Prostate Cancer - Patient Empowerment Program

NCT03660085 | Completed

• 2 other identifiers: PCaPRO_Halifax_001PCaPRO_Halifax_002
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Each year over 20,000 men are diagnosed with prostate cancer in Canada with the majority undergoing some form of treatment option. Radical prostatectomy and/or radiation therapy are common procedures that are effective in the treatment of prostate cancer. However, they typically incur both short- and long-term side effects (e.g. urinary incontinence, sexual dysfunction, reduced physical function, etc) that can negatively impact one's quality of life. This study aims to educate and teach pre- (as opposed to most common post-) habilitation - preventive life habits aimed to empower men and address many of the issues faced by men undergoing radical prostatectomy or other active forms of prostate cancer treatments. The investigators hypothesize that daily text and email reminders, in addition to connecting men with other men undergoing similar challenges, will improve participant adherence to the pre-habilitation program. Secondary objectives will assess change in mental health, physical fitness, urological symptoms, state of relaxation, and quality of life parameters before and after the program.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Radical Prostatectomy; Urological Symptoms; Radiation Therapy; Mental Health; Pre-Habilitation; Exercise; Pelvic floor exercises; Intimacy and Connection; Social connection; Meditation; Stress reduction

Outcome Measures

Primary Outcomes (1)

• Mental Health

  Kessler 10 - assessment of psychological distress pre (day 0) and post (6 months) intervention and end of study (12 months). Measured through on-line survey.

  12 months

Secondary Outcomes (16)

• General Health (Physical and Mental) Quality of Life

  12 months

• Functional, emotional and social well being

  12 month

• Urinary, bowel, hormonal, & sexual function

  12 month

• EEG (Brainwaves)

  12 month

• Heart rate variability

  12 months

Study Arms (2)

Arm A - Early Intervention

EXPERIMENTAL

For 180 days participants in this arm will be exposed to the intervention and 180 days afterwards they will be exposed to the standard of care.

Behavioral: PC-PEP

Arm B - Late Intervention

ACTIVE COMPARATOR

For 180 days participants in this arm will be exposed to the standard of care and 180 days afterwards they will be exposed to the intervention.

Behavioral: PC-PEP

Interventions

PC-PEP BEHAVIORAL

The 6 months "at home" program focuses on aerobic and strength training, pelvic floor muscle exercises, meditation, social connection, and overall healthy lifestyle practices supported with daily text message/email reminders. The aerobic (5 times/week) and strength (2 times/week) program will comprise of a single 30-minute session daily and will be individualized to each participant. Pelvic floor muscle training will include three, 10-minute sessions and mediation for 10 minutes daily. Intimacy and Connection component of PC-PEP consists of engaging in at least one form of intimacy practice prescribed, per day. Social connection will be fostered by pairing participants up with peers from the study. To encourage program compliance, study participants will receive 3 daily reminders to do their pelvic floor muscle exercises per day plus an additional motivational email daily containing helpful tips.

Arm A - Early Intervention; Arm B - Late Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of prostate cancer diagnosis
• Non-metastatic stage at start of study
• Approval from screening physician to participant in study
• Existing (or willingness to create) email account
• Ability to access and use daily email +/- text messages
• Ability to understand and speak English language
• Ability to participate in low to moderate levels of physical activity
• Scheduled for a Radical Prostatectomy (RP) or curative intent Radiotherapy (RT)(external bean or bratty) or adjuvant or salvage RT post RP. Patient on Hormone therapy are eligible if they are scheduled to undergo RP or RT.
• If deemed necessary by study physician, approval from family physician or oncologist to participate in the study

You may not qualify if:

• Unable to travel to Halifax for study visits (3 in total)
• Unable to access the internet and lack of a computer/cellphone to receive emails required for study intervention
• Patients being treated with Hormone therapy only
• Patients on Active Surveillance
• Patients deemed unfit to participate in low level exercise

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Dalhousie University: collaborator
• Queen Elizabeth II Health Sciences Centre: collaborator

Study Sites (1)

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

Related Publications (1)

• Burgher C, Ilie G, Mason R, Rendon R, Kokorovic A, Bailly G, Patil N, Bowes D, Wilke D, MacDonald C, Tsirigotis M, Butler C, Bell D, Spooner J, Rutledge RDH. Assessing the Impact of the Prostate Cancer Patient Empowerment Program (PC-PEP) on Relationship Satisfaction, Quality of Life, and Support Group Participation: A Randomized Clinical Trial. Curr Oncol. 2024 Oct 21;31(10):6445-6474. doi: 10.3390/curroncol31100479.

  PMID: 39451783 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Psychological Well-Being; Motor Activity

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Personal Satisfaction; Behavior

Study Officials

• Gabriela Ilie, PhD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

• Rob Rutledge, MD, FRCPC

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty/Assistant Professor

Model Details: Participants receive one of two (or more) alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 6, 2018
• Study Start: December 18, 2019
• Primary Completion: April 15, 2022
• Study Completion: May 18, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)