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Spots Global Cancer Trial Database for Adaptations to Breast Cancer and Exercise Using Telehealth (ABRACE: Telehealth)

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Trial Identification

Brief Title: Adaptations to Breast Cancer and Exercise Using Telehealth (ABRACE: Telehealth)

Official Title: A Multicomponent Exercise Intervention Using Telehealth to Improve Psychological and Physical Outcomes in Breast Cancer Patients Undergoing Primary Treatment: A Randomized Controlled Trial

Study ID: NCT04641377

Study Description

Brief Summary: The aim of the present study is to determine the effects of 12 weeks of multicomponent training associated with a health education program carried out remotely, compared to a health education-only program, on psychological and physical outcomes of women in primary treatment for breast cancer. For that, 36 women will be randomized to a multicomponent training group carried out remotely associated with health education or health education group. The psychological and physical outcomes will be measured pre (week 0) and post-intervention (week 13) in both groups, always by the same investigator blinded in relation to the groups. The multicomponent training group will carry out an exercise program twice a week, and health education will also be carried out on one of the two days. In this group, the conversation on the topic of the week will take place during stretching. The sessions (on pre-established and non-consecutive days) will be held by video call (approximately 60 min) in small groups (maximum three participants) and will be given by students of the Physical Education course, previously trained to perform the intervention. The order of the multicomponent training will be joint mobilization, aerobic stimulus, balance exercise, strength exercises and stretching of the main muscles used during the training session. For the participants of the health education group, also, once a week, a material with several topics related to the management of breast cancer diagnosis and physical activity will be sent by message. In addition, two days after this material is sent, a conversation will be held with the participants of this group, at a google meet of approximately 30 minutes, about the theme sent by message. The themes will be depression, pain, fatigue, body image, symptoms in the arm and breast, vasomotor symptoms, neuropathy, arthralgia, sexual dysfunction, quality of life, physical activity and eating habits. To analyze the outcomes collected, it will be used Generalized Estimating Equations (GEE) and the Bonferroni post-hoc test.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

UFPel, Pelotas, Rio Grande Do Sul, Brazil

UFRGS, Porto Alegre, Rio Grande Do Sul, Brazil

Contact Details

Name: Stephanie S Pinto, PhD

Affiliation: Federal University of Pelotas

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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