Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-02424 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
PRIMARY OBJECTIVES:
I. 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:
I. 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavior Therapy | Behavioral | Undergo PROSPECT internet-based CBT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to 12 weeks post intervention (24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to 12 weeks post intervention (24 weeks) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Umang Swami, MD | Huntsman Cancer Institute/ University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | United States |
Not provided
| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Exercise Intervention | Behavioral | Undergo POWER exercise intervention |
|
| 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. |
| Baseline up to 12 weeks post intervention (24 weeks) |
| D009369 |
| Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |