Cancer-related FatigueNCT03049384
Tailored Exercise Interventions to Reduce Fatigue in Cancer Survivors
A study testing Traditional Exercise and Tailored Exercise in people with Cancer-related Fatigue, run by University of Calgary at 1 site in Canada.
Trial summary
Cancer-related fatigue (CRF) is a common and distressing symptom of cancer and/or cancer treatment that can persist for months or years in cancer survivors. Exercise is beneficial for the management of CRF, and general exercise guidelines for cancer survivors are available. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer-related Fatigue
- What is being tested?
- Traditional Exercise and Tailored Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- 9 Mar 2017to 31 Mar 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 75 years;
- Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score ≤ 34;
- Completion of treatment in ≥ 3 months and ≤ 5 years preceding enrollment;
- Approval received from personal physician and/or a Canadian Society for Exercise Physiology-Clinical Exercise Physiologist (CSEP-CEP);
- Command of the English language.
Who cannot join
- Contraindication to experimental procedures including transcranial magnetic stimulation (TMS);
- Diagnosed as having obstructive sleep apnea or anemia;
- Currently participating in a structured exercise intervention;
- Participant is pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Cancer-related fatigue (CRF) is a common and distressing symptom of cancer and/or cancer treatment that can persist for months or years in cancer survivors. Exercise is beneficial for the management of CRF, and general exercise guidelines for cancer survivors are available. However, exercise interventions have not been tailored to alleviate CRF in fatigued cancer survivors, and thus the potential to alleviate CRF may not have been realized. The primary aim of this research is to investigate the effect of a traditional vs. tailored 12-week exercise intervention on self-reported CRF severity.
Read the detailed description
Background and Rationale
Approximately one-third of cancer survivors experience severe and persistent fatigue for a number of years post-treatment, but this distressing symptom is often under-treated by healthcare professionals due to a lack of mechanism-targeted interventions. The assessment of cancer-related fatigue (CRF) is reliant on subjective fatigue measurements such as self-report questionnaires. Less attention has been given to objective physiological measurements. However, there are well-established techniques which allow the assessment of neuromuscular fatigue and its peripheral and central origins which could be utilized in the study of CRF. Very few studies have considered these objective measures alongside self-report scales in the study of CRF and only two have used such techniques in cancer survivors. To date, no studies have investigated neuromuscular fatigue in whole body, dynamic activity as relevant to daily tasks (and involving the lower limb due to its functional relevance to locomotion). Novel testing developed in our laboratory could be used as part of a wider screening to develop individualized interventions to alleviate CRF. It is well accepted in the field that CRF is multidimensional and in addition to a potential neuromuscular component, the role of sleep disturbance may also be implicated. Interventions targeted at improving sleep quality are therefore warranted, and there is sound evidence for the efficacy of exercise interventions in particular for improving CRF in cancer survivors. As a non-pharmacological intervention, physical activity has the strongest evidence base for treating CRF. However, the mechanisms explaining the reduction of CRF with exercise are not understood. Due to the complex and multi-factorial nature of CRF, it would be of benefit to tailor exercise interventions to the specific deficits (in regards to neuromuscular mechanisms) or difficulties (for example sleep disturbance) experienced by the individual. Ultimately, mechanism-targeted exercise interventions could be translated to clinical rehabilitation programs and lead to an improved quality of for cancer survivors.
Research Question \& Objectives
The primary aim of this research is to investigate the effect of a traditional vs. tailored 12-week exercise intervention on self-reported CRF severity.
Methods
Fatigued cancer survivors who have completed primary treatment ≥ 3 months and ≤ 5 years from enrollment will be randomly allocated to one of two treatment arms: traditional (active control) and tailored exercise. Participants in the traditional exercise group will engage in aerobic and resistance exercise that is consistent with published recommendations. The tailored exercise group will be prescribed an intervention designed to address individual deficits (identified at baseline) that may be related to CRF. Participants will be assessed before and after the intervention for patient-reported outcomes, neuromuscular function and fatigue in response to whole-body exercise, sleep quantity and quality, physical activity levels, cardiorespiratory fitness and blood biomarkers.
- Conditions
- Cancer-related Fatigue
- Being tested
- Traditional Exercise, Tailored Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional ExerciseOther
The traditional exercise group will undertake a supervised exercise intervention involving aerobic exercise and light resistance training, in line with published guidelines for exercise in cancer survivors.
Tailored ExerciseOther
The tailored training group will be prescribed an individualized exercise intervention designed specifically to counteract deficits (e.g. neuromuscular) of difficulties (e.g. sleep disturbance) identified during pre-intervention testing.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Exercise | Active comparator | A classical exercise intervention based on current guidelines for cancer survivors. Receives: Other: Traditional Exercise |
| Tailored Exercise | Experimental | A tailored and individualized exercise intervention based on the results of pre-intervention testing. Receives: Other: Tailored Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale
Self-report questionnaire for the assessment of cancer-related fatigue.
Measured: Baseline to after the 12-week intervention, at 6 month and 12 month follow up.
Secondary outcomes (43)
Assessment of change in The Functional Assessment of Cancer Therapy - General (FACT-G)
General quality of life instrument intended for use with a variety of chronic illness conditions.
Measured: Baseline and after the 12-week intervention.
Assessment of change in Edmonton Symptom Assessment System-revised tiredness scale
Self-report questionnaire for the assessment of of nine common symptoms experienced by cancer patients.
Measured: Baseline and after the 12-week intervention, and during follow up (6 and 12 months).
Maximal Isometric Force in the Knee Extensors
A reduction in maximal isometric force in the knee extensors measured before, during and after an intermittent cycling test.
Measured: Baseline and after the 12-week intervention.
Cortical Voluntary Activation
A reduction voluntary activation (using transcranial magnetic stimulation) measured measured before, during and after an intermittent cycling test.
Measured: Baseline and after the 12-week intervention.
Voluntary Activation
A reduction voluntary activation (using femoral nerve stimulation) measured before, during and after an intermittent cycling test.
Measured: Baseline and after the 12-week intervention.
Potentiated Doublet Twitch Force
A reduction in potentiated quadriceps twitch force (from a high frequency doublet at 100 Hz) measured before, before, during and after an intermittent cycling test.
Measured: Baseline and after the 12-week intervention.
Muscle Compound Action Potential (M-Wave) Peak-to Peak Amplitude
Evoked from supra-maximal stimulation of the femoral nerve and measured before, during and after an intermittent cycling test.
Measured: Baseline and after the 12-week intervention.
Muscle Compound Action Potential (M-Wave) Peak-to Peak Duration
Evoked from supra-maximal stimulation of the femoral nerve and measured before, during and after an intermittent cycling test.
Measured: Baseline and after the 12-week intervention.
Muscle Compound Action Potential (M-Wave) Area
Evoked from supra-maximal stimulation of the femoral nerve and measured before, during and after an intermittent cycling test.
Measured: Baseline and after the 12-week intervention.
Motor Evoked Potential (MEP) Peak-to Peak Amplitude
Normalized to the maximal M-wave and measured before, during and after an intermittent cycling test.
Measured: Baseline and after the 12-week intervention.
Motor Evoked Potential (MEP) Peak-to Peak Duration
Normalized to the maximal M-wave and measured before, during and after an intermittent cycling test.
Measured: Baseline and after the 12-week intervention.
Motor Evoked Potential (MEP) Area
Normalized to the maximal M-wave and measured before, during and after an intermittent cycling test.
Measured: Baseline and after the 12-week intervention.
Cortical Silent Period
Evoked from TMS and measured (from stimulation artifact to the continuous resumption of EMG) before, during and after an intermittent cycling test.
Measured: Baseline and after the 12-week intervention.
Voluntary Electromyography (EMG)
Root mean square of the EMG signal during an MVC, measured before, during and after an intermittent cycling test.
Measured: Baseline and after the 12-week intervention.
Amplitude of the Sleep-Wake Cycle
The mean difference between lowest and highest activity period, recorded with actigraphy.
Measured: Baseline and after the 12-week intervention.
Peak Time of the sleep-wake Cycle
Time of day of the highest estimated level of wake, recorded by actigraphy.
Measured: Baseline and after the 12-week intervention.
Mesor of the Sleep-Wake Cycle
Mean level of activity over 24 hours, recorded with actigraphy.
Measured: Baseline and after the 12-week intervention.
inter-daily stability
the degree of regularity of the rest-activity patterns on individual days in the 24 h environment, recorded with actigraphy.
Measured: Baseline and after the 12-week intervention.
intra-daily variability
the fragmentation of periods of rest and activity, recorded with actigraphy.
Measured: Baseline and after the 12-week intervention.
L5
The mean activity counts in the least active 5 h period in the average 24 h pattern) recorded with actigraphy.
Measured: Baseline and after the 12-week intervention.
L5 mid
The central time of the L5 period, usually referring to the through of the activity period), recorded with actigraphy.
Measured: Baseline and after the 12-week intervention.
Wake actigraphy
Amount of activity during wake, recorded with actigraphy
Measured: Baseline and after the 12-week intervention.
Sleep Activity
Amount of activity during sleep periods, recorded with actigraphy
Measured: Baseline and after the 12-week intervention.
Activity Index
Percentage of activity per epoch for wake and sleep, recorded with actigraphy.
Measured: Baseline and after the 12-week intervention.
Time in bed
Time spent between the moment subject turn off the light to sleep and the moment he gets up, recorded with actigraphy.
Measured: Baseline and after the 12-week intervention.
Actual Sleep Time
Time spent asleep during the night, recorded with actigraphy.
Measured: Baseline and after the 12-week intervention.
Actual Wake Time
Time spent awaken during the night, recorded with actigraphy.
Measured: Baseline and after the 12-week intervention.
Sleep Onset Latency
Time to fall asleep, recorded with actigraphy.
Measured: Baseline and after the 12-week intervention.
Sleep Efficiency
Ratio between the time spent asleep and the total duration of sleep period, recorded with actigraphy.
Measured: Baseline and after the 12-week intervention.
Fragmentation index
Indication of the sleep quality based on movement during night, recorded with actigraphy.
Measured: Baseline and after the 12-week intervention.
Blood Biomarkers
Blood count, catecholamines, serotonin, cortisol, inflammatory markers and markers of oxidative stress.
Measured: Baseline and after the 12-week intervention.
Assessment of change in the Centre for Epidemiological Studies Depression Scale (CES-D) questionnaire.
Self-report questionnaire for the assessment of health-related quality of life, specific to cancer type.
Measured: Baseline and after the 12-week intervention.
Assessment of change in The Social Prevision Scale (SPS)
Self-report questionnaire for the assessment of social support.
Measured: Baseline and after the 12-week intervention.
Assessment of change in The Functional Assessment of Cancer Therapy (FACT) Cancer Specific
Self-report questionnaire for the assessment
Measured: Baseline and after the 12-week intervention.
Assessment of change in The Modified-Godin Leisure Time Exercise Questionnaire (GLTEQ)
Self-report questionnaire for the assessment of leisure time physical activity.
Measured: Baseline, after the 12-week intervention, and during follow up (6 and 12 months).
Assessment of change in The Insomnia Severity Index (ISI)
Self-report questionnaire for the assessment of insomnia severity.
Measured: Baseline and after the 12-week intervention.
Assessment of change in The Brief Pain Inventory Short Form (BPI-sf)
Self-report questionnaire for the assessment of pain.
Measured: Baseline and after the 12-week intervention.
Assessment of change in Maximal Oxygen Uptake
The highest 30 second average oxygen uptake measured during an an incremental cycling test.
Measured: Baseline and after the 12-week intervention.
Assessment of change in Muscle Cross-Sectional Area
Ultrasound measurement of the vastus lateralis and rectus femoris.
Measured: Baseline and after the 12-week intervention.
Heart Rate Variability
Variation in the time interval between heartbeats.
Measured: Baseline and after the 12-week intervention.
Assessment of change in Fat Mass
Measured using dual energy X-ray absorptiometry (DXA).
Measured: Baseline and after the 12-week intervention.
Assessment of change in Fat Free Mass
Measured using dual energy X-ray absorptiometry (DXA).
Measured: Baseline and after the 12-week intervention.
Assessment of change in Bone Mineral Density
Measured using dual energy X-ray absorptiometry (DXA).
Measured: Baseline and after the 12-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start9 Mar 2017
- Primary completion31 Mar 2020
- Study completion31 Mar 2021
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 Cancer-related FatigueStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Principal investigator, Guillaume Millet, University of Calgary
- Investigators
- Guillaume Millet, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049384
- Sponsor's protocol ID
- HREBA.CC-16-1010
- Status last verified
- Oct 2021
- First submitted
- 3 Feb 2017
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Twomey R, Martin T, Temesi J, Culos-Reed SN, Millet GY. Tailored exercise interventions to reduce fatigue in cancer survivors: study protocol of a randomized controlled trial. BMC Cancer. 2018 Jul 24;18(1):757. doi: 10.1186/s12885-018-4668-z.
PubMed 30041626
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Exercise Interventions to Reduce Fatigue in Cancer Survivors
- ClinicalTrials.gov ID
- NCT03049384
- Acronym / sponsor ID
- HREBA.CC-16-1010
- Conditions
- Cancer-related Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 10 Feb 2017 (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.
Cancer-related fatigue (CRF) is a common and distressing symptom of cancer and/or cancer treatment that can persist for months or years in cancer survivors. Exercise is beneficial for the management of CRF, and general exercise guidelines for cancer survivors are available. However, exercise interventions have not been tailored to alleviate CRF in fatigued cancer survivors, and thus the potential to alleviate CRF may not have been realized. The primary aim of this research is to investigate the effect of a traditional vs. tailored 12-week exercise intervention on self-reported CRF severity.
Detailed description
Background and Rationale
Approximately one-third of cancer survivors experience severe and persistent fatigue for a number of years post-treatment, but this distressing symptom is often under-treated by healthcare professionals due to a lack of mechanism-targeted interventions. The assessment of cancer-related fatigue (CRF) is reliant on subjective fatigue measurements such as self-report questionnaires. Less attention has been given to objective physiological measurements. However, there are well-established techniques which allow the assessment of neuromuscular fatigue and its peripheral and central origins which could be utilized in the study of CRF. Very few studies have considered these objective measures alongside self-report scales in the study of CRF and only two have used such techniques in cancer survivors. To date, no studies have investigated neuromuscular fatigue in whole body, dynamic activity as relevant to daily tasks (and involving the lower limb due to its functional relevance to locomotion). Novel testing developed in our laboratory could be used as part of a wider screening to develop individualized interventions to alleviate CRF. It is well accepted in the field that CRF is multidimensional and in addition to a potential neuromuscular component, the role of sleep disturbance may also be implicated. Interventions targeted at improving sleep quality are therefore warranted, and there is sound evidence for the efficacy of exercise interventions in particular for improving CRF in cancer survivors. As a non-pharmacological intervention, physical activity has the strongest evidence base for treating CRF. However, the mechanisms explaining the reduction of CRF with exercise are not understood. Due to the complex and multi-factorial nature of CRF, it would be of benefit to tailor exercise interventions to the specific deficits (in regards to neuromuscular mechanisms) or difficulties (for example sleep disturbance) experienced by the individual. Ultimately, mechanism-targeted exercise interventions could be translated to clinical rehabilitation programs and lead to an improved quality of for cancer survivors.
Research Question \& Objectives
The primary aim of this research is to investigate the effect of a traditional vs. tailored 12-week exercise intervention on self-reported CRF severity.
Methods
Fatigued cancer survivors who have completed primary treatment ≥ 3 months and ≤ 5 years from enrollment will be randomly allocated to one of two treatment arms: traditional (active control) and tailored exercise. Participants in the traditional exercise group will engage in aerobic and resistance exercise that is consistent with published recommendations. The tailored exercise group will be prescribed an intervention designed to address individual deficits (identified at baseline) that may be related to CRF. Participants will be assessed before and after the intervention for patient-reported outcomes, neuromuscular function and fatigue in response to whole-body exercise, sleep quantity and quality, physical activity levels, cardiorespiratory fitness and blood biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Traditional Exercise | Active comparator | Other: Traditional ExerciseA classical exercise intervention based on current guidelines for cancer survivors. |
| Tailored Exercise | Experimental | Other: Tailored ExerciseA tailored and individualized exercise intervention based on the results of pre-intervention testing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 18 and 75 years;
- Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score ≤ 34;
- Completion of treatment in ≥ 3 months and ≤ 5 years preceding enrollment;
- Approval received from personal physician and/or a Canadian Society for Exercise Physiology-Clinical Exercise Physiologist (CSEP-CEP);
- Command of the English language.
Key exclusion criteria (4 listed)
- Contraindication to experimental procedures including transcranial magnetic stimulation (TMS);
- Diagnosed as having obstructive sleep apnea or anemia;
- Currently participating in a structured exercise intervention;
- Participant is pregnant.
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 |
|---|---|---|
| Traditional ExerciseThe traditional exercise group will undertake a supervised exercise intervention involving aerobic exercise and light resistance training, in line with published guidelines for exercise in cancer survivors. | Other | Traditional Exercise |
| Tailored ExerciseThe tailored training group will be prescribed an individualized exercise intervention designed specifically to counteract deficits (e.g. neuromuscular) of difficulties (e.g. sleep disturbance) identified during pre-intervention testing. | Other | Tailored Exercise |
Primary outcome
Assessment of change in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale
Time frame: Baseline to after the 12-week intervention, at 6 month and 12 month follow up.
Self-report questionnaire for the assessment of cancer-related fatigue.
43 secondary outcomes
Assessment of change in The Functional Assessment of Cancer Therapy - General (FACT-G)
Time frame: Baseline and after the 12-week intervention.
Assessment of change in Edmonton Symptom Assessment System-revised tiredness scale
Time frame: Baseline and after the 12-week intervention, and during follow up (6 and 12 months).
Maximal Isometric Force in the Knee Extensors
Time frame: Baseline and after the 12-week intervention.
Cortical Voluntary Activation
Time frame: Baseline and after the 12-week intervention.
Voluntary Activation
Time frame: Baseline and after the 12-week intervention.
Potentiated Doublet Twitch Force
Time frame: Baseline and after the 12-week intervention.
Muscle Compound Action Potential (M-Wave) Peak-to Peak Amplitude
Time frame: Baseline and after the 12-week intervention.
Muscle Compound Action Potential (M-Wave) Peak-to Peak Duration
Time frame: Baseline and after the 12-week intervention.
Muscle Compound Action Potential (M-Wave) Area
Time frame: Baseline and after the 12-week intervention.
Motor Evoked Potential (MEP) Peak-to Peak Amplitude
Time frame: Baseline and after the 12-week intervention.
Motor Evoked Potential (MEP) Peak-to Peak Duration
Time frame: Baseline and after the 12-week intervention.
Motor Evoked Potential (MEP) Area
Time frame: Baseline and after the 12-week intervention.
Cortical Silent Period
Time frame: Baseline and after the 12-week intervention.
Voluntary Electromyography (EMG)
Time frame: Baseline and after the 12-week intervention.
Amplitude of the Sleep-Wake Cycle
Time frame: Baseline and after the 12-week intervention.
Peak Time of the sleep-wake Cycle
Time frame: Baseline and after the 12-week intervention.
Mesor of the Sleep-Wake Cycle
Time frame: Baseline and after the 12-week intervention.
inter-daily stability
Time frame: Baseline and after the 12-week intervention.
intra-daily variability
Time frame: Baseline and after the 12-week intervention.
L5
Time frame: Baseline and after the 12-week intervention.
L5 mid
Time frame: Baseline and after the 12-week intervention.
Wake actigraphy
Time frame: Baseline and after the 12-week intervention.
Sleep Activity
Time frame: Baseline and after the 12-week intervention.
Activity Index
Time frame: Baseline and after the 12-week intervention.
Time in bed
Time frame: Baseline and after the 12-week intervention.
Actual Sleep Time
Time frame: Baseline and after the 12-week intervention.
Actual Wake Time
Time frame: Baseline and after the 12-week intervention.
Sleep Onset Latency
Time frame: Baseline and after the 12-week intervention.
Sleep Efficiency
Time frame: Baseline and after the 12-week intervention.
Fragmentation index
Time frame: Baseline and after the 12-week intervention.
Blood Biomarkers
Time frame: Baseline and after the 12-week intervention.
Assessment of change in the Centre for Epidemiological Studies Depression Scale (CES-D) questionnaire.
Time frame: Baseline and after the 12-week intervention.
Assessment of change in The Social Prevision Scale (SPS)
Time frame: Baseline and after the 12-week intervention.
Assessment of change in The Functional Assessment of Cancer Therapy (FACT) Cancer Specific
Time frame: Baseline and after the 12-week intervention.
Assessment of change in The Modified-Godin Leisure Time Exercise Questionnaire (GLTEQ)
Time frame: Baseline, after the 12-week intervention, and during follow up (6 and 12 months).
Assessment of change in The Insomnia Severity Index (ISI)
Time frame: Baseline and after the 12-week intervention.
Assessment of change in The Brief Pain Inventory Short Form (BPI-sf)
Time frame: Baseline and after the 12-week intervention.
Assessment of change in Maximal Oxygen Uptake
Time frame: Baseline and after the 12-week intervention.
Assessment of change in Muscle Cross-Sectional Area
Time frame: Baseline and after the 12-week intervention.
Heart Rate Variability
Time frame: Baseline and after the 12-week intervention.
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 12 Oct 2021.
- Derived from this study: PubMed 30041626Twomey R, Martin T, Temesi J, Culos-Reed SN, Millet GY. Tailored exercise interventions to reduce fatigue in cancer survivors: study protocol of a randomized controlled trial. BMC Cancer. 2018 Jul 24;18(1):757. doi: 10.1186/s12885-018-4668-z.
- Individual participant dataSharing planned: No
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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.
Guillaume Millet, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Exercise and Tailored Exercise in people with Cancer-related Fatigue, run by University of Calgary at 1 site in Canada.
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 5 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 12 Oct 2021. 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 Canada. 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?
Assessment of change in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale (time frame: Baseline to after the 12-week intervention, at 6 month and 12 month follow up.). 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 NCT03049384, 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 12 Oct 2021.