Cancer Patient Empowerment Program: Phase 2 Feasibility Study

Cancer Clinical Trial

— CancerPEP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05508412
• Other study ID #: CancerPEP-Phase2-Protocol
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 6, 2022
• Est. completion date: March 15, 2025

Study information

• Verified date: April 2024
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: March 15, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• CancerPEP
CancerPEP

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	Dalhousie University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mental Health as assessed by the Kessler Kessler Psychological Distress Scale (K10)	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
Secondary	General Health (Physical and Mental) Quality of Life assessed by the 12-item Short Form Health Survey (SF-12)	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
Secondary	Health-Related Quality of Life as assessed by the Functional Assessment of Cancer Therapy - General (FACT-G)	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
Secondary	Personality as assessed by the Ten-Item Personality Inventory (TIPI)	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
Secondary	Alcohol Habit assessed by questions from the NIH Alcohol Consumption questionnaire.	Questions assessing alcohol consumption	6 - 24 months
Secondary	Smoking habit assessed by the Global Adult Tobacco Survey 2020 (GATS).	Questions assessing smoking use	6 - 24 months
Secondary	Diet assessed by the Rapid Eating Assessment for Participants (REAP-S).	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
Secondary	Comorbidity level assessed by the modified Charlson Comorbidity Index (CCI)	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
Secondary	Availability of social support assessed by the MOS Social Support Survey	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
Secondary	Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)	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
Secondary	Sedentary behaviour measured by the Sedentary Behaviour Questionnaire (SBQ) for Adults.	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
Secondary	Sexual functioning in women assessed by the 6-item Female Sexual Function Index (FSFI-6).	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
Secondary	Sexual functioning in men assessed by the Sexual Health Inventory in Men (SHIM).	A 5-item questionnaire with scores ranging from 1-25 and lower scores indicating worse sexual functioning.	6 - 24 months
Secondary	Anxiety severity assessed by the GAD-7.	A 7 item questionnaire with scores ranging from 0-21 higher scores indicating more severe level of anxiety.	6 - 24 months
Secondary	Relationship satisfaction as assessed by the Dyadic Adjustment Scale (DAS-32).	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
Secondary	Center for Epidemiologic Studies Depression Scale (CES-D).	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
Secondary	Satisfaction with Life Scale (SWLS).	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
Secondary	Brief Illness Perception Questionnaire (IPQ).	A 9 item sale that measures an individual's beliefs, feelings, and cognitive representations of one's illness.	6 - 24 months