, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702712
- Sponsor's protocol ID
- 16381
- Acronym
- RACER
- Status last verified
- Apr 2019
- First submitted
- 3 Oct 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data will be made available for all primary and secondary outcome measures. Included documentation will be comprised of study protocol, statistical analyses protocols, informed consent documentation, and layperson research procedures. Additionally information will be made available upon request. Data access requests will be reviewed by the primary investigators. Requestors will be required to sign a Data Access Agreement.
Publications
Cohen J, Rogers WA, Petruzzello S, Trinh L, Mullen SP. Acute effects of aerobic exercise and relaxation training on fatigue in breast cancer survivors: A feasibility trial. Psychooncology. 2021 Feb;30(2):252-259. doi: 10.1002/pon.5561. Epub 2020 Oct 14.
PubMed 33010183
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Aerobic Exercise and Relaxation on Fatigue and Executive Function in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03702712
- Acronym / sponsor ID
- RACER / 16381
- Conditions
- Breast Cancer
- Keywords
- Survivorship, Fatigue, Relax, Cognition, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 11 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this acute study is to compare the combined effects of aerobic exercise and relaxation training on fatigue and its related cognitive components, among breast cancer survivors. Participants will complete three sessions over a seven-day period in a laboratory setting.
Detailed description
It is hypothesized that the combination of aerobic exercise and relaxation training could have additive effects on fatigue and related cognitive outcomes. Therefore, this study is designed to test the effects of exercise plus relaxation relative to aerobic exercise alone and relaxation training alone, over the course of three sessions within a seven day period. Participants will complete baseline and post-testing before and after the week of training, as well as pre- and post-testing at each session.
Participants will be randomized to one of three conditions:
- Aerobic Exercise Only Condition (AERO) Participants randomized to the AERO condition will engage in three separate 20-minute sessions comprised of a 5-minute, resistance-free warm-up, and 15 minutes of moderate aerobic cycling on a stationary bike (50-70% age-predicted heart rate max). Each AERO session will end with a 20-minute quiet rest period.
- Relaxation Only Condition (RELAX) Participants in the RELAX condition will complete three separate 20-minute sessions of relaxation training using a commercial neurofeedback device (headset \& smartphone app). Each RELAX session will end with a 20-minute quiet rest period.
- Aerobic Exercise and Relaxation Training - Intervention Condition (COMBINED) Participants randomized to the COMBINED condition will complete three separate sessions comprised of 20 minutes of AERO exercise followed by 20 minutes of RELAX training.
All participants, regardless of condition will complete brief questionnaires assessing in-the-moment fatigue and affect, before and after each randomly assigned activity session. A larger survey and battery of cognitive tests will be completed at the beginning of the first appointment and at the conclusion of the third appointment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Only | Active comparator | Behavioral: Aerobic Exercise OnlyParticipants in the Aerobic Exercise Only arm will engage in three separate 20-minute sessions comprised of a 5-minute, resistance-free warm-up, and 15 minutes of moderate stationary aerobic cycling on a Cybex bike #525C (50-70% age-predicted heart rate max). Each session will be followed by 20 minutes of uninterrupted quiet rest. The bike will provide feedback including speed, rotations per minute, and time. |
| Relaxation Only | Active comparator | Behavioral: Relaxation OnlyParticipants in the Relaxation Only arm will complete three separate 20-minute sessions of relaxation using a commercial wearable neurofeedback (headband) device. The device's accompanying software (connected to the headband through Bluetooth) encourages breathing strategies in response to recorded brain wave activity. Real time auditory feedback includes sounds of calm (soft) or loud winds in response to detected brain activity. A visual report of affective states and the user's brain activity is given (alpha and beta waves). Participants will also be asked to take part in 20 minutes of uninterrupted quiet rest in order to match the time of the aerobic only condition. |
| Aerobic Exercise and Relaxation | Experimental | Behavioral: Aerobic Exercise and RelaxationParticipants in the Aerobic Exercise and Relaxation arm will complete the three separate 20-minute aerobic exercise sessions (identical to the aerobic exercise only condition) followed by the same 20-minute neurofeedback-guided mindfulness training (identical to the relaxation only condition). |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years and older
- previously diagnosed with breast cancer (ductal carcinoma in situ or stages I-IV)
- completed at least one cycle of chemotherapy treatment within the last 5 years
- must have reliable access to the internet
- must report at least one complaint concerning physical function, fatigue, memory, planning, thinking, negative mood, depressive symptoms, or anxiety
Key exclusion criteria (4 listed)
- deaf in both ears
- unable to comfortably wear a pair of ear-bud headphones
- color-blind or do not have vision of at least 20/40 with the aid of contacts or glasses
- history or diagnosis of epilepsy
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 |
|---|---|---|
| Aerobic Exercise and RelaxationThis intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of mindfulness training. | Behavioural | Aerobic Exercise and Relaxation |
| Aerobic Exercise OnlyThis intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of quiet rest. | Behavioural | Aerobic Exercise Only |
| Relaxation OnlyThis intervention will combine 20 minutes of mindfulness-based relaxation training followed by 20 minutes of quiet rest. | Behavioural | Relaxation Only |
Primary outcome
Piper Fatigue Scale
Time frame: This will be assessed on day 1 (baseline), day 2 and day 3 (post-testing), both before and after randomized activities.
The Piper Fatigue Scale requires respondents to select their answers according to a "0" (most positive or desirable response) to "10" (most negative, fatigue is having a strong impact) scale. A total fatigue score is calculated by summing each of the 12 responses and dividing by 12. Accordingly, a total fatigue change score of 0 corresponds to no fatigue, a score of 1-3 is labeled as mild, 4-6 is labeled as moderate, and 7-10 is labeled as severe. The total scores from each of the three days will be used to calculate an overall fatigue score, which will be used to assess group level differences across averages. Our operational definition of overall fatigue in this outcome is the average score across each group.
11 secondary outcomes
Perceived Mental Fatigue
Time frame: The PMFQ will be assessed on day 1 (baseline), day 2, and day 3 (post-testing).
Energy subscale of AD ACL-SAI
Time frame: This will be assessed following randomized activities on Day 1 (baseline), Day 2, and Day 3 (post-testing).
Tiredness subscale of AD ACL-SAI
Time frame: This will be assessed following randomized activities on Day 1 (baseline), Day 2, and Day 3 (post-testing).
Attention- Assessed by Flanker Inhibitory Control and Attention task from the NIH toolbox
Time frame: This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
Working Memory- Assessed by Picture Sequence task from the NIH toolbox
Time frame: This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
Cognitive Flexibility and Attention- Assessed by Dimensional Change Card Sort Task from the NIH toolbox
Time frame: This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
Program Evaluation - Perceived Usefulness
Time frame: This will be assessed on day 3.
Program Evaluation - Perceived Ease of Use
Time frame: This will be assessed on day 3.
Program Evaluation - Enjoyment
Time frame: This will be assessed on day 3.
Program Evaluation - Satisfaction
Time frame: This will be assessed on day 3.
Program Evaluation - Open Ended
Time frame: This will be assessed on day 3.- focusing on thoughts of the program over the three appointment days, in a 1-week period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Derived from this study: PubMed 33010183Cohen J, Rogers WA, Petruzzello S, Trinh L, Mullen SP. Acute effects of aerobic exercise and relaxation training on fatigue in breast cancer survivors: A feasibility trial. Psychooncology. 2021 Feb;30(2):252-259. doi: 10.1002/pon.5561. Epub 2020 Oct 14.
- Exercise, Technology, and Cognition LaboratoryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified participant data will be made available for all primary and secondary outcome measures. Included documentation will be comprised of study protocol, statistical analyses protocols, informed consent documentation, and layperson research procedures. Additionally information will be made available upon request. Data access requests will be reviewed by the primary investigators. Requestors will be required to sign a Data Access Agreement.
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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.
Sean P Mullen, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Relaxation, Aerobic Exercise Only and Relaxation Only in people with Breast Cancer, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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 6 inclusion and 4 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Piper Fatigue Scale (time frame: This will be assessed on day 1 (baseline), day 2 and day 3 (post-testing), both before and after randomized activities.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03702712, which also lists 1 linked publication.
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 16 Apr 2019.