Home-Combo: an Online Home-based Combined Exercise Intervention for Women With Breast Cancer

NCT06429189 | Not Yet Recruiting

• 1 other identifier: Home-Combo
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Background. Chemotherapy drugs carry many side effects that may hinder the functional performance of women with breast cancer (BC). Chemoresistance can lead to treatment failure. A relative dose intensity of chemotherapy \<85% is associated with a worse diagnosis and lower treatment efficacy. Exercise may modulate treatment response through its effects on the tumor microenvironment and treatment tolerability. The need for a pleasant and sustainable exercise practice is important, considering the psychological and physiological stress that accompanies women with a BC diagnosis during treatment. Studies investigating the effects of exercise interventions on chemotherapy completion rates are needed. Background. Chemotherapy drugs carry many side effects that may hinder the functional performance of women with breast cancer (BC). Chemoresistance can lead to treatment failure. A relative dose intensity of chemotherapy \<85% is associated with a worse diagnosis and lower treatment efficacy. Exercise may modulate treatment response through its effects on the tumor microenvironment and treatment tolerability. The need for a pleasant and sustainable exercise practice is important, considering the psychological and physiological stress that accompanies women with a BC diagnosis during treatment. Studies investigating the effects of exercise interventions on chemotherapy completion rates are needed. Purpose. This study will be a 2-arm pragmatic randomized controlled trial, Home-Combo, which will target Portuguese women with a breast cancer diagnosis undergoing either neo-adjuvant or adjuvant chemotherapy. The Home-Combo study primarily aims to investigate the effects of a structured, supervised, home-based combined exercise intervention with self-selected intensity, conducted across the chemotherapy treatment period, on the chemotherapy completion rates of women with BC. Secondly, this study intends to analyze the impact of this intervention on functional performance, body composition, PA levels, and quality of life. A 3-month follow-up will be performed to investigate short-term outcomes and active lifestyle sustainability post-intervention. Methods. A 2-arm randomized controlled trial will be implemented in a real-world exercise setting to compare an online structured and supervised group aerobic and strength exercise intervention with an active control group during chemotherapy treatments. The study recruitment goal is 98 women with a BC diagnosis stage I-III who are scheduled to have neoadjuvant or adjuvant chemotherapy. Outcome measures will be obtained at baseline, mid-treatment (≈3 months), post-intervention (≈6 months), and 3-month follow-up. A mediation analysis will also be conducted. Hypothesis 1: Women in the intervention will have a better completion rate than those in the control group. Hypothesis 2: Women in the intervention will present better functional performance, body composition, PA levels, and quality of life than the control group. Hypothesis 3: In the post-intervention period, women in the intervention group will maintain a more physically active lifestyle than women in the control group.

Conditions

Breast Cancer; Chemotherapy Effect

Keywords

Breast cancer; Home-based exercise; Functional performance; Body composition; Physical activity; Quality of life

Outcome Measures

Primary Outcomes (1)

• Chemotherapy completion rates

  The outcome will be reported as the mean RDI (mg.m-2/wk-1), which corresponds to a fraction of the planned chemotherapy dose intensity, by dividing the dose of chemotherapy per square meter (of surface area where the drug is related) in each cycle by the number of weeks in a cycle. Information regarding the planned chemotherapy treatment and the effectively received treatment (i.e., dose, type, and duration) will be acquired from medical records after signing the informed consent 53,19. Successful chemotherapy completion rate will be considered if the RDI is ≥85% of the planned treatment. Calculations to compare the actual chemotherapy dose intensity received and the initially planned dose intensity will be calculated as total milligrams of chemotherapy divided by the product of the body surface (in square meters) and total weeks of treatment. The RDI results from the actual dose intensity received are divided by the planned dose intensity.

  Assessments will be performed at three time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months).

Secondary Outcomes (15)

• Functional performance

  Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)

• Functional performance

  Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)

• Functional performance

  Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)

• Functional performance

  Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)

• Functional performance

  Assessments will be performed at four time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months), 3 month follow-up (throughout the study completion up to 2 years)

Other Outcomes (3)

• Demographics

  Assessments will be performed at two time points: baseline (throughout recruitment period completion, 1 year), post-intervention (6-12 months)

• Physical activity history

  Assessments will be performed atbaseline (throughout recruitment period completion, 1 year)

• Medical history

  Assessments will be performed at three time points: baseline (throughout recruitment period completion, 1 year ), mid-treatment (3-6 months), post-intervention (6-12 months)

Study Arms (2)

Home-based combined exercise

EXPERIMENTAL

Exercise intervention will be led by qualified exercise professionals online via Zoom. It will consist of two weekly 60-minute online exercise group sessions: a 5-minute warm-up, 30-minute resistance training, and a 20-minute aerobic exercise component, finishing with a 5-minute cooldown. The warm-up will consist of mobility and activation movements. The resistance training component will consist of 9 exercises involving large muscle groups, performed with body weight or free weights. The exercises will be completed in 2-3 sets of 10-15 repetitions. The aerobic component will consist of low-impact dance exercises that move large muscle groups to increase heart rate. The cooldown will consist of breathing exercises and light stretches.

Behavioral: Home-based combined exercise program with self-selected intensity

Active control group

PLACEBO COMPARATOR

The control group will receive weekly 30-minute supervised sessions with breathing, stretching, relaxation exercises, and meditation.

Behavioral: Home-based combined exercise program with self-selected intensity

Interventions

Home-based combined exercise program with self-selected intensity BEHAVIORAL

Before the beginning of the exercise program, participants will receive an education session on how to use Borg's Perceived Rate of Exertion Scale (RPE) to monitor their effort during aerobic and resistance training and tips on when they may increase the exercise intensity. During the training sessions, participants in the intervention group will be asked to choose their preferred load to execute each exercise in the resistance component, told to perform the aerobic exercises at their preferred speed, and informed that they can stop exercising whenever they need to rest. The exercise professional may suggest increasing loads in specific exercises, but these increases will not be imposed on the participants. Attendance to the sessions in the intervention and control groups will be registered. Additionally, women in this group will be encouraged to perform brisk walking at their preferred intensity and receive a pedometer to increase walking motivation.

Also known as: Home-combo

Active control group; Home-based combined exercise

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer stage I-III diagnosis
• Scheduled to receive neoadjuvant or adjuvant chemotherapy
• Have acess to a computer

You may not qualify if:

• Medical conterindication to perform exercise or physical assessments due to concomitant comorbidity
• Non-controlled health conditions or diseases
• Psychological illness
• Currently enrolled in a structured exercise program
• Unable to complete the entire program (e.g., due to scheduled surgery or personal commitments)
• Pregnancy
• Worsening of clinical condition during intervention

Sponsors & Collaborators

• Grupo Lusófona: lead
• Universidade Lusófona de Humanidades e Tecnologias: collaborator
• Grupo HPA: collaborator
• Associação Oncológica do Algarve: collaborator
• Liga Portuguesa Contra o Cancro: collaborator
• Centro Hospitalar Universitario do Algarve: collaborator

Study Sites (1)

Universidade Lusófona, Centro de Lisboa

Lisbon, 1749-024, Portugal

Location

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MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Pedro B. Júdice, PhD

  CIDEFES

  STUDY DIRECTOR

• Eliana V. Carraça, PhD

  CIDEFES

  STUDY DIRECTOR

Central Study Contacts

Pedro GF Ramos, Msc

CONTACT

928159936; a22312606@alunos.ulht.pt

Pedro B. Júdice, PhD

CONTACT

217515500; p5274@ulusofona.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be told they are part of an exercise intervention without any mention of a control group. Healthcare professionals responsible for the chemotherapy prescription and administration and registering all clinical information will be blinded to the participants' groups. None of the research team members will know the number of participants, so data analysis will be performed in a blinded setting. If, at any given moment, a participant reveals her number to a research team member, all posterior data from that participant will be disregarded. If a participant decides to leave the study or must abandon it due to health complications, the team member with the number information will be informed, and data will be disregarded from the analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2-arm pragmatic and superiority randomized controlled trial with an intervention and an active control group, with a 1:1 allocation ratio. Participants in this group will perform a home-based combined exercise program throughout their chemotherapy treatments, starting within 1-2 weeks of its start and ending within 3-4 weeks post-treatment completion. Women randomized to the control group will receive weekly 30-minute supervised sessions with breathing, stretching, relaxation exercises, and meditation during the intervention period.

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 24, 2024
• Study Start: November 10, 2024
• Primary Completion: November 20, 2024
• Study Completion: October 10, 2025
• Last Updated: June 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Dissemination policy This trial's findings will be disseminated through publication in leading international oncology scientific journals and presentations at national and international conferences. In addition. the results and mediation analysis will be produced and published. As this is a pragmatic trial with highly applicable outcomes for participants and decision-makers, it presents potential for future widespread implementation through relevant stakeholders.
• Access Criteria: The corresponding author will make anonymized trial data available for non-commercial research purposes upon reasonable request.

Locations

PT (1)