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

NCT ID: NCT05473026

Last Updated: 2024-09-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-08

Study Completion Date

2023-07-25

Brief Summary

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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.

Detailed Description

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In this pilot feasibility study, the overall aims are:

Aim 1. Assess the feasibility and acceptability of a gratitude journaling intervention using a pilot randomized controlled trial (RCT) design over eight weeks. We hypothesize that among the 28 participants 1) at least 80% of the participants will report the intervention to be acceptable, 2) biomarker collection will be completed in at least 80% of the surveys and the retention rate will be 80% in each group, and 3) physical activity, health markers, gratitude, well-being, and distress will improve over time.

Aim 2. Describe distributions of outcome variables and effect size for the gratitude journaling intervention on dispositional gratitude, spiritual well-being, psychological distress, exercise readiness, mental and health behaviors in African American/Black women (Superwoman Schema), and inflammatory biomarkers from baseline to post-intervention.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-group parallel random-assignment experimental design.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Gratitude Intervention

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.

Group Type EXPERIMENTAL

Gratitude Intervention

Intervention Type BEHAVIORAL

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

Attention Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Gratitude Intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lakeshia Cousin, PhD, APRN

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida CTSI Clinical Research Center

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39696111 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38510748 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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P30AG028740

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB202201483

Identifier Type: -

Identifier Source: org_study_id

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