Breast Cancer, Prostate Cancer
Conditions
Keywords
Cancer, Feasibility trial, Physical activity, Home based exercise, Trial adherence
Brief summary
The purpose of this trial is to evaluate the feasibility of a home based exercise program for individuals with breast or prostate cancer patients undergoing active treatment.
Detailed description
This feasibility trial aims to assess a home-based exercise program, including a 3-month intervention of structured physical activity and health education for individuals with breast or prostate cancer. The main objective of this trial is to assess the adherence of cancer patients to a program of structured exercise, mixed with a health education approach, implemented and accompanied in a remote approach. The data collection will include variables related to: (a) recruitment and retentions rates; (b) attendance to exercise sessions; (c) fatigue and quality of life levels; (d) functional capacity levels; (e) adverse events related or not to the study; (f) patient selected outcomes.
Interventions
The intervention will be based on a remote approach, lasting 12 weeks. The training routine will consist of aerobic (walking), muscle strengthening and stretching exercises, with a frequency of three days per week. The contents related to the exercise prescription will be made available by phone call, text messages and short videos for exercise demonstration.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This a feasibility trial to assess a home-based exercise intervention individuals with breast or prostate cancer during treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* eighteen years old minimum; * be living in Porto Alegre or metropolitan region; * breast cancer stage 0 - III OR * localized prostate cancer; * undergoing hormonal treatment / manipulation in isolation or combined with other therapies three months prior to the entrance in the study; * hormonal therapy / manipulation planned to be active throughout the study duration; * not engaged in any exercise training for more than once a week for the past 6 months; * in case of previous surgical procedure, the patient must have medical clearance at the moment of the contact to begin the study or be cleared to do so in the near future (up to two weeks).
Exclusion criteria
* metastatic phase / progression of the disease or active regional location prior to beginning of the study; * inability to understand the terms and conditions of study due to language, hearing, cognitive or severe psychiatric issues; * another family member, who lives at the same residence, participating in the study; * planning to move or major absence (more than two weeks) during the study; * history of cardiovascular disease (except controlled hypertension) or severe cardiopulmonary disease, as well as history of heart attack, revascularization procedures, profound venous thrombosis, encephalic vascular accident (brain stroke) or pulmonary embolism in the past twelve months; * chronic pulmonary disease that requires oxygen or corticosteroid therapy; * kidney disease with or that is going to begin the use of dialysis or waiting for a kidney transplant; * severe nausea, anorexia or any other condition which does not allow to perform physical exercise; * medical contraindication to exercise training.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trial adherence | Up to12 weeks. | Proportion of self-reported exercise episodes (out of 36 episodes, total) during the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment yields | Up to 8 weeks before allocation to the study intervention. | Proportion of included participants (who signed the informed consent) in relation to the total number of screened individuals for eligibility. |
| Adverse events throughout the study | Up to 12 weeks. | Self-reported adverse events, related or not to the study. These measures will be mostly received by phone calls or text messaging. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Handgrip strength | Baseline; Week 12. | Maximum strength (in kgf) achieved by both hands in a handgrip test using a hand dynamometer. |
| Abdominal circumference | Baseline; Week 12. | Anthropometric measure of the highest abdominal circumference, using a metallic measuring tape. |
| Fatigue levels at baseline and at the end of the study | Baseline; Week 12. | Fatigue scores using specific questionnaires of Functional Assessment of Cancer Therapy (FACT questionnaire) for breast or prostate cancer patients. |
| Patient selected outcomes | Week 12. | Through the development of the study, participants will be asked to engage in a focal group to discuss outcomes relevant to be assessed in trials with exercise interventions targeted for patients with breast or prostate cancer. |
| Physical activity levels | Single assessment at baseline. | Physical activity calculated in minutes and intensity per week, of physical activity using the International Physical Activity Questionnaire (IPAQ). |
| Quality of life, based on the Functional Assessment of Cancer Therapy (FACT questionnaire) | Baseline; Week 12. | Quality of life scores using specific questionnaires of FACT (Functional Assessment of Cancer Therapy) for breast or prostate cancer patients. |
| Walking capacity | Baseline; Week 12. | Total distance (in meters) performed during the six minute walk test. |
Countries
Brazil
Contacts
Primary ContactDaniel Umpierre de Moraes, PhD
Backup ContactLarissa Xavier Neves da Silva, Master
Outcome results
None listed