MelanomaNCT03825913
3-month Aerobic and Resistance Exercise Intervention for Individuals Diagnosed With Melanoma
A study testing Exercise Intervention and Wellness Intervention in people with Melanoma, run by University of Miami at 1 site in United States.
Trial summary
Our proposed study will focus on addressing the feasibility, safety and benefits of a 3-month exercise intervention among individuals diagnosed with melanoma. The study will be conducted at University of Miami Miller School of Medicine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Exercise Intervention and Wellness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2019to 21 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion criteria: (a) men and women (≥ 18 years of age) with a diagnosis of melanoma cancer within one year from diagnosis, (b) not meeting the guidelines for physical activity (less than 150 minutes of moderate intensity activity or 75 minutes of vigorous intensity activity a week for 6 weeks prior the enrollment) (c) a commitment to two weekly supervised exercise sessions or bi-monthly educational sessions for three months at University of Miami Miller School of Medicine (d) and able to understand, read and write English.
Exclusion criteria: (a) participants for whom physical activity is contraindicated because of comorbid conditions, (b) participants with dementia, altered mental status or psychiatric condition and (c) participants who are unwilling or unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Safety Profile of a 3-month Aerobic and Resistance Exercise Intervention for Individuals Diagnosed With Melanoma
Our proposed study will focus on addressing the feasibility, safety and benefits of a 3-month exercise intervention among individuals diagnosed with melanoma.
The study will be conducted at University of Miami Miller School of Medicine. Eligible participants (n=24) will be randomized into 3 months of wellness education (n=12) or structured exercise (n=12).
Read the detailed description
Our proposed study will focus on addressing the feasibility, safety and benefits of a 3-month exercise intervention among individuals diagnosed with melanoma.
The study will be conducted at University of Miami Miller School of Medicine. The eligible participants will meet the following inclusion and exclusion criteria.
Inclusion criteria: (a) men and women (≥ 18 years of age) with melanoma cancer within one year from diagnosis, (b) not meeting the guidelines for physical activity (less than 150 minutes of moderate intensity activity or 75 minutes of vigorous intensity activity a week for 6 weeks prior the enrollment) (c) a commitment to two weekly supervised exercise sessions or bi-monthly educational sessions for three months at University of Miami Miller School of Medicine and (d) able to understand, read and write English.
Exclusion criteria: (a) participants for whom physical activity is contraindicated because of comorbid conditions, (b) participants with dementia, altered mental status or psychiatric condition and (c) participants who are unwilling or unable to provide informed consent.
The participants (n=24) will be randomized into 3 months of: 1) wellness education (n=12) or 2) structured exercise (n=12). All participants will receive standard treatment as directed by their oncologists. Individuals in the wellness education group will attend bi-monthly sessions where they will receive general wellness information pertaining to physical activity, nutrition, sleep, weight management and mindfulness. Individuals in the structured exercise group will attend supervised exercise sessions twice per week and receive a tailored daily walking plan using physical activity trackers. A comprehensive assessment will be conducted at baseline and 3-months, which will include demographics, medical and treatment history, anthropometrics, quality of life, physical fitness, past and current sun exposure, fatigue, and nutritional status. We plan the following specific aims:
Aim 1: To assess feasibility, adherence, and safety of a 3-month supervised exercise program in melanoma patients.
Aim 2: To evaluate the impact of a 3-month supervised exercise program on quality of life in melanoma patients.
Aim 3: To evaluate the effect of a 3-month supervised exercise program on cardiorespiratory fitness and muscular strength in melanoma patients.
- Conditions
- Melanoma
- Being tested
- Exercise Intervention, Wellness Intervention
- Keywords
- Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Training sessions will include a split routine based on the day of the week.
- Session 1 (e.g. Tuesday) - aerobic exercise (20-30 min) followed by resistance training (10 stacked-weight machines: leg press, leg extension, leg curl, chest press, latissimus pull, shoulder press, seated row, triceps press, biceps curl, and chest fly) for 1-2 sets of 8-12 repetitions.
- Session 2 (e.g. Thursday) - resistance bands and body weight exercises (4-6 exercises, 2 sets of 10-20 repetitions) followed by core exercises (2-3 sets of 10-20 repetitions) and aerobic training (20-30 min) at the end.
The starting training intensities will be at 50-55% of each individual's estimated maximum heart rate for aerobic exercise and one-repetition maximum for resistance training (assessed at baseline only for chest press and leg press). We plan a 5% monthly increase in the intensity to reach 65-70%% of one's maximum efforts by the end of the intervention.
Wellness InterventionBehavioural
In our setting, ten lectures in nutrition, exercise and various complementary and integrative medicine topics (e.g. acupuncture and Chinese medicine, mindfulness, quality sleep, etc.) were implemented among non-cancer individuals and modified based on their feedback.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Active comparator | Subjects in the exercise group will participate in a 3-month exercise program at the University of Miami UHealth Fitness and Wellness Center. Participants will complete two exercise sessions a week, each 45-60 minutes long and on a one-on-one basis.
In addition to two site visits, the participants will receive a tailored daily home-based walking plan. The participants will use physical activity trackers (Fitbit®), with an ultimate goal of achieving 10,000 steps by the end of the intervention.
Participants in the exercise intervention will complete 24 sessions. Receives: Behavioral: Exercise Intervention |
| Wellness Intervention | Sham comparator | For 3 months, the wellness education group will not be offered any form of supervised exercise program or receive any specific instructions on physical activity as part of the study. The participants in this group will attend educational sessions about different wellness topics, such as nutrition, sleep, weight management, mindfulness, and the overall benefits of increased physical activity. The wellness visits will be held two times per month, and similar to the exercise sessions of the intervention arm, they will be 45-60 minutes long and on a one-on-one basis. Participants in the wellness education group will complete 6 sessions. Receives: Behavioral: Wellness Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Assessment
Less than 20% attrition rate for the intervention group
Measured: 12 weeks
Adherence Assessment
80% or higher of the exercise sessions completed
Measured: 12 weeks
Secondary outcomes (7)
FACT-M (Functional Assessment of Cancer Therapy - Melanoma)
Quality of Life
Measured: 6 and 12 weeks
6-minute Walk Test
Cardiorespiratory Fitness
Measured: 12 weeks
Hand Grip
Muscular Strength
Measured: 12 weeks
30-sec Chair Stand
Functional Status
Measured: 12 weeks
Food Frequency Questionnaire
Nutritional Intake
Measured: 12 weeks
SEBI (Sun Exposure and Behavior Inventory)
Sun Exposure
Measured: 12 weeks
FACIT (Functional Assessment of Chronic Illness Therapy
Fatigue
Measured: 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start6 Nov 2019
- Primary completion21 Feb 2020
- Study completion21 Feb 2020
Why it stopped: two key faculty members are no longer part of the study and institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduard Tiozzo, PhD, University of Miami
- Investigators
- Eduard Tiozzo, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825913
- Sponsor's protocol ID
- 20180174
- Status last verified
- Aug 2020
- First submitted
- 30 Jan 2019
- Last updated
- 28 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety Profile of a 3-month Aerobic and Resistance Exercise Intervention for Individuals Diagnosed With Melanoma
- ClinicalTrials.gov ID
- NCT03825913
- Acronym / sponsor ID
- 20180174
- Conditions
- Melanoma
- Keywords
- Melanoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: two key faculty members are no longer part of the study and institution
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our proposed study will focus on addressing the feasibility, safety and benefits of a 3-month exercise intervention among individuals diagnosed with melanoma.
The study will be conducted at University of Miami Miller School of Medicine. Eligible participants (n=24) will be randomized into 3 months of wellness education (n=12) or structured exercise (n=12).
Detailed description
Our proposed study will focus on addressing the feasibility, safety and benefits of a 3-month exercise intervention among individuals diagnosed with melanoma.
The study will be conducted at University of Miami Miller School of Medicine. The eligible participants will meet the following inclusion and exclusion criteria.
Inclusion criteria: (a) men and women (≥ 18 years of age) with melanoma cancer within one year from diagnosis, (b) not meeting the guidelines for physical activity (less than 150 minutes of moderate intensity activity or 75 minutes of vigorous intensity activity a week for 6 weeks prior the enrollment) (c) a commitment to two weekly supervised exercise sessions or bi-monthly educational sessions for three months at University of Miami Miller School of Medicine and (d) able to understand, read and write English.
Exclusion criteria: (a) participants for whom physical activity is contraindicated because of comorbid conditions, (b) participants with dementia, altered mental status or psychiatric condition and (c) participants who are unwilling or unable to provide informed consent.
The participants (n=24) will be randomized into 3 months of: 1) wellness education (n=12) or 2) structured exercise (n=12). All participants will receive standard treatment as directed by their oncologists. Individuals in the wellness education group will attend bi-monthly sessions where they will receive general wellness information pertaining to physical activity, nutrition, sleep, weight management and mindfulness. Individuals in the structured exercise group will attend supervised exercise sessions twice per week and receive a tailored daily walking plan using physical activity trackers. A comprehensive assessment will be conducted at baseline and 3-months, which will include demographics, medical and treatment history, anthropometrics, quality of life, physical fitness, past and current sun exposure, fatigue, and nutritional status. We plan the following specific aims:
Aim 1: To assess feasibility, adherence, and safety of a 3-month supervised exercise program in melanoma patients.
Aim 2: To evaluate the impact of a 3-month supervised exercise program on quality of life in melanoma patients.
Aim 3: To evaluate the effect of a 3-month supervised exercise program on cardiorespiratory fitness and muscular strength in melanoma patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Active comparator | Behavioral: Exercise InterventionSubjects in the exercise group will participate in a 3-month exercise program at the University of Miami UHealth Fitness and Wellness Center. Participants will complete two exercise sessions a week, each 45-60 minutes long and on a one-on-one basis. In addition to two site visits, the participants will receive a tailored daily home-based walking plan. The participants will use physical activity trackers (Fitbit®), with an ultimate goal of achieving 10,000 steps by the end of the intervention. Participants in the exercise intervention will complete 24 sessions. |
| Wellness Intervention | Sham comparator | Behavioral: Wellness InterventionFor 3 months, the wellness education group will not be offered any form of supervised exercise program or receive any specific instructions on physical activity as part of the study. The participants in this group will attend educational sessions about different wellness topics, such as nutrition, sleep, weight management, mindfulness, and the overall benefits of increased physical activity. The wellness visits will be held two times per month, and similar to the exercise sessions of the intervention arm, they will be 45-60 minutes long and on a one-on-one basis. Participants in the wellness education group will complete 6 sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionTraining sessions will include a split routine based on the day of the week. * Session 1 (e.g. Tuesday) - aerobic exercise (20-30 min) followed by resistance training (10 stacked-weight machines: leg press, leg extension, leg curl, chest press, latissimus pull, shoulder press, seated row, triceps press, biceps curl, and chest fly) for 1-2 sets of 8-12 repetitions. * Session 2 (e.g. Thursday) - resistance bands and body weight exercises (4-6 exercises, 2 sets of 10-20 repetitions) followed by core exercises (2-3 sets of 10-20 repetitions) and aerobic training (20-30 min) at the end. The starting training intensities will be at 50-55% of each individual's estimated maximum heart rate for aerobic exercise and one-repetition maximum for resistance training (assessed at baseline only for chest press and leg press). We plan a 5% monthly increase in the intensity to reach 65-70%% of one's maximum efforts by the end of the intervention. | Behavioural | Exercise Intervention |
| Wellness InterventionIn our setting, ten lectures in nutrition, exercise and various complementary and integrative medicine topics (e.g. acupuncture and Chinese medicine, mindfulness, quality sleep, etc.) were implemented among non-cancer individuals and modified based on their feedback. | Behavioural | Wellness Intervention |
Primary outcome
Feasibility Assessment
Time frame: 12 weeks
Less than 20% attrition rate for the intervention group
Adherence Assessment
Time frame: 12 weeks
80% or higher of the exercise sessions completed
7 secondary outcomes
FACT-M (Functional Assessment of Cancer Therapy - Melanoma)
Time frame: 6 and 12 weeks
6-minute Walk Test
Time frame: 12 weeks
Hand Grip
Time frame: 12 weeks
30-sec Chair Stand
Time frame: 12 weeks
Food Frequency Questionnaire
Time frame: 12 weeks
SEBI (Sun Exposure and Behavior Inventory)
Time frame: 12 weeks
FACIT (Functional Assessment of Chronic Illness Therapy
Time frame: 6 and 12 weeks
Results and safety
The study was stopped early (reason given: two key faculty members are no longer part of the study and institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduard Tiozzo, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention and Wellness Intervention in people with Melanoma, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: two key faculty members are no longer part of the study and institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Assessment (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.