NCT07032584

Brief Summary

People with prostate cancer may have a decreased quality of life due to the cancer itself and due to a lifesaving cancer treatment. Physical therapy, including regular exercise, helps patients with cancer to reduce disease symptoms and improve their quality of life. However, cancer rehabilitation programs in rural areas are not readily available and may require constant travel and significant financial resources, which may limit access to these services on a continuous basis. Technology can allow patients residing in rural areas to exercise at home under the supervision of their rehabilitation team. However, it is unclear how effective this approach is. This research team will conduct a clinical trial in which half of the randomly chosen participants receiving hormonal prostate cancer therapy will use this new technology to exercise at home. Another half - will exercise at home without this new technology. After six months, the study will compare the quality of life and cancer symptoms in these two groups. The investigators hope that this study will demonstrate that the patients who were helped by the new technology to exercise at home will have better fitness, fewer symptoms, and better quality of life. If the study demonstrates this in this project, other patients with cancer residing in rural areas will be able to take advantage of this technology. This approach can be extended to people with different diseases who have difficulties accessing medical care in rural areas to undergo required physical, cognitive, and occupational rehabilitation, and improve their quality of life.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
43mo left

Started May 2025

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
May 2025Dec 2029

Study Start

First participant enrolled

May 27, 2025

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

4.5 years

First QC Date

June 15, 2025

Last Update Submit

July 29, 2025

Conditions

Prostate CancerMetastatic Prostate CancerAndrogen Deprivation Therapy

Keywords

TelerehabilitationRural Health

Outcome Measures

Primary Outcomes (1)

  • Functional Assessment of Cancer Therapy-Prostate (FACT-P)

    To assess disease-specific quality of life (QOL) in prostate cancer patients. FACT-P is a 5-point Likert scale from "0 Not at all" to "4 Very much". The FACT-P is a 39-item questionnaire with a minimum score of 0 and a maximum score of 156. Lower scores indicate worse QOL, and higher scores indicate better QOL. This outcome measure will report mean FACT-P total score.

    up to 6 months from baseline

Secondary Outcomes (6)

  • 30-second Sit-to-Stand Test

    up to 6 months from baseline

  • Godin Leisure Score Index

    up to 6 months from baseline

  • 8-foot Timed Up and Go

    up to 6 months from baseline

  • FACIT-Fatigue

    up to 6 months from baseline

  • Exercise Self-Efficacy Scale (EXSE)

    up to 6 months from baseline

  • +1 more secondary outcomes

Study Arms (2)

Telerehabilitation Intervention

EXPERIMENTAL

Participants in the Telerehabilitation Intervention group (TR) will receive a comprehensive baseline examination conducted by the blinded assessment team. They will also be evaluated by the clinical PT who will prescribe an individualized exercise plan and train them how to perform the exercises. Patients will be mailed exercise equipment (portable bike, elastic bands, pulse oximeter, and activity tracker) with the necessary instructions. Additionally, the TR group will also receive a touchscreen tablet for computer-mediated support in following their individualized exercise plans at their homes daily. The tablet will contain multimedia instructional materials on how to set up and use the telerehab unit.

Other: Telerehabilitation Intervention

Best Available Care

OTHER

Participants in the Best Available Care (BAC) group will receive a comprehensive baseline examination conducted by the blinded assessment team. They will also be evaluated by the clinical PT who will prescribe an individualized exercise plan and train them how to perform the exercises. Patients will be mailed exercise equipment (portable bike, elastic bands, pulse oximeter, and activity tracker) with the necessary instructions.

Other: Telerehabilitation Intervention

Interventions

Telerehabilitation InterventionOTHER

TheTelerehabilitation Intervention (TR) group utilizes a touchscreen tablet equipped with a computer-guided rehabilitation program that provides ongoing support and feedback for home-based rehabilitation.

Best Available CareTelerehabilitation Intervention

Eligibility Criteria

Age21 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 21 years or older
  • Confirmed diagnosis of prostate cancer
  • Men receiving standard-of-care ADT either for high-risk, locally advanced prostate cancer or as a part of multicomponent management of metastatic prostate cancer;
  • Residing in a rural community defined by the Rural-Urban Commuting Area (RUCA) codes from the Federal Office of Rural Health Policy (4 and higher).

You may not qualify if:

  • Have unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers, painful or unstable bony metastases, or recent skeletal fractures.
  • Are engaged in a regular exercise rehabilitation program.
  • Have relocation plans within the next 6 months
  • Participate in another clinical trial related to prostate cancer or rehabilitation. The patients will also be required to have a working telephone line in their home or a cell phone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

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MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Manish Kohli, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manish Kohli, MD

CONTACT

801-646-4018Manish.Kohli@hci.utah.edu

Aileen Gabriel

CONTACT

9782109782aileen.gabriel@utah.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2025

First Posted

June 24, 2025

Study Start

May 27, 2025

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)