Prostate Cancer - Patient Empowerment Program

NCT ID: NCT03660085

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-18
• Study Completion Date: 2022-05-18

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.

Detailed Description

In a survey study of almost 400 survivors of prostate cancer (PC), we found that 17% of them suffered currently from mental health issues, and most were not on medication to address this issue. Compounding issues included urinary and sexual disfunction, poor attendance to support groups, intimacy, problems sleeping and other health problems. To address these many issues directly, with the endorsement of physicians and patients attending our regional PC integrative care conference (April 2018) and expanding on pre-habitation (pre-surgery) science, we created a Patient Empowerment Program (PEP) to be delivered from day one of diagnosis, to educate and teach the men and partners life skills/habits which are aimed to improve their fitness levels and quality of life, and to decrease treatment related side effects. This program is in line with the Auditor General of Nova Scotia's 2017 report endorsing the use of bottom-up evidence-based interventions, created from actively engaging patients in development and process. We aim to trial PC-PEP for men undergoing curative treatment for PC versus a control group receiving standard care. The PC-PEP program includes in-person and multimedia informational, physical activity, pelvic floor, stress reduction, and relationship/connection training. The men are connected with other participants to increase social support and maximize compliance. We use technology to deliver daily alerts to patients to remind them to engage in the program. A PC-PEP feasibility study of 30 men, over 28 days, showed that the program is feasible, leads to positive outcomes in patients and is highly (9.79/10) endorsed by patients. We propose a Randomized Clinical Trial assessing PC-PEP over 6 months from day one of diagnosis. We predict that PC-PEP will improve mental health (primary outcome) and other quality of life outcomes of patients compared with 'usual care'.

This is a randomized, wait-list controlled clinical trial for men newly diagnosed with PC and undergoing curative surgery and/or radiotherapy. The PEP group will receive the intervention for six months (early intervention) while the wait-list group will start the same program at the end of this intervention (late intervention; for six months). Outcomes will be assessed at baseline, six and twelve months. The primary outcome is mental health measured by the Kessler Psychological Distress Scale (K10 questionnaire) at the end of the intervention period. Multiple secondary endpoints include urinary, bowel and sexual function, fitness levels, fatigue, sleep, intimacy/sexuality concerns, relationship satisfaction, social support and surrogates of medical costs (e.g., number of visits to medical professionals).

Introducing a comprehensive empowerment program from day 1 of diagnosis may mitigate against the high levels of mental distress short and long-term suffered by hundreds of Nova Scotian men undergoing curative PC treatment every year, and the burden treatment related side effects will place on our health care system. Given that the study has the endorsement of patients, clinicians and administrators at NSHA, if proven successful it will have the evidence base needed to change the current standard of care.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Arm A - Early Intervention

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.

Group Type: EXPERIMENTAL

PC-PEP

Intervention Type: 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 B - Late Intervention

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.

Group Type: ACTIVE_COMPARATOR

PC-PEP

Intervention Type: 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.

Interventions

PC-PEP

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dalhousie University

OTHER

Sponsor Role: collaborator

Queen Elizabeth II Health Sciences Centre

OTHER

Sponsor Role: collaborator

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Gabriela Ilie

Faculty/Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gabriela Ilie, PhD

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority

Rob Rutledge, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority

Locations

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 39451783 (View on PubMed)

Other Identifiers

PCaPRO_Halifax_002

Identifier Type: OTHER

Identifier Source: secondary_id

PCaPRO_Halifax_001

Identifier Type: -

Identifier Source: org_study_id