Overview

This trial is active, not recruiting.

Conditions cancer survivor, stage ia breast cancer, stage ib breast cancer, stage iia breast cancer, stage iib breast cancer, stage iiia breast cancer, stage iiib breast cancer, stage iiic breast cancer
Treatments one-on-one interview, survey questions
Sponsor Case Comprehensive Cancer Center
Collaborator National Institute on Minority Health and Health Disparities (NIMHD)
Start date October 2015
End date December 2016
Trial size 61 participants
Trial identifier NCT02566408, CASE 5115, CASE5115, NCI-2015-01052

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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.
one-on-one interview
Undergo one-on-one interview about KAPs towards PA
survey questions
Complete survey

Primary Outcomes

Measure
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
Qualitative analysis of in-depth interviews to identify attitudes towards physical activity.
time frame: 6 months
Qualitative analysis of in-depth interviews to identify attitudes towards the physical activity program.
time frame: 6 months

Eligibility Criteria

Female participants at least 65 years old.

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

Additional Information

Official title Attitudes, Beliefs and Preferences of Older Breast Cancer Survivors Towards Physical Activity
Principal investigator Cynthia Owusu
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Case Comprehensive Cancer Center.