Back to resultsPROWESS (PROstate Cancer Wearables Exercise and Structured Supports): A Pilot Supportive Care Intervention
Primary Purpose
Prostate Cancer, Prostatic Neoplasms
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PROWESS
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer focused on measuring Prostate Cancer, Prostatic Neoplasms, Androgen Deprivation Therapy, ADT, CBR, Cognitive Behavioral Therapy
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.
Sites / Locations
- Massachusetts General Hospital Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PROWESS
Arm Description
Participants will complete study procedures as outlined: Wear FitBit watch during the 12-week study period. Group intervention sessions, in-person or virtually. Two, optional follow-up sessions. One-on-one, semi-structured interview with trained study staff to assess participant experience with intervention.
Outcomes
Primary Outcome Measures
Participant Satisfaction
Assessed by the Client Satisfaction Questionnaire-3 (CSQ), a 3-item survey with answers ranging from 1-4, "quite dissatisfied" to "very satisfied."
Secondary Outcome Measures
Change in Objective Physical Activity
Collected physical activity via FitBit measure of steps and activity classification.
Change in Self-Reported Exercise
Assessed by the International Physical Activity Questionnaire (IPAQ), a 27-item self-reported measure of physical activity.
Change in Participant Quality of Life
Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P), which consists of five subscales assessing physical, functional, emotional, social wellbeing.
Change in Participant Distress
Assessed by the Hospital Anxiety and Depression scale (HADS), a 14-item measure with two separate subscales to evaluate symptoms of anxiety and depression.
Full Information
NCT ID
NCT05755490
First Posted
February 13, 2023
Last Updated
February 22, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05755490
Brief Title
PROWESS (PROstate Cancer Wearables Exercise and Structured Supports): A Pilot Supportive Care Intervention
Official Title
PROWESS (PROstate Cancer Wearables Exercise and Structured Supports): A Pilot Supportive Care Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostatic Neoplasms
Keywords
Prostate Cancer, Prostatic Neoplasms, Androgen Deprivation Therapy, ADT, CBR, Cognitive Behavioral Therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PROWESS
Arm Type
Experimental
Arm Description
Participants will complete study procedures as outlined:
Wear FitBit watch during the 12-week study period.
Group intervention sessions, in-person or virtually.
Two, optional follow-up sessions.
One-on-one, semi-structured interview with trained study staff to assess participant experience with intervention.
Intervention Type
Behavioral
Intervention Name(s)
PROWESS
Intervention 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.
Primary Outcome Measure Information:
Title
Participant Satisfaction
Description
Assessed by the Client Satisfaction Questionnaire-3 (CSQ), a 3-item survey with answers ranging from 1-4, "quite dissatisfied" to "very satisfied."
Time Frame
At week 12-14 (intervention completion)
Secondary Outcome Measure Information:
Title
Change in Objective Physical Activity
Description
Collected physical activity via FitBit measure of steps and activity classification.
Time Frame
At Baseline and from weeks 6 - 14
Title
Change in Self-Reported Exercise
Description
Assessed by the International Physical Activity Questionnaire (IPAQ), a 27-item self-reported measure of physical activity.
Time Frame
At Baseline and weeks 12-14
Title
Change in Participant Quality of Life
Description
Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P), which consists of five subscales assessing physical, functional, emotional, social wellbeing.
Time Frame
At Baseline and weeks 12-14
Title
Change in Participant Distress
Description
Assessed by the Hospital Anxiety and Depression scale (HADS), a 14-item measure with two separate subscales to evaluate symptoms of anxiety and depression.
Time Frame
At Baseline and weeks 12-14
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Lage, MD
Phone
617-726-5130
Email
dlage@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Lage, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Lage, MD
Phone
617-726-5130
Email
dlage@partners.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation
Learn more about this trial
PROWESS (PROstate Cancer Wearables Exercise and Structured Supports): A Pilot Supportive Care Intervention
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