Clinical trial NCT05755490: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Prostatic Neoplasms
Keywords: Prostate Cancer
Prostatic Neoplasms
Androgen Deprivation Therapy
ADT
CBR
Cognitive Behavioral Therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: Inclusion Criteria:

* 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

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.

Primary outcomes:
measure: Participant Satisfaction
timeFrame: At week 8-12 (intervention completion)
Secondary outcomes:
measure: Change in Objective Physical Activity
timeFrame: At Baseline and from weeks 1 - 12
measure: Change in Self-Reported Exercise
timeFrame: At Baseline and weeks 8-12
measure: Change in Participant Quality of Life
timeFrame: At Baseline and weeks 8-12
measure: Change in Psychological Distress Symptoms
timeFrame: At Baseline and weeks 8-12
measure: Change in Self-Efficacy for Managing Symptoms
timeFrame: At Baseline and weeks 8-12
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Daniel Lage, MD
role: PRINCIPAL_INVESTIGATOR
References: