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Trial Title:
PROWESS (PROstate Cancer Wearables Exercise and Structured Supports): A Pilot Supportive Care Intervention
NCT ID:
NCT05755490
Condition:
Prostate Cancer
Prostatic Neoplasms
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate Cancer
Prostatic Neoplasms
Androgen Deprivation Therapy
ADT
CBR
Cognitive Behavioral Therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
PROWESS
Description:
Structured, culturally sensitive behavior change intervention comprised of six
video-based or in-person sessions with psychologist or social worker. FitBit is provided
by study.
Arm group label:
PROWESS
Summary:
The goal of this research study is to conduct an open pilot of a behavioral change
intervention called PROstate Cancer Wearables, Exercise, and Structured Supports
(PROWESS) for integrating health behavior change tools and to increase exercise, reduce
side effects of androgen deprivation therapy (ADT), and improve quality of life in Black
and Hispanic/Latino men with prostate cancer.
The name of the intervention used in this research study is:
PROWESS (behavioral change intervention)
Detailed description:
This research study is to test a behavioral change intervention called PROstate Cancer
Wearables, Exercise, and Structured Supports (PROWESS) for integrating health behavior
change tools with wearable technology, to increase exercise, reduce side effects of
androgen deprivation therapy (ADT), and improve quality of life in Black and
Hispanic/Latino men with prostate cancer on androgen deprivation therapy (ADT).
Study procedures include screening for eligibility, intervention sessions, questionnaires
and surveys, and an exit interview with study staff.
Participation in this research study is expected to last for up to four months.
The goal and primary outcome of this open pilot study is refinement of the intervention
and study procedures to allow for us to conduct a larger feasibility study in the future.
It is expected that about 10 people will take part in this research study.
This research study is being supported by the MGH Cancer Center
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Diagnosed with prostate cancer.
- Has been on androgen deprivation therapy (ADT) for at least three months, and
planned to continue ADT as of last clinic visit.
- Black Race AND/OR Hispanic/Latino Ethnicity (confirmed by patient self-report)
- Verbal fluency in English or Spanish.
- Receiving ongoing oncology care at MGH Cancer Center.
- Age ≥ 18 years.
- Self-Report less than or equal to 150 minutes of moderate or vigorous structured
exercise per week, as assessed by the Exercise is Medicine Physical Activity Vital
Sign Assessment.
- Access to a smartphone or a computer with USB Bluetooth adapter.
Exclusion Criteria:
- Unwilling or unable to participate in the study.
- Significant psychiatric, cognitive or other comorbid disease which the treating
clinician believes prohibits informed consent or participation in the study.
- Currently receiving chemotherapy.
- Prognosis less than 6 months, per the judgment of the primary oncologist.
- Medical contraindication to physical activity, as assessed by outpatient oncologist.
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Massachusetts General Hospital Cancer Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Contact:
Last name:
Daniel Lage, MD
Phone:
617-726-5130
Email:
dlage@partners.org
Start date:
March 2023
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05755490
