Clinical trial NCT05508412: Cancer Patient Empowerment Program: Phase 2 Feasibility Study
Official title: CancerPEP Phase 2 Randomized Trial: Feasibility of a Comprehensive Cancer Patient Empowerment Program Providing Immediate Versus Delayed Stress Reduction Biofeedback Equipment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Dalhousie University
First posted: 2022-08-19
Enrollment: 104
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Feasibility (accrual, attrition, compliance, and adverse events)
timeFrame: 6 - 24 months
Secondary outcomes:
measure: Mental Health as assessed by the Kessler Kessler Psychological Distress Scale (K10)
timeFrame: 6 - 24 months
measure: General Health (Physical and Mental) Quality of Life assessed by the 12-item Short Form Health Survey (SF-12)
timeFrame: 6 - 24 months
measure: Health-Related Quality of Life as assessed by the Functional Assessment of Cancer Therapy - General (FACT-G)
timeFrame: 6 - 24 months
measure: Personality as assessed by the Ten-Item Personality Inventory (TIPI)
timeFrame: 6 - 24 months
measure: Alcohol Habit assessed by questions from the NIH Alcohol Consumption questionnaire.
timeFrame: 6 - 24 months
measure: Smoking habit assessed by the Global Adult Tobacco Survey 2020 (GATS).
timeFrame: 6 - 24 months
measure: Diet assessed by the Rapid Eating Assessment for Participants (REAP-S).
timeFrame: 6 - 24 months
measure: Comorbidity level assessed by the modified Charlson Comorbidity Index (CCI)
timeFrame: 6 - 24 months
measure: Availability of social support assessed by the MOS Social Support Survey
timeFrame: 6 - 24 months
measure: Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 6 - 24 months
measure: Sedentary behaviour measured by the Sedentary Behaviour Questionnaire (SBQ) for Adults.
timeFrame: 6 - 24 months
measure: Sexual functioning in women assessed by the 6-item Female Sexual Function Index (FSFI-6).
timeFrame: 6 - 24 months
measure: Sexual functioning in men assessed by the Sexual Health Inventory in Men (SHIM).
timeFrame: 6 - 24 months
measure: Anxiety severity assessed by the GAD-7.
timeFrame: 6 - 24 months
measure: Relationship satisfaction as assessed by the Dyadic Adjustment Scale (DAS-32).
timeFrame: 6 - 24 months
measure: Center for Epidemiologic Studies Depression Scale (CES-D).
timeFrame: 6 - 24 months
measure: Satisfaction with Life Scale (SWLS).
timeFrame: 6 - 24 months
measure: Brief Illness Perception Questionnaire (IPQ).
timeFrame: 6 - 24 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
Study officials:
References: