Clinical trial NCT03825913: 3-month Aerobic and Resistance Exercise Intervention for Individuals Diagnosed With Melanoma
Official title: Feasibility and Safety Profile of a 3-month Aerobic and Resistance Exercise Intervention for Individuals Diagnosed With Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Melanoma
Keywords: Melanoma
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility Assessment
timeFrame: 12 weeks
measure: Adherence Assessment
timeFrame: 12 weeks
Secondary outcomes:
measure: FACT-M (Functional Assessment of Cancer Therapy - Melanoma)
timeFrame: 6 and 12 weeks
measure: 6-minute Walk Test
timeFrame: 12 weeks
measure: Hand Grip
timeFrame: 12 weeks
measure: 30-sec Chair Stand
timeFrame: 12 weeks
measure: Food Frequency Questionnaire
timeFrame: 12 weeks
measure: SEBI (Sun Exposure and Behavior Inventory)
timeFrame: 12 weeks
measure: FACIT (Functional Assessment of Chronic Illness Therapy
timeFrame: 6 and 12 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Eduard Tiozzo, PhD
role: PRINCIPAL_INVESTIGATOR
References: