PC 360 Survivorship

NCT03017456 | Completed

• 1 other identifier: 15-5045-CE
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 3

Brief Summary

Prostate Cancer Survivorship 360º is a collaboration-based initiative involving prostate cancer (PC) and survivorship researchers/clinicians from three Canadian prostate centers with the goal of identifying and tracking unmet supportive care needs of patients with localized PC and responding to these needs through survivorship care. The current randomized control trail (RCT) will focus on the development and evaluation of a facilitated electronic Prostate Cancer Survivorship Care Plan (PC-SCP). The aims of this project are: 1) to develop an appropriate and tailored SCP and transition care delivery process; and 2) to conduct an RCT to evaluate whether a personalized PC SCP intervention is more effective than usual care (UC) on patient activation (primary outcome) and access to services, self-Management support, satisfaction with information, HRQoL and cancer worry (secondary outcomes). Data from a multi-site prospective database- Prostate Cancer Survivorship Information System (PC360-IS) will be used to electronically populate the survivorship care plans. Overall, this proposal represents initial steps in uniting the country in sharing programmatic resources, data, expertise, and enthusiasm to transform survivorship care for men with PC and their families.

Conditions

Prostate Cancer

Keywords

Survivorship; Prostate Cancer; Survivorship Care Plan

Outcome Measures

Primary Outcomes (1)

• Changes in the Patient Activation measure questionnaire

  Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.

Secondary Outcomes (5)

• Changes in the Health and Social Services Utilization Inventory

  change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.

• Changes in the Health Education Impact Questionnaire

  Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.

• Changes in the Quality of Life INFO25 module

  Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.

• Changes in the Expanded Prostate Cancer Index Composite

  Change from baseline (prior to intervention), 6 months post intervention, 12 months post intervention.

• Changes in the Assessment of Survivors Concerns measure

  baseline (prior to intervention), 6 months post intervention, 12 months post intervention.

Study Arms (2)

Usual Care (UC)

NO INTERVENTION

Patients in the UC arm will not receive the study intervention (behavioral) and instead will receive care according to usual practice. This usually involves a brief office visit (approximately 5-10 minutes) with pertinent history and physical examination related to surgical/radiation recovery, review of the pathology and general instructions regarding the next step in follow-up.

SCP-Intervention vs usual care

ACTIVE COMPARATOR

behavioral intervention vs control Patients in the SCP-Int arm will be asked to attend a one-time appointment with a trained oncology nurse. The SCP-Int is comprised of a 30-minute nurse-led face-to-face intervention and the provision of a tailored PC-specific SCP (PC-SCP). Persistent effects and concerns that are identified will prompt the development of a tailored management plan captured within the PC-SCP. Relevant patient education materials will be linked electronically. Nurses will use motivational interviewing techniques to effective in increase healthy behaviors and empower the PC survivor to actively self-manage persistent treatment effects and to decrease their risk of late effects by providing effective health information, support, and self-management support.

Behavioral: Survivorship Care Plan

Interventions

Survivorship Care Plan BEHAVIORAL

SCP-Intervention: Patients in the SCP-Int arm will attend a one-time appointment with a trained oncology nurse while the patients in the UC arm will receive care according to the hospital standards for follow-up care. The intervention will be delivered during a regular follow-up appointment, face-to-face and will inform and educate patients on self-management and support as well as promote access to and coordination of post-treatment care. The appointment will focus on empowering the PC survivor to actively self-manage persistent treatment effects and to decrease their risk of late effects by providing effective health information, support, and self-management support. Nurses will integrate a number of "active behavior change ingredients" including the integration of motivational interviewing techniques which are effective in increasing healthy behaviors.

Also known as: PC 360-SCP

SCP-Intervention vs usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed localized (T1-T3N0M0) PC
• age at diagnosis \>18 years
• treated with curative intent
• treatment received \>1 month and \<6 months
• disease-free as defined by absence of somatic disease activity parameters as per oncologist/urologist
• consented to participate in the PC360-IS database.

You may not qualify if:

• Patients who do not receive treatment and are followed by active surveillance
• inability to complete study questionnaires.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Vancouver Prostate Centre: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (3)

Vancouver Prostate Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, M5G2C4, Canada

Location

McGill University Health Centre

Montreal, Quebec, H3H 2R9, Canada

Location

Related Publications (1)

• Jones JM, Matthew A, Tanguay S, Higano CS, Goldenberg L, Howell D, Maganti M. A Tailored Electronic Survivorship Care Plan for Prostate Cancer Survivors: A Multicenter Randomized Controlled Trial. J Urol. 2025 Apr;213(4):407-416. doi: 10.1097/JU.0000000000004359. Epub 2024 Dec 20.

  PMID: 39705576 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jennifer M Jones, PhD

  Princess Margaret Cancer Centre, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 11, 2017
• Study Start: May 29, 2017
• Primary Completion: December 30, 2019
• Study Completion: January 31, 2020
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)