Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Nutritional and Metabolic Diseases

Prostatic Neoplasms

Metabolic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Pelvic floor exercise program and general exercise programming

Pelvic floor exercises and standard care (physical activity counseling)

General exercises will be prescribed along with a specialized pelvic floor program

Pelvic floor exercise program

A general progressive resistance exercise program

General exercise

Physical Activity Counseling

Margaret L McNeely

Chris Sellar

Margaret McNeely

Nathan Hoy, MD

Howard Evans, MD

The Continence, Sexual and Metabolic Health (CONTROL 4 LIFE) study will evaluate the recovery of continence, sexual function, and health outcomes in individuals who have undergone surgery for prostate cancer. The purpose of this study is to better understand the timelines of recovery for these outcomes after surgery for prostate cancer. As part of this study, all participants will receive resources offered by Alberta Health Services regarding pre- and post-prostatectomy care, including information on pelvic floor exercises. Through the CONTROL 4 LIFE study, the investigators will also be evaluating outcomes related to physical activity, fitness and quality of life. These assessments will enable the investigators to better understand how well and how long it takes for individuals to recover after surgery for prostate cancer.

The investigators aim to conduct a trial examining the feasibility and the effects of a combined pelvic health rehabilitation and exercise program that can be delivered both in-person and virtually in individuals who have been treated with prostatectomy for prostate cancer. This hybrid format will support equitable program delivery regardless of location of residence. To address issues faced by men with prostate cancer, the investigators propose an intervention (offered virtually and in-person) that includes: 1) online education to support continence, sexual and overall health; 2) a group exercise fitness program that considers the needs and restrictions specific to the early post-prostatectomy surgical period, and 3) functional and intensive pelvic floor muscle exercise retraining to promote continence and sexual recovery.

Main objectives of this study

1. Determine the feasibility, defined as the acceptability and appropriateness, of a combined pelvic health rehabilitation and exercise fitness program that can be delivered both in-person and virtually.
2. Determine the effects of the program on the primary outcome measure of urinary continence in comparison with usual care.

Secondary objectives of this study

1. To determine the effects of the program on cardiometabolic indicators in comparison with usual care.
2. To determine the effects of the program on general fitness, secondary outcomes of urinary continence, sexual function, self-efficacy, and cancer symptom burden, in comparison with usual care.

The participants will be randomized after the baseline assessment and will have the option to take part in an additional exercise intervention component.

Continence, Sexual Function, Fitness and the Health of Men After Surgery for Prostate Cancer

Continence, Sexual and Metabolic Health Programming to Promote Prostate Cancer Wellness for Life (CONTROL4LIFE)

Data will be housed on the University of Alberta's Dataverse

The number of participants completing the study including all planned outcomes

Percentage of participants who are eligible and agree to participate

Mean: Individual's urine loss by measuring weight (grams) of an absorbent pad

16-questions: urinary function, sexual and erectile function, bowel and hormonal function; Scores: 0 (no symptoms) to 60 (most severe symptoms); Higher scores indicate worse functioning

13 questions: occurrence and bother of lower urinary tract symptoms, quality of life; Range of scores: 0-20 voiding subscale; 0-20 incontinence symptoms; Higher scores indicate worse functioning

Quality of life measure: Items are scored 0-100 (percentage of total possible score): Higher scores equal better quality of life

11-item ordinal scale; Range 0-60; with higher scores indicating higher symptom burden

6 item ordinal scale: Range 0-60; Higher scores indicating higher self-efficacy

Sit-to-stand: mean number completed in 30 seconds

Shoulder Range of Motion: mean value in degrees

One-leg stance test: mean time in seconds

Six-minute walk test: mean distance in metres

Height and weight will be combined to calculate BMI: mean: weight in kilograms divided by height in metres squared

University of Alberta

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants in this group will take part the general exercise program delivered through the Active Living module of the HEAL-ME application. The program comprises (1) supervised group exercise sessions (connection via zoom platform embedded in HEAL-ME), (2) independent exercise workouts within the application, and (3) exercise specific education within the Education Module of the HEAL-ME application.

Participants in this group will take part in an integrated physiotherapy and exercise intervention delivered through the Active Living module of the HEAL-ME application. The program comprises (1) supervised group physiotherapeutic exercise sessions (connection via zoom platform embedded in HEAL-ME), (2) independent physiotherapeutic exercise workouts, and (3) breast cancer specific physiotherapy education delivered through weekly modules.

A 10-week integrated physiotherapy and general exercise intervention compared to a general exercise intervention alone.

general exercise

Margaret McNeely, PhD

Margaret L. McNeely, PhD

The primary purpose of this study is to determine the feasibility of our proposed intervention approach involving (1) an integrated physiotherapy and exercise intervention for individuals with breast cancer who are undergoing chemotherapy and (2) delivery of programming via an electronic health (eHealth) application. The secondary objective is to determine the efficacy of the program on upper extremity outcomes, general physical fitness, cancer treatment-related symptoms and quality of life.

EMPOWER is a multi-methods feasibility randomized controlled trial. The study will recruit a minimum of 30 individuals with breast cancer who are undergoing adjuvant chemotherapy following surgery for breast cancer. The study will be conducted in two phases:

Phase I: Randomized Controlled Feasibility Trial The aim of this phase is to determine the feasibility and preliminary efficacy of a 10-week integrated physiotherapy and exercise intervention compared to an exercise intervention alone.

Phase II: Qualitative Study The aim of this phase is to evaluate the acceptability of the Healthy Eating, Active Living and Mindful Energy (HEAL-ME) Research App design, program delivery, program components and perceived effectiveness of the intervention at the level of the participant.

PHASE I: Randomized Controlled Feasibility Trial A randomized controlled trial design will be used to randomize individuals with breast cancer to one of two groups: 1) Comparison group: general exercise intervention + education; and 2) Experimental group: integrated physiotherapy and general exercise intervention + education. The study will be carried out over a 10-week period. The outcome measures will be assessed at baseline and at 10 weeks.

Randomization: An independent researcher will generate the randomization sequence using a computer-generated randomization module within the Trial's REDCap database. Randomization will occur following baseline testing.

Interventions:

Group 1 (Comparator): Hybrid In-Persona and HEAL-ME delivered General Exercise:

Participants in this group will take part the general exercise program delivered in-person and through the Active Living module of the HEAL-ME application. The program comprises (1) supervised group exercise sessions in-person or virtually (2) independent exercise workouts within the application, and (3) exercise specific education within the Education Module of the HEAL-ME application. Exercise regimen: The exercise regimen follows the general principles of overload, progression, and specificity. The exercise program consists of full body exercise (e.g., comprising aerobic, resistance training, core stability, balance and flexibility training) a minimum of 2 times per week (one group virtual session and one independent self-directed session). Education: educational materials in written (PDF format) will be included in the Education module: resources section of the HEAL-ME application. Topics include the exercise expectations, behavior change strategies, home exercise equipment and how to exercise safely.

Group 2 (Experimental): Hybrid in-person and HEAL-ME Integrated Physiotherapy and exercise:

Participants in this group will take part in an integrated physiotherapy and exercise intervention delivered in-person and through the Active Living module of the HEAL-ME application. The program comprises (1) supervised group physiotherapeutic exercise sessions in-person or virtually, (2) independent physiotherapeutic exercise workouts, and (3) breast cancer specific physiotherapy education delivered through weekly modules. Integrated physiotherapy and exercise regimen: The integrated physiotherapy and exercise regimen will follow the exercise regimen as described in Group 1. For this group, breast cancer specific shoulder range of motion and stretching exercises will be incorporated into the warm-up and cool-down components of both group and individual exercise sessions. Education: educational videos will be available on the application and include topics such as cancer-related fatigue, risk reduction for lymphedema and pelvic health after breast cancer.

Educational materials in written (PDF format) will be included in the Education module: resources section of the HEAL-ME application. Topics include the benefits of exercise during chemotherapy for breast cancer, exercise behavior change strategies, and how to exercise safely.

Blinding An independent assessor, who is blinded to the group assignment will carry out all the measurements. Training of the assessor will be conducted on the measurement procedures related to the upper body and fitness outcome measurement protocols prior to study initiation.

PHASE II: Assessment of HEAL-ME App Design, Acceptability, and Program Components The app design, acceptability, and program components will be assessed following completion of the study through focus groups and semi-structured interviews to explore the experiences of individuals randomized to the HEAL-ME experimental group. The purpose of this phase is to assess different aspects of HEAL-ME related to the program delivery, different components contents, and time commitment. The results of this phase will inform further development of the HEAL- ME breast cancer module.

Phase II Data Collection Focus Groups: E-intervention group participants will be invited to participate in a focus group or semi-structured interview session that aim to capture participant perspectives and experiences, as well as any facilitators or barriers to use of the HEAL-ME application.

Qualitative Data Analysis The focus groups discussions will be audio recorded and transcribed. Two researchers will read and then reread the transcripts for accuracy against the audio recordings. The investigators will conduct an inductive content analysis to capture the participants' views about the program's acceptability and usability and ways to refine it. The inductive approach will enable a descriptive evaluation of the program from the participant's view. Two researchers will independently analyze the content of the focus group transcripts to identify evidence related to research objectives. Using the thematic analytic approach, the investigators will follow different processes described by Braun and Clarke. The data will be analyzed line by line by the researchers independently to identify patterns and key themes with example quotes from the data. Codes for similar meanings and highlighted terms will be developed, examined, and refined if necessary to identify the most expressive codes related to the research objectives. The process will be repeated a few times until concrete themes emerge and no further themes are identified. The generated themes will be reviewed and verified by a third researcher in order to increase the validity of the findings. Any coding discrepancies will be discussed and reconciled. Conceptual themes will be inductively originated from analysis through generating initial codes, followed by sub-themes, and finally, an overarching theme.

Independent assessors will be used for collection of objective outcomes. The independent assessors will be blinded to group allocation.

Exercise Rehabilitation Via a Mobile Application for Individuals With Breast Cancer Undergoing Chemotherapy

Exercise Rehabilitation Via a Mobile Application for Individuals With Breast Cancer Undergoing Chemotherapy (EMPOWER): A Randomized Controlled Feasibility Trial

On completion of the trial, data will be available through the University of Alberta's Dataserve

Defined as \>70% participants completing at least 70% of exercise sessions and the post-study assessment

Percentage of participants eligible who consent to participate in the study

Percentage of completed exercise and education modules

Functional Assessment of Cancer Therapy -breast (FACT-B+4)

Functional Assessment of Cancer Therapy - fatigue subscale (FACIT-F)

Godin Leisure Time Exercise Questionnaire

Active Shoulder Range of Motion: abduction

Active Shoulder Range of Motion: external rotation

Active Shoulder Range of Motion: internal rotation

Active Shoulder Range of Motion: horizontal abduction

Perometry for the measurement of lymphedema

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Continence, Sexual Function, Fitness and the Health of Men After Surgery for Prostate Cancer	NCT06072911	Prostate Cancer Incontinence Metabolic Disea...	Pelvic floor ex... General exercis... Physical Activi...	18 Years -	University of Alberta
Exercise Rehabilitation Via a Mobile Application for Individuals With Breast Cancer Undergoing Chemotherapy	NCT05254678	Breast Cancer Upper Extremity...	general exercis...	18 Years -	University of Alberta

Spots Global Cancer Trial Database for general exercise