Cancer Patient Empowerment Program: Phase 2 Feasibility Study

NCT ID: NCT05508412

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-06
• Study Completion Date: 2025-03-15

Brief Summary

The Cancer Patient Empowerment Program is a comprehensive health promotion program aiming to improve the quality of life as well as both physical and mental health in cancer patients and survivors. The program includes daily email communications over 6 months that encourage strength and aerobic exercise, yoga, stress reduction techniques, dietary improvements, and more.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention with HRV monitor

Group Type: EXPERIMENTAL

CancerPEP

Intervention Type: BEHAVIORAL

CancerPEP

Intervention without HRV monitor

Group Type: EXPERIMENTAL

CancerPEP

Intervention Type: BEHAVIORAL

CancerPEP

Interventions

CancerPEP

CancerPEP

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age >18.
• History of a cancer diagnosis as per the participant's report.
• Safe to exercise and do strength training. Participants who have recovered from a minor stroke or heart condition in the past will require approval from their Family Physician or Cardiologist to participate in the study.
• Participants with advanced cancer (including cancer spread to bones) will need approval from the Study Physician or their Oncologist to participate.
• Existing (or willingness to create) email account and willingness to access email daily.
• Ability to follow website links to watch YouTube videos.
• Ability to understand and speak English.
• Ability to participate in low to moderate levels of physical activity and strength training.
• Ability and willingness to fill out an online survey at baseline, and 6, 12 and possibly 24 months, and a weekly compliance survey for the six months of the program.
• Deemed to have an expected survival greater than 1 year and expected to be well enough to complete the six-month training

Exclusion Criteria

• Patients deemed unfit to participate in low to moderate level exercise e.g., including but not limited to a myocardial infarction or stroke within the last year, without approval from their Family Physician or Cardiologist that they are safe to exercise.
• Unable to access the internet and lack of a computer or smartphone to receive emails required for study intervention, or unable to click on a link to successfully watch a YouTube video.
• Those with a predicted survival less than 1 year, or not expected to be able to participate in the program for six months.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dalhousie University

OTHER

Sponsor Role: collaborator

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Gabriela Ilie

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Countries

Canada

References

Ilie G, Knapp G, Davidson A, Snow S, Dahn HM, MacDonald C, Tsirigotis M, Rutledge RDH. The Cancer Patient Empowerment Program: A Comprehensive Approach to Reducing Psychological Distress in Cancer Survivors, with Insights from a Mixed-Model Analysis, Including Implications for Breast Cancer Patients. Cancers (Basel). 2024 Oct 2;16(19):3373. doi: 10.3390/cancers16193373.

Reference Type: DERIVED

PMID: 39409993 (View on PubMed)

Other Identifiers

CancerPEP-Phase2-Protocol

Identifier Type: -

Identifier Source: org_study_id