Sedentary LifestylePhase 2NCT03421782
Fatigue Interventions in Cancer (Exercise Intervention)
A Phase 2 study testing Cognitive Behavior Therapy and Exercise Intervention in people with Sedentary Lifestyle and Stage III Prostate Cancer AJCC v7, run by University of Utah at 1 site in United States.
Trial summary
This randomized pilot phase II trial studies how well exercise intervention with or without internet-based cognitive behavior therapy works in reducing fatigue in participants with prostate cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sedentary Lifestyle, Stage III Prostate Cancer AJCC v7, Stage IV Prostate Cancer AJCC v7
- What is being tested?
- Cognitive Behavior Therapy and Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2018to 8 Aug 2022
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with advanced prostate cancer
- Currently treated with hormone therapy-based regimen, including selective estrogen receptor modulators (SERMs), aromatase inhibitors, selective estrogen receptor down regulators (SERDs), CYP17A1 inhibitors, gonadotrophin releasing hormone (GnRH) agonists/antagonists, and antiandrogens; concurrent anti-HER2 therapy and other targeted therapy (e.g., CDK4/6 inhibitor, mTOR inhibitor) is permitted; must have started the current regimen at least 4 weeks prior to enrollment
- A response of at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired) to the question ?how tired did you feel in the past week??
- Sedentary activity pattern (Average < 90 minutes per week of moderate-to-vigorous intensity sports activity based on patient self-report) within the past year
- Physically able to exercise and physician consent to start an exercise program
- Regular access to a computer with internet service
- Must be able to read and understand English
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
Who cannot join
- Evidence of disease progression at the time of enrollment
- Treatment with cytotoxic chemotherapy within 3 months prior to enrollment
- Prior cognitive-behavioral therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: Nonpharmacologic Interventions for Fatigue in Patients With Cancer
This randomized pilot phase II trial studies how well exercise intervention with or without internet-based cognitive behavior therapy works in reducing fatigue in participants with prostate cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Exercise intervention and internet-based cognitive behavior therapy may help to improve feelings of tiredness in participants with prostate cancer.
The study originally included both prostate cancer and breast cancer participants, but due to low accrual of breast cancer participants, the breast cancer cohort was closed and the study continued with prostate cancer participants only.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the change in fatigue from baseline to week 12 in all patients with prostate cancer, as assessed with the PROMIS Fatigue questionnaire, with 12 weeks of POWER exercise program.
SECONDARY OBJECTIVES:
- To evaluate the change in fatigue from baseline to week 12 in patients with prostate cancer who completed both baseline and 12 week assessments, as assessed with the PROMIS Fatigue questionnaire, with 12 weeks of the POWER exercise program.
II. To evaluate the change in cardiorespiratory fitness from baseline to Week 12, as assessed with the graded exercise test, with 12 weeks of the POWER exercise program.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo POWER exercise intervention consisting of supervised exercise training sessions over 50 minutes every 7 days for a total of 12 sessions and 150 minutes of moderate-intensity exercise weekly for 12 weeks.
ARM II: Patients undergo POWER exercise intervention consisting of supervised exercise training sessions over 50 minutes every 7 days for a total of 12 sessions and 150 minutes of moderate-intensity exercise weekly for 12 weeks. Patients also undergo PROSPECT internet-based cognitive behavior therapy (CBT) intervention over 12 weeks.
After completion of study, patients are followed up every 6-12 months for 2 years.
Because of challenges with the PROSPECT intervention, including multiple periods of time during which the intervention was not available and loss of data about use of the intervention by participants because of a computer virus, it appears that the majority of patients randomized to that arm of the study did not actually use the intervention. Therefore evaluable participants will be combined and analyzed as a single cohort.
- Being tested
- Cognitive Behavior Therapy, Exercise Intervention
- Medical subject headings
- Sedentary Behavior, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior TherapyBehavioural
Also called CBT, cognitive therapy, CT
Undergo PROSPECT internet-based CBT
Exercise InterventionBehavioural
Undergo POWER exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| Exercise - Arm I | Experimental | Patients undergo POWER exercise intervention consisting of supervised exercise training sessions over 50 minutes every 7 days for a total of 12 sessions and 150 minutes of moderate-intensity exercise weekly for 12 weeks. Receives: Behavioral: Exercise Intervention |
| Exercise plus PROSPECT Cognitive Behavior Therapy (CBT) | Experimental | Patients undergo POWER exercise intervention consisting of supervised exercise training sessions over 50 minutes every 7 days for a total of 12 sessions and 150 minutes of moderate-intensity exercise weekly for 12 weeks. Patients also undergo PROSPECT internet-based CBT intervention over 12 weeks. Receives: Behavioral: Cognitive Behavior Therapy; Behavioral: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatigue
Change in fatigue from baseline to week 12 in all patients with prostate cancer, as assessed with the PROMIS Fatigue questionnaire, with 12 weeks of the POWER exercise program.
Measured: Baseline up to 12 weeks post intervention (24 weeks)
Secondary outcomes (2)
Change in Quality of Life
Change in fatigue from baseline to week 12 in patients with prostate cancer who completed both baseline and 12 week assessments, as assessed with the PROMIS Fatigue questionnaire, with 12 weeks of the POWER exercise program.
Measured: Baseline up to 12 weeks post intervention (24 weeks)
Change in activity level
Evaluate the change in cardiorespiratory fitness from baseline to Week 12, as assessed with the graded exercise test, with 12 weeks of the POWER exercise program.
Measured: Baseline up to 12 weeks post intervention (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start26 Feb 2018
- Primary completion25 Apr 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Umang Swami, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421782
- Sponsor's protocol ID
- HCI105691
- Other IDs
- NCI-2017-02424
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2018
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonpharmacologic Interventions for Fatigue in Patients With Cancer
- ClinicalTrials.gov ID
- NCT03421782
- Acronym / sponsor ID
- HCI105691
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 5 Feb 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.
This randomized pilot phase II trial studies how well exercise intervention with or without internet-based cognitive behavior therapy works in reducing fatigue in participants with prostate cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Exercise intervention and internet-based cognitive behavior therapy may help to improve feelings of tiredness in participants with prostate cancer.
The study originally included both prostate cancer and breast cancer participants, but due to low accrual of breast cancer participants, the breast cancer cohort was closed and the study continued with prostate cancer participants only.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the change in fatigue from baseline to week 12 in all patients with prostate cancer, as assessed with the PROMIS Fatigue questionnaire, with 12 weeks of POWER exercise program.
SECONDARY OBJECTIVES:
- To evaluate the change in fatigue from baseline to week 12 in patients with prostate cancer who completed both baseline and 12 week assessments, as assessed with the PROMIS Fatigue questionnaire, with 12 weeks of the POWER exercise program.
II. To evaluate the change in cardiorespiratory fitness from baseline to Week 12, as assessed with the graded exercise test, with 12 weeks of the POWER exercise program.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo POWER exercise intervention consisting of supervised exercise training sessions over 50 minutes every 7 days for a total of 12 sessions and 150 minutes of moderate-intensity exercise weekly for 12 weeks.
ARM II: Patients undergo POWER exercise intervention consisting of supervised exercise training sessions over 50 minutes every 7 days for a total of 12 sessions and 150 minutes of moderate-intensity exercise weekly for 12 weeks. Patients also undergo PROSPECT internet-based cognitive behavior therapy (CBT) intervention over 12 weeks.
After completion of study, patients are followed up every 6-12 months for 2 years.
Because of challenges with the PROSPECT intervention, including multiple periods of time during which the intervention was not available and loss of data about use of the intervention by participants because of a computer virus, it appears that the majority of patients randomized to that arm of the study did not actually use the intervention. Therefore evaluable participants will be combined and analyzed as a single cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise - Arm I | Experimental | Behavioral: Exercise InterventionPatients undergo POWER exercise intervention consisting of supervised exercise training sessions over 50 minutes every 7 days for a total of 12 sessions and 150 minutes of moderate-intensity exercise weekly for 12 weeks. |
| Exercise plus PROSPECT Cognitive Behavior Therapy (CBT) | Experimental | Behavioral: Cognitive Behavior Therapy, Behavioral: Exercise InterventionPatients undergo POWER exercise intervention consisting of supervised exercise training sessions over 50 minutes every 7 days for a total of 12 sessions and 150 minutes of moderate-intensity exercise weekly for 12 weeks. Patients also undergo PROSPECT internet-based CBT intervention over 12 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with advanced prostate cancer
- Currently treated with hormone therapy-based regimen, including selective estrogen receptor modulators (SERMs), aromatase inhibitors, selective estrogen receptor down regulators (SERDs), CYP17A1 inhibitors, gonadotrophin releasing hormone (GnRH) agonists/antagonists, and antiandrogens; concurrent anti-HER2 therapy and other targeted therapy (e.g., CDK4/6 inhibitor, mTOR inhibitor) is permitted; must have started the current regimen at least 4 weeks prior to enrollment
- A response of at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired) to the question ?how tired did you feel in the past week??
- Sedentary activity pattern (Average < 90 minutes per week of moderate-to-vigorous intensity sports activity based on patient self-report) within the past year
- Physically able to exercise and physician consent to start an exercise program
Key exclusion criteria (3 listed)
- Evidence of disease progression at the time of enrollment
- Treatment with cytotoxic chemotherapy within 3 months prior to enrollment
- Prior cognitive-behavioral therapy
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 |
|---|---|---|
| Cognitive Behavior TherapyAlso: CBT, cognitive therapy, CTUndergo PROSPECT internet-based CBT | Behavioural | Exercise plus PROSPECT Cognitive Behavior Therapy (CBT) |
| Exercise InterventionUndergo POWER exercise intervention | Behavioural | Exercise - Arm I, Exercise plus PROSPECT Cognitive Behavior Therapy (CBT) |
Primary outcome
Change in fatigue
Time frame: Baseline up to 12 weeks post intervention (24 weeks)
Change in fatigue from baseline to week 12 in all patients with prostate cancer, as assessed with the PROMIS Fatigue questionnaire, with 12 weeks of the POWER exercise program.
2 secondary outcomes
Change in Quality of Life
Time frame: Baseline up to 12 weeks post intervention (24 weeks)
Change in activity level
Time frame: Baseline up to 12 weeks post intervention (24 weeks)
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 17 Feb 2026.
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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.
Umang Swami, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive Behavior Therapy and Exercise Intervention in people with Sedentary Lifestyle and Stage III Prostate Cancer AJCC v7, run by University of Utah 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 8 inclusion and 3 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 17 Feb 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in fatigue (time frame: Baseline up to 12 weeks post intervention (24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.