Prostate CancerNCT05755490
PROWESS (PROstate Cancer Wearables Exercise and Structured Supports): A Pilot Supportive Care Intervention
A study testing PROWESS in people with Prostate Cancer and Prostatic Neoplasms, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostatic Neoplasms
- What is being tested?
- PROWESS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2023to 29 Sep 2025
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with prostate cancer.
- Planning to be on androgen deprivation therapy (ADT) for at least three months
- 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
- Completion of baseline assessment
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215
About this study
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)
Read the 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
- Conditions
- Prostate Cancer, Prostatic Neoplasms
- Being tested
- PROWESS
- Keywords
- Prostate Cancer, Prostatic Neoplasms, Androgen Deprivation Therapy, ADT, CBR, Cognitive Behavioral Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROWESSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PROWESS | Experimental | Participants will complete study procedures as outlined:
* Wear FitBit watch during the 12-week study period.
* Group intervention sessions, in-person or virtually.
* One optional follow-up session.
* One-on-one, semi-structured interview with trained study staff to assess participant experience with intervention. Receives: Behavioral: PROWESS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: At week 8-12 (intervention completion)
Secondary outcomes (5)
Change in Objective Physical Activity
Collected physical activity via FitBit measure of steps and activity classification.
Measured: At Baseline and from weeks 1 - 12
Change in Self-Reported Exercise
Assessed by the Short-Form International Physical Activity Questionnaire (IPAQ), a self-reported measure of physical activity.
Measured: At Baseline and weeks 8-12
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.
Measured: At Baseline and weeks 8-12
Change in Psychological Distress Symptoms
Assessed by the Patient Health Questinnaire-4, a 4-item measure with two separate subscales to evaluate symptoms of anxiety and depression.
Measured: At Baseline and weeks 8-12
Change in Self-Efficacy for Managing Symptoms
Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions - Managing Symptoms Scale, an 8-item measure to evaluate self-efficacy.
Measured: At Baseline and weeks 8-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start28 Aug 2023
- Primary completion2 Dec 2024
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel E Lage, MD, MSc, Massachusetts General Hospital
- Investigators
- Daniel Lage, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755490
- Sponsor's protocol ID
- 22-609
- Status last verified
- Sep 2025
- First submitted
- 13 Feb 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROWESS (PROstate Cancer Wearables Exercise and Structured Supports): A Pilot Supportive Care Intervention
- ClinicalTrials.gov ID
- NCT05755490
- Acronym / sponsor ID
- 22-609
- Conditions
- Prostate Cancer, Prostatic Neoplasms
- Keywords
- Prostate Cancer, Prostatic Neoplasms, Androgen Deprivation Therapy, ADT, CBR, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 6 Mar 2023 (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.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PROWESS | Experimental | Behavioral: PROWESSParticipants will complete study procedures as outlined: * Wear FitBit watch during the 12-week study period. * Group intervention sessions, in-person or virtually. * One optional follow-up session. * One-on-one, semi-structured interview with trained study staff to assess participant experience with intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with prostate cancer.
- Planning to be on androgen deprivation therapy (ADT) for at least three months
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| PROWESSStructured, culturally sensitive behavior change intervention comprised of six video-based or in-person sessions with psychologist or social worker. FitBit is provided by study. | Behavioural | PROWESS |
Primary outcome
Participant Satisfaction
Time frame: At week 8-12 (intervention completion)
Assessed by the Client Satisfaction Questionnaire-3 (CSQ), a 3-item survey with answers ranging from 1-4, "quite dissatisfied" to "very satisfied."
5 secondary outcomes
Change in Objective Physical Activity
Time frame: At Baseline and from weeks 1 - 12
Change in Self-Reported Exercise
Time frame: At Baseline and weeks 8-12
Change in Participant Quality of Life
Time frame: At Baseline and weeks 8-12
Change in Psychological Distress Symptoms
Time frame: At Baseline and weeks 8-12
Change in Self-Efficacy for Managing Symptoms
Time frame: At Baseline and weeks 8-12
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 2 Oct 2025.
- Individual participant dataSharing planned: Yes. 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.
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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.
Daniel Lage, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROWESS in people with Prostate Cancer and Prostatic Neoplasms, run by Massachusetts General Hospital 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 5 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 2 Oct 2025. 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.
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?
Participant Satisfaction (time frame: At week 8-12 (intervention completion)). 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 2 Oct 2025.