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Clinical Trials/NCT04641377
NCT04641377
Unknown
N/A

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

Federal University of Pelotas2 sites in 1 country36 target enrollmentFebruary 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast Cancer Female
Sponsor
Federal University of Pelotas
Enrollment
36
Locations
2
Primary Endpoint
Change from Baseline Cancer-related fatigue at 3 months
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2021
End Date
March 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Federal University of Pelotas
Responsible Party
Principal Investigator
Principal Investigator

Stephanie Santana Pinto

Principal investigator

Federal University of Pelotas

Eligibility Criteria

Inclusion Criteria

  • Women from the city of Porto Alegre and Pelotas in southern Brazil
  • Women diagnosed with breast cancer in stages I-III
  • Women undergoing primary treatment (adjuvant or neoadjuvant chemotherapy or only radiotherapy) of breast cancer
  • Women can not be practicing periodized and systematic physical exercise programs

Exclusion Criteria

  • Women can not have reached more than 50% of the completion of chemotherapy or only radiotherapy treatment
  • Women can not have the following comorbidities:
  • autonomic neuropathy or severe peripheral neuropathy, proliferative diabetic retinopathy, non-proliferative diabetic retinopathy, uncompensated heart failure, unstable angina, peripheral amputations, uncontrolled arterial hypertension, chronic renal failure, severe psychiatric disorders and musculoskeletal impairment that limits physical exercise.

Outcomes

Primary Outcomes

Change from Baseline Cancer-related fatigue at 3 months

Time Frame: Baseline and post-intervention (week 13)

Fatigue will be determined using the behavioural/severity, affective, sensory, cognitive/mood, and total fatigue scores from the Piper Fatigue Scale through an interview. Its version translated into Portuguese is a reliable and valid instrument to measure fatigue in Brazilian cancer patients. This consists of 22 items numerically scaled 0 to 10 that measure the 4 dimensions of subjective fatigue as well as total fatigue.

Secondary Outcomes

  • Change from Baseline Quality of life (QoL) of Cancer Patients at 3 months(Baseline and post-intervention (week 13))
  • Change from Baseline Quality of life (QoL) of Breast cancer patients specific supplement at 3 months(Baseline and post-intervention (week 13))
  • Change from Cancer-related cognitive impairment at 3 months(Baseline and post-intervention (week 13))
  • Change from Depressive symptoms at 3 months(Baseline and post-intervention (week 13))
  • Change from Anxiety at 3 months(Baseline and post-intervention (week 13))
  • Change from Functional capacity at 3 months(Baseline and post-intervention (week 13))
  • Change from Level of leisure-time physical activity at 3 months(Baseline and post-intervention (week 13))

Study Sites (2)

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