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

Primary Purpose

Physical Inactivity, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
My Body, My Rhythm, My Voice
Sponsored by
Olga Lucia Sarmiento
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Physical Inactivity focused on measuring Breast cancer survivors, Physical activity, Behavior change intervention, Community-based program, Mixed-methods assessment, Middle-income setting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • School of Medicine, Universidad de los Andes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

My Body, My Rhythm, My Voice

No intervention

Outcomes

Primary Outcome Measures

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.
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).
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).
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.

Secondary Outcome Measures

Sociodemographic variables
To characterize the population, we collected surveys inquiring about sociodemographic variables (i.e., age, education, socioeconomic level, employment status, healthcare access).
Body mass index
Anthropometric data (height, weight) were directly measured by trained interviewers according to standardized procedures using scale and stadiometer. Body mass index (BMI) was calculated using the formula weight (kg)/height2 (m2); and classified according to the World Health Organization BMI classification

Full Information

First Posted
December 7, 2021
Last Updated
February 13, 2022
Sponsor
Olga Lucia Sarmiento
Collaborators
Stanford University, Universidad Manuela Beltrán, Pontificia Universidad Javeriana, Hospital de San Jose, University of California, Los Angeles, National Institutes of Health (NIH), National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05252780
Brief Title
A Community Dance Intervention Engaging Breast Cancer Survivors in a Middle-income Country
Official Title
"My Body, My Rhythm, My Voice": a Community Dance Intervention Engaging Breast Cancer Survivors in Physical Activity in a Middle-income Country
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Olga Lucia Sarmiento
Collaborators
Stanford University, Universidad Manuela Beltrán, Pontificia Universidad Javeriana, Hospital de San Jose, University of California, Los Angeles, National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a quasi-experimental study with a control group and an intervention group. The study population are patients over 18 years of age with a diagnosis of breast cancer who have received management and are currently in remission phase (more than 1 year after finishing management with chemotherapy and radiotherapy) and who do not report having any medical contraindication for the practice of physical activity (angina, acute myocardial infarction, pulmonary embolism, arterial hypertension and uncontrolled diabetes mellitus, severe lymphedema). The control group will be patients who attend their medical check-ups at the National Cancer Institute of Colombia and the intervention group will be patients who are cared for by units of the Bogotá's medical service. It will have the written approval of the ethics committee of the respective hospitals. Being an exploratory study that investigates the acceptability and main motivations for attending physical activity sessions on a regular basis, it is considered that a sample of 30 people in the control group and 30 people in the intervention group could provide the necessary information to have in mind to develop studies with more significant sample sizes in the future. For 8 weeks the intervention group will be offered 24 classes of musicalized directed physical activity (through a training protocol adapted for patients with this underlying pathology), and 8 craft workshops, to be held in the same space as the physical activity sessions. Additionally, at the same time, healthy habits will be promoted with the control group through text messages during 8 weeks, with a two workshops (at the beginning and the end of this period). The classes and workshops will be held at the facilities of the health provider institution in a place that guarantees the privacy of the participants. For the recruitment of patients in the intervention group, women who were diagnosed with altered BI-RADS will be contacted by telephone. For the recruitment of patients from the control group, the head nurse who coordinates the follow-up program for breast cancer patients will be asked to invite the women in the study to participate. Additionally, all invited patients will receive the information through an attached information sheet. Before the start of the intervention and after it, the following measurements will be made: The questionnaires include questions about sociodemographic data, medical information, quality of life, general state of health, optimism and pessimism about life, anxiety and depression, perception of fatigue, knowledge about physical activity, self-efficacy in physical activity and social support for the practice of physical activity. These questionnaires will be administered by pollsters trained and registered through the Qualtrics application. These questionnaires will be applied by trained interviewers in a personal meeting in both health centers, in a space that ensures the confidentiality and security of the information. Objective measurements that include levels of physical activity by accelerometry and body composition by bio-impedance. These measurements will be carried out by a professional in Respiratory Therapy in the facilities of the institution that provides services where the women have been recruited, as appropriate control group or intervention group. The research team will provide the transportation service to take the participants to the facilities. To guarantee the physical safety of the people who participate, there will be a person certified in life support, who will ensure that the participant who requires entering in the most efficient way to the health system. It is worth clarifying that all study participants will have affiliation to a Health Promoting Entity through which they attend their oncology controls, and additionally, the research group will have a medical insurance policy for the patients who participate in the intervention to cover any event that may arise during it. Collection of qualitative information through focus groups led by an anthropology professional to explore what breast cancer survivors look for in a physical activity program and the main motivations and barriers to attending said program and its acceptability. In addition, information will be collected through interviews with experts who work in health promotion, disease prevention, and cancer patient management to identify those factors that are important to be able to articulate the recreation sector with the health sector in the implementation of a targeted physical activity program for breast cancer survivors. Approximately 10 to 15 interviews will be carried out according to the saturation of the information; the recruitment of these experts will be done through snowball sampling where an expert will refer to contacts related to this topic. Statistical analyzes will be carried out with SPSS and SAS, an ANOVA analysis of variance, Kruskal-Wallis and McNemar's tests of repeated measures will be carried out to establish the change in the results before and after the intervention. To support the analysis of qualitative data from both the focus groups and the interviews, the NVIVO12 software will be used. Participants will receive the aggregated results of the general study ensuring confidentiality. Additionally, the participants will receive individually the results of the anthropometric tests and stress tests so that they know their physical condition; those who find a level of risk of coronary heart disease will be explicitly suggested to consult a specialist doctor through their insurer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Inactivity, Breast Cancer
Keywords
Breast cancer survivors, Physical activity, Behavior change intervention, Community-based program, Mixed-methods assessment, Middle-income setting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
My Body, My Rhythm, My Voice
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
My Body, My Rhythm, My Voice
Other Intervention Name(s)
My Body
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in participants' physical activity levels
Description
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.
Time Frame
Physical activity levels were assessed at baseline and after the 8th week
Title
Change in participants' motivation to engage in physical activity
Description
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).
Time Frame
Motivational regulation for physical activity was assessed at baseline and after the 8th week
Title
Change in participants' quality of life
Description
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).
Time Frame
Quality of life was assessed at baseline and after the 8th week
Title
Acceptability of My Body
Description
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.
Time Frame
Semi-structured interviews were conducted after the 8th week
Secondary Outcome Measure Information:
Title
Sociodemographic variables
Description
To characterize the population, we collected surveys inquiring about sociodemographic variables (i.e., age, education, socioeconomic level, employment status, healthcare access).
Time Frame
Surveys were collected at the baseline
Title
Body mass index
Description
Anthropometric data (height, weight) were directly measured by trained interviewers according to standardized procedures using scale and stadiometer. Body mass index (BMI) was calculated using the formula weight (kg)/height2 (m2); and classified according to the World Health Organization BMI classification
Time Frame
BMI was assessed at the baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: The presence of metastatic disease and other health conditions for which community physical activity was contraindicated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga Lucía Sarmiento, PhD
Organizational Affiliation
Department of Public Health, School of Medicine, Universidad de los Andes, Bogotá, Colombia
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Medicine, Universidad de los Andes
City
Bogotá
ZIP/Postal Code
111711
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
No
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A Community Dance Intervention Engaging Breast Cancer Survivors in a Middle-income Country

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