Nurse-led Physical Activity Program Among Breast Cancer Survivors

NCT06248918 | Enrolling By Invitation

• 1 other identifier: IMUH-HEM-SK-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

A nurse-led physical activity program including an individualized exercise program using wearable technology and health coaching based on Social Cognitive Theory will be implemented for women surviving cancer. The impact of the nurse-led physical activity program on physical activity level, health-related quality of life and cognitive factors (self regulation, outcome expectation, self efficacy, perceived social support, perceived environment) will be evaluated in the study.

Conditions

Breast Cancer Female; Survivorship; Health Behavior

Keywords

Breast Cancer; Survivors; Physical Activity; Social Cognitive Theory; Health-Related Quality Of Life

Outcome Measures

Primary Outcomes (1)

• Self Reported Physical Activity

  Change in physical activity, as measured by the "International Physical Activity Questionnaire-Short Form", from baseline to 12 and 24 weeks. Participants report frequency of light, moderate and vigorous physical activity, and average duration (minutes/week) bouts for 10 minutes or longer in the last seven days. Scores for light, moderate and vigorous exercise are combined to compute total physical activity minutes/week. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities. Standard MET (metabolic equivalent) values for activities were established. The 'MET-min/week' value is obtained by multiplying the MET value of each physical activity level with the days and minutes this physical activity is performed every week. The obtained MET value is classified as HEPA active (MET\>3000), minimally active (MET=600-3000), and inactive (MET\<600).

  Baseline, 12 weeks, 24 weeks

Secondary Outcomes (9)

• Health Related Quality of Life: EORTC-QLQ-C30

  Baseline, 12 weeks, 24 weeks

• Health Related Quality of Life-Breast Cancer Specified: EORTC-QLQ-BR23

  Baseline, 12 weeks, 24 weeks

• BMI

  Baseline, 12 weeks, 24 weeks

• Fatigue

  Baseline, 12 weeks, 24 weeks

• Self-efficacy For Exercise

  Baseline, 12 weeks, 24 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants will receive an exercise plan, activity tracker, and physical activity coaching program based Social Cognitive Theory.

Behavioral: WATSOCPAP

Control Group

NO INTERVENTION

The control group will not take any intervention but take a standard care, the post-tests will be collected at the end of 12 weeks.

Interventions

WATSOCPAP BEHAVIORAL

Participants will receive an supervised and individualized exercise plan, activity tracker, and physical activity coaching program based Social Cognitive Theory. Participants will be administered strengthening and aerobic exercise program, structured and individualized according to the person's individual capacity and needs, under the supervision of a physiotherapist. The activity tracker will provide real-time activity information about daily steps, time spent with MVPA (minutes/day) and sedentary time. The nurse-led physical activity coaching program was planned according to the Social Cognitive Theory (SCT) components such as self-regulation, outcome expectation, social support and perceived environment. The interventions will continue with online and the 12-week program will be completed.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18-65
• Female gender
• Diagnosed with stage I-III breast cancer survivors,
• Completed active cancer primary treatment (surgery, chemotherapy, and/or radiotherapy) in the previous 5 years, excluding hormone therapy,
• No evidence of recurrence,
• No contraindications,
• Less than 150 minutes of moderate-intensity physical activity or 75 minutes of vigorous-intensity physical activity per week,
• Having a smart mobile phone and to access and use the internet,
• Live in Istanbul city,
• No medical condition(s) that non-adherence to an exercise program

You may not qualify if:

• Currently pregnant or planning to become pregnant during the study period,
• Musculoskeletal, neurological, respiratory, metabolic or cardiovascular health problems which preclude exercise,
• Cancer recurrence and resumption of active cancer treatment.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Health Behavior; Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Sura Kaya, MSc

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year
• Access Criteria: Individual participants data that underlie the results reported in this article, after de identification (text, tables, figures, appendices).

Locations

TU (1)