Attitudes, Beliefs, and Preferences of Older Stage I-III Breast Cancer Survivors Towards Physical Activity

January 2, 2020 updated by: Case Comprehensive Cancer Center

Attitudes, Beliefs and Preferences of Older Breast Cancer Survivors Towards Physical Activity

This clinical trial studies the attitudes, beliefs, and preferences of older stage I-III breast cancer survivors towards physical activity. Studies have shown that older African-American and women of lower socioeconomic status are more likely than their Caucasian counterparts and women of higher socioeconomic status to have functional disability at the time of a new breast cancer diagnosis. Functional disability is the inability to independently complete activities of daily living and increases health care costs and deaths. The poor health status of older African-Americans with breast cancer has been suggested to diminish the long-term benefits from cancer treatment, resulting in older African-American women more likely to die from breast cancer compared to Caucasians. Questionnaires that measure the attitudes, beliefs, and preferences of older breast cancer survivors may lead to the development of an intervention that increases physical activity, improves functional and health status, and improves breast cancer treatment benefits translating to improved survival among older breast cancer survivors in general, and in particular among older African-American and lower socioeconomic status women with breast cancer.

Study Overview

Detailed Description

PRIMARY OBJECTIVES:

I. To assess physical activity beliefs, attitudes and preferences (KAPs) of breast cancer (BCa) survivors to inform the development of a physical activity (PA) intervention that will foster initial enrollment and sustained participation, particularly for African American (AA) and socioeconomic status (SES)-disadvantaged BCa survivors.

OUTLINE:

INTERVIEWS AND GROUP DISCUSSION: Participants undergo a 2-hour one-on-one interview about their KAPs towards PA. Ten topics will be used to explore older women's attitudes toward PA: (a) terminology used to describe PA; (b) meaning of PA to older women; (c) usual PA during daily life; (d) perceived influences and benefits of PA on body and mind; (e) recent changes in PA and their influences on women's daily life; (f) facilitators and barriers to older women's participation in PA; (g) preferences for PA in general and specific types of PA; (h) age-related differences in attitudes toward PA; (i) ethnic differences in attitudes toward PA; (i) SES-related differences in attitudes toward PA; and (j) overall feeling about PA. Six topics will also be used to explore ethnic-specific and culture-specific contexts that surround older women's participation in PA: (a) older women's daily life schedules, and hardships and sufferings in daily lives; (b) culturally unique aspects of women's daily lives; (c) age-related difficulties and advantages in daily lives influencing older women's participation in PA; (d) ethnicity-related, cultural-related and SES-related difficulties and advantages in daily lives influencing women's participation in PA; (f) culturally available support for PA and women's preferences for support; and (g) older women's preferences for PA promotion programs.

REFINEMENT OF THE PA INTERVENTION: Approximately 1-2 months after the conclusion of interviews, participants are invited to a joint session and presented with results of analyzed data. Participants are asked to review results and themes identified from interviews, and to concur whether conclusions capture their KAPs. Through this process a set of preferences that is agreed upon by all as most critical for enhancing PA participation, adherence, and retention will be identified.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pathologically confirmed breast cancer
  • Stage I-III
  • Patients who have completed treatment for breast cancer and are within two years of treatment completion (primary surgery, chemotherapy or radiation therapy), whichever was received last; hormonal therapy and targeted therapies in the adjuvant setting are allowed
  • African-Americans and non-Hispanic Whites

Exclusion Criteria:

  • Stage IV breast cancer
  • Patients with end-stage disease, severe dementia and/or life expectancy of less than one year
  • Inability to understand English
  • Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive Care (interview about KAPs towards PA)

Participants undergo a 2-hour one-on-one interview and answer survey questions about their beliefs, attitudes, and preferences (KAPs) towards physical activity (PA). Ten topics will be used to explore older women's attitudes toward PA. Six topics will also be used to explore ethnic-specific and culture-specific contexts that surround older women's participation in PA.

REFINEMENT OF THE PA INTERVENTION: Approximately 1-2 months after the conclusion of interviews, participants are invited to a joint session and presented with results of analyzed data. Participants are asked to review results and themes identified from interviews, and to concur whether conclusions capture their KAPs. Through this process a set of preferences that is agreed upon by all as most critical for enhancing PA participation, adherence, and retention will be identified.

Undergo one-on-one interview about KAPs towards PA
Complete survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative analysis of in-depth interviews to identify features which foster initial enrollment of African Americans and Socioeconomic Status disadvantaged breast cancer survivors in breast cancer studies
Time Frame: 6 months
Features of the physical activity program that are important to the initial enrollment of older breast cancer survivors, particularly African American and Socioeconomic Status disadvantaged breast cancer survivors. These features will be analyzed using descriptive statistics. Examining the data by groups will further refine understanding of the emergent themes. Discussion of the findings and suggestions for interpretation will be used to guide subsequent analyses to more fully understand the themes and patterns among the themes.
6 months
Qualitative analysis of in-depth interviews to identify attitudes towards physical activity.
Time Frame: 6 months
Identification of attitudes of survivors toward physical activity will be analyzed using descriptive statistics. Examining the data by groups will further refine understanding of the emergent themes. Discussion of the findings and suggestions for interpretation will be used to guide subsequent analyses to more fully understand the themes and patterns among the themes.
6 months
Qualitative analysis of in-depth interviews to identify attitudes towards the physical activity program.
Time Frame: 6 months
Identification of attitudes of survivors toward the physical activity program will be analyzed using descriptive statistics. Examining the data by groups will further refine understanding of the emergent themes. Discussion of the findings and suggestions for interpretation will be used to guide subsequent analyses to more fully understand the themes and patterns among the themes.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Cynthia Owusu, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

September 29, 2015

First Submitted That Met QC Criteria

September 30, 2015

First Posted (Estimate)

October 2, 2015

Study Record Updates

Last Update Posted (Actual)

January 3, 2020

Last Update Submitted That Met QC Criteria

January 2, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • CASE5115
  • NCI-2015-01052 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CASE 5115 (Other Identifier: Case Comprehensive Cancer Center)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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