A Community Dance Intervention Engaging Breast Cancer Survivors in a Middle-income Country

NCT05252780 | Completed

• 2 other identifiers: P20CA217199-9492018P20CA217199
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Interventions to promote physical activity among women breast cancer survivors (BCS) in low to middle-income countries are limited. We conducted a study to assess the acceptability and preliminary effectiveness of an 8-week, 3 times/week group dance intervention for BCS delivered in Bogotá, Colombia. The effect of the intervention on participants' physical activity levels, motivation to engage in physical activity, and quality of life were evaluated, and interviews were thematically analyzed to assess program acceptability.

Conditions

Physical Inactivity; Breast Cancer

Keywords

Breast cancer survivors; Physical activity; Behavior change intervention; Community-based program; Mixed-methods assessment; Middle-income setting

Outcome Measures

Primary Outcomes (4)

• Change in participants' physical activity levels

  To assess the change from baseline participants' physical activity levels at 8 weeks, participants wore accelerometers for 7 consecutive days from awakening to bedtime using an elasticized belt around the waist at the right mid-axillary line. For wear-time validation, a minimum of four weekdays and a weekend day with at least 10 hours of wear during the waking time was required. Accelerometers were initialized to collect data at a sampling frequency of 80 Hz, downloaded in one-second epochs and grouped in 60-second epochs for analysis.

  Physical activity levels were assessed at baseline and after the 8th week

• Change in participants' motivation to engage in physical activity

  To assess the change from baseline participants´ motivational regulation for physical activity at 8 weeks, we used the validated Spanish version of the Behavioral Regulation in Exercise Questionnaire-3 \[BREQ-3\], a 23-item inventory assessing the Self-Determination Theory relevant constructs (which conceptualizes motivation as a continuum ranging from amotivation to a high level of intrinsic motivation). Responses to each item were reported on a 5-point scale ranging from 0 (not true for me) to 4 (very true for me).

  Motivational regulation for physical activity was assessed at baseline and after the 8th week

• Change in participants' quality of life

  To assess the change of quality of life, we used the official Colombian Spanish translation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. It incorporates five functioning subscales, three symptom subscales, six single symptoms, an item for illness-related financial difficulties, and a two-item general health/global QoL subscale. Each item was reported on a 4-point scale ranging from 1 (not at all) to 4 (very much), except for the general health subscale, which response options range from 1 (very poor) to 7 (excellent). High scores on the functioning subscales and the global health status/QoL subscale represent higher quality of life, while high scores on the symptom subscales indicate high levels of symptomatology. We also used a subscale of the EORTC questionnaire specific to breast cancer patients regarding physical symptoms for lymphedema; it comprises seven items with responses also ranging from 1 (not at all) to 4 (very much).

  Quality of life was assessed at baseline and after the 8th week

• Acceptability of My Body

  We used a semi-structured interviewing technique to ensure in-depth insights about BCS' perspectives towards physical activity, their anticipated and actual experienced barriers and facilitators to engage in the physical activity intervention, their expected and reported benefits from the physical activity intervention, and the perceived positive and negative aspects of the program.

  Semi-structured interviews were conducted after the 8th week

Secondary Outcomes (2)

• Sociodemographic variables

  Surveys were collected at the baseline

• Body mass index

  BMI was assessed at the baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

My Body, My Rhythm, My Voice

Behavioral: My Body, My Rhythm, My Voice

Control group

NO INTERVENTION

No intervention

Interventions

My Body, My Rhythm, My Voice BEHAVIORAL

My Body was a behavioral intervention informed by the social cognitive and self-determination theories. Based on the discussions and a systematic review of the literature, we designed the 8-week, 3 times/week rumba physical activity intervention. The goal of the intervention was to gradually increase all participants' physical activity levels to achieve significant health benefits. As part of the physical activity intervention, participants were also taught by their instructor during each class how to utilize behavioral and cognitive self-regulatory skills to increase and maintain their physical activity participation. Examples of such skills were action planning, coping planning, counter conditioning, self-evaluation, among others.

Also known as: My Body

Intervention group

Eligibility Criteria

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

You may qualify if:

• BCS at least six months post treatment completion
• More than 18 years of age
• Living in Bogotá
• Willing to attend the program and the assessments

You may not qualify if:

• The presence of metastatic disease and other health conditions for which community physical activity was contraindicated

Sponsors & Collaborators

• Olga Lucia Sarmiento: lead
• Stanford University: collaborator
• Universidad Manuela Beltrán: collaborator
• Pontificia Universidad Javeriana: collaborator
• Hospital de San Jose: collaborator
• University of California, Los Angeles: collaborator
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

School of Medicine, Universidad de los Andes

Bogotá, 111711, Colombia

Location

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MeSH Terms

Conditions

Sedentary Behavior; Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Olga Lucía Sarmiento, PhD

  Department of Public Health, School of Medicine, Universidad de los Andes, Bogotá, Colombia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor School of Medicine, Epidemiology, Universidad de los Andes, Bogota, Colombia

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: February 23, 2022
• Study Start: March 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: August 31, 2020
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)