NCT05508412

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 18, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

December 6, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2025

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2.4 years

First QC Date

August 18, 2022

Last Update Submit

March 16, 2026

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Feasibility (accrual, attrition, compliance, and adverse events)

    As measured by accrual, attrition, compliance rates, and safety by number of adverse events.

    6 - 24 months

Secondary Outcomes (18)

  • Mental Health as assessed by the Kessler Kessler Psychological Distress Scale (K10)

    6 - 24 months

  • General Health (Physical and Mental) Quality of Life assessed by the 12-item Short Form Health Survey (SF-12)

    6 - 24 months

  • Health-Related Quality of Life as assessed by the Functional Assessment of Cancer Therapy - General (FACT-G)

    6 - 24 months

  • Personality as assessed by the Ten-Item Personality Inventory (TIPI)

    6 - 24 months

  • Alcohol Habit assessed by questions from the NIH Alcohol Consumption questionnaire.

    6 - 24 months

  • +13 more secondary outcomes

Study Arms (2)

Intervention with HRV monitor

EXPERIMENTAL
Behavioral: CancerPEP

Intervention without HRV monitor

EXPERIMENTAL
Behavioral: CancerPEP

Interventions

CancerPEPBEHAVIORAL

CancerPEP

Intervention with HRV monitorIntervention without HRV monitor

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Related Publications (1)

  • 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.

    PMID: 39409993DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 19, 2022

Study Start

December 6, 2022

Primary Completion

April 13, 2025

Study Completion

April 13, 2025

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

CA(1)