Cancer Patient Empowerment Program: Phase 2 Feasibility Study (CancerPEP)

March 16, 2026 updated by: Gabriela Ilie, Nova Scotia Health Authority

CancerPEP Phase 2 Randomized Trial: Feasibility of a Comprehensive Cancer Patient Empowerment Program Providing Immediate Versus Delayed Stress Reduction Biofeedback Equipment

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QEII Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention with HRV monitor
Behavioral: CancerPEP
CancerPEP
Experimental: Intervention without HRV monitor
Behavioral: CancerPEP
CancerPEP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility (accrual, attrition, compliance, and adverse events)
Time Frame: 6 - 24 months
As measured by accrual, attrition, compliance rates, and safety by number of adverse events.
6 - 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mental Health as assessed by the Kessler Kessler Psychological Distress Scale (K10)
Time Frame: 6 - 24 months
A 10 item questionnaire that assesses psychological distress. The scale has a score range of 10-50, with higher scores indicating worse mental health.
6 - 24 months
General Health (Physical and Mental) Quality of Life assessed by the 12-item Short Form Health Survey (SF-12)
Time Frame: 6 - 24 months
A 12 item questionnaire. The scale has a score range of 0-100, with higher scores indicating better physical and mental health functioning.
6 - 24 months
Health-Related Quality of Life as assessed by the Functional Assessment of Cancer Therapy - General (FACT-G)
Time Frame: 6 - 24 months
A 27 item questionnaire that measures the four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. The scale has a score range of 0-108, with higher scores indicating better quality of life.
6 - 24 months
Personality as assessed by the Ten-Item Personality Inventory (TIPI)
Time Frame: 6 - 24 months
A 10 item questionnaire assessing the Big-Five personality dimensions (Extraversion, Agreeableness, Conscientiousness, Emotional Stability, Openness to Experiences). The scale has a score range of 1-14 for each dimension with higher scores indicating a higher level of that personality trait.
6 - 24 months
Alcohol Habit assessed by questions from the NIH Alcohol Consumption questionnaire.
Time Frame: 6 - 24 months
Questions assessing alcohol consumption
6 - 24 months
Smoking habit assessed by the Global Adult Tobacco Survey 2020 (GATS).
Time Frame: 6 - 24 months
Questions assessing smoking use
6 - 24 months
Diet assessed by the Rapid Eating Assessment for Participants (REAP-S).
Time Frame: 6 - 24 months
A 16 item questionnaire assessing diet quality. The scale has a score range of 13-39 with a higher score indicating a higher diet quality.
6 - 24 months
Comorbidity level assessed by the modified Charlson Comorbidity Index (CCI)
Time Frame: 6 - 24 months
Each category is scored from 1-6. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use.
6 - 24 months
Availability of social support assessed by the MOS Social Support Survey
Time Frame: 6 - 24 months
A 19 item questionnaire that assesses emotional/informational support, positive social interaction, tangible support and affectionate support. Higher item scores reflect a higher level of social support.
6 - 24 months
Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 6 - 24 months
A 19 item questionnaire that assesses sleep quality and disturbances. The scale has a score range of 0-21 with a higher score indicating worse sleep quality.
6 - 24 months
Sedentary behaviour measured by the Sedentary Behaviour Questionnaire (SBQ) for Adults.
Time Frame: 6 - 24 months
Two 9 item questionnaires (weekday and weekend) with each item scored to none to 6 hours or more. The total score is the sum of the amount of time and as it increases it indicates higher amount of sedentary behaviour.
6 - 24 months
Sexual functioning in women assessed by the 6-item Female Sexual Function Index (FSFI-6).
Time Frame: 6 - 24 months
A 6-item shortened version of the original index. Items are rated on a 5-point Likert scale, ranging from 1 to 5, and the other items are rated on a 6-point Likert scale, ranging from 0 to 5. Total scores range from 2 to 30, with lower scores indicating worse sexual functioning.
6 - 24 months
Sexual functioning in men assessed by the Sexual Health Inventory in Men (SHIM).
Time Frame: 6 - 24 months
A 5-item questionnaire with scores ranging from 1-25 and lower scores indicating worse sexual functioning.
6 - 24 months
Anxiety severity assessed by the GAD-7.
Time Frame: 6 - 24 months
A 7 item questionnaire with scores ranging from 0-21 higher scores indicating more severe level of anxiety.
6 - 24 months
Relationship satisfaction as assessed by the Dyadic Adjustment Scale (DAS-32).
Time Frame: 6 - 24 months
A 32 item questionnaire that measure an individual's perceptions of their relationship with an intimate partner. The scale has a total score range of 1-151 with a higher score indicating better satisfaction.
6 - 24 months
Center for Epidemiologic Studies Depression Scale (CES-D).
Time Frame: 6 - 24 months
A 20 item questionnaire with a possible range of scores from zero to 60, with the higher scores indicating the presence of more depressive symptomatology.
6 - 24 months
Satisfaction with Life Scale (SWLS).
Time Frame: 6 - 24 months
A 5 item questionnaire that was designed to measure subjective well-being. Scores range from 5-35 with higher scores indicating higher satisfaction with life.
6 - 24 months
Brief Illness Perception Questionnaire (IPQ).
Time Frame: 6 - 24 months
A 9 item sale that measures an individual's beliefs, feelings, and cognitive representations of one's illness.
6 - 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nova Scotia Health Authority

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dalhousie University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 6, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 13, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CancerPEP-Phase2-Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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