Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors

NCT05473026 | Completed Results DMC

• 2 other identifiers: IRB202201483P30AG028740
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will assess the feasibility of a gratitude intervention to promote physical activity, and well-being and positively impact biomarkers of health among older African American breast cancer survivors. The intervention will also include a goal-setting component to promote exercise readiness and examine the cultural phenomena of the Superwoman schema among Black women.

Conditions

Cancer Survivors; African Americans; Women; Psychology, Positive; Cardiometabolic Syndrome; Exercise; Feasibility Studies; Breast Neoplasm Female

Keywords

African American Women; Breast Cancer Survivorship; Gratitude; Cardiometabolic Syndrome; Geriatrics; Physical Activity

Outcome Measures

Primary Outcomes (4)

• Participants Who Met Inclusion Criteria Compared to Participants Approached

  Percentage of women who meet the inclusion criteria relative to the number of women approached.

  8 months

• Participant Completion of Baseline Assessment Measures

  Percentage of participants completing baseline assessment measures.

  Week 0

• Participant Completion of Both Baseline Assessments and Post-intervention Assessments

  Percentage of participants who completed baseline assessments and completed the post-intervention assessments.

  Week 0, Week 8

• Treatment Satisfaction Using Client Satisfaction Questionnaire (CSQ-8)

  We assessed treatment satisfaction using the mean Client Satisfaction Questionnaire(CSQ-8) scores. An overall score is calculated by summing the respondent's rating score for each scale item. Scores range from 8 to 32, with higher values indicating higher satisfaction.

  Week 8

Secondary Outcomes (7)

• Change in Dispositional Gratitude From Baseline to Post-intervention

  Week 0, Week 8

• Change in Spiritual Well-being From Baseline to Post-intervention

  Week 0, Week 8

• Change in Distress From Baseline to Post-intervention

  Week 0, Week 8

• Change in Superwoman Schema (Racial and Gender Identity) From Baseline to Post-intervention

  Week 0, Week 8

• Change in Exercise Readiness From Baseline to Post-intervention

  Week 0, Week 8

Study Arms (2)

Gratitude Intervention

EXPERIMENTAL

Each participant will receive a gratitude journal (paperback or electronic journal based on preference) for eight weeks and will have the following journaling prompt to complete at least twice a week: "There are many things in our lives, both large and small, that we might be grateful about. Think back over the day and write down on the line below all that you are grateful for today" (maximum six reasons). The educational goal-setting component will be drawn from the American Cancer Society's Nutrition, Physical Activity, and Cancer toolkit. Participants will be able to choose the order in which they complete the goal-setting modules. Both exercises will be administered daily over eight weeks.

Behavioral: Gratitude Intervention

Attention Control

NO INTERVENTION

Each participant will receive a journal (paperback or electronic journal based on preference) Participants will receive the following general journaling prompt to complete at least twice a week: "What are some memorable events that happened to you today, big, or small (maximum six memories). Write a brief statement about it.

Interventions

Gratitude Intervention BEHAVIORAL

Gratitude journaling and goal setting for exercise readiness over eight weeks.

Gratitude Intervention

Eligibility Criteria

• Age: 50 Years - 99 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-report as AA or Black
• English speaking
• History of BC (Stage I-IV); 3 months to 6 years post-adjuvant chemotherapy
• Participants on hormonal therapies or HER-2 therapy are acceptable

You may not qualify if:

• Self-reported regular meditation or gratitude practices (more than once a week for at least a month)
• Meeting the CDC's physical activity guidelines (at least 150 min of moderate-intensity aerobic physical activity or 75 min of vigorous-intensity physical activity, or an equivalent combination each week)

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Florida CTSI Clinical Research Center

Gainesville, Florida, 32603, United States

Location

Related Publications (2)

• Cousin L, Braithwaite D, Anton S, Zhang Z, Lee JH, Leewenburgh C, Lyon D. A pilot study of a gratitude journaling intervention to enhance spiritual well-being and exercise self-efficacy in Black breast cancer survivors. BMC Psychiatry. 2024 Dec 18;24(1):931. doi: 10.1186/s12888-024-06362-2.

  PMID: 39696111 DERIVED

• Cousin L. Cardio-oncology disparities: Interplay of psychosocial stress, inflammation, and cardiometabolic health among Black breast cancer survivors. Am Heart J Plus. 2024 Jan 30;38:100366. doi: 10.1016/j.ahjo.2024.100366. eCollection 2024 Feb.

  PMID: 38510748 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Results Point of Contact

• Title: Lakeshia Cousin, PhD, APRN, AGPCNP-BC
• Organization: University of Florida

lakeshiacousin@ufl.edu

352-273-6318

Study Officials

• Lakeshia Cousin, PhD, APRN

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The principal investigator will inform participants of their group assignment and provide intervention details. The research assistant and biostatistician will be blind to group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-group parallel random-assignment experimental design.

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 25, 2022
• Study Start: November 8, 2022
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)