A Trial of a Multimodal Lifestyle Intervention to Optimize Survivorship After Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-19

Study Completion Date

2025-12-31

Brief Summary

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To examine the efficacy of a 10-week multimodal lifestyle program, versus waitlist control, on cardiorespiratory fitness capacity and body weight in survivors of cancer.

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Detailed Description

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Conditions

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Neoplasm Malignant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Multimodal Lifestyle Program

The multimodal lifestyle program will utilize intensive behavioral therapy with structured exercise training and nutritional counseling. The main objective of the structured exercise training is to improve cardiorespiratory fitness.

Group Type EXPERIMENTAL

Multimodal Lifestyle Program

Intervention Type BEHAVIORAL

The multimodal lifestyle program will utilize intensive behavioral therapy with structured exercise training and nutritional counseling.

Waitlist Control

The waitlist control group will be asked to maintain their current exercise and dietary habits for the 10-week study period. Upon providing study endpoint data at week 10, control group participants will be offered a 4-week multimodal lifestyle program that is similar to the intervention group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Multimodal Lifestyle Program

The multimodal lifestyle program will utilize intensive behavioral therapy with structured exercise training and nutritional counseling.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Ability to provide informed consent before any trial-related activities
* History of any malignancy
* Completion of cancer-directed therapy (e.g., surgery, chemotherapy, and radiotherapy) prior to enrollment (patients receiving ongoing endocrine or targeted therapy are eligible to participate)
* No evidence of residual or recurrent cancer under active treatment
* Age ≥18 years
* Body mass index (BMI) ≥30 kg/m2 or BMI ≥27 kg/m2 with one or more treated or untreated weight-related coexisting conditions
* Willing to be randomized
* Allow the collection and storage of biospecimens and data for future use

Exclusion Criteria

* Engaging in ≥3 purposeful exercise sessions per week, on average, over the past 12 weeks
* Significant purposeful weight loss (\>11 kg) within the past 12 weeks
* Current use of medications or devices for the purpose of weight loss
* Metabolic or bariatric surgery within the last year
* Cardiovascular, respiratory, or musculoskeletal disease that would prohibit participation in an exercise and weight loss program
* Currently pregnant, breastfeeding, or planning to become pregnant with the next 12 weeks
* Psychiatric disorders or conditions that would preclude participation in the study intervention
* Any other condition which, in the opinion of the investigator, may impede testing of the study hypothesis or make it unsafe to engage in the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No