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

Primary Purpose

Cancer Survivors, African Americans, Women

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gratitude Intervention
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer Survivors focused on measuring African American Women, Breast Cancer Survivorship, Gratitude, Cardiometabolic Syndrome, Geriatrics, Physical Activity

Eligibility Criteria

50 Years - 99 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Florida CTSI Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Gratitude Intervention

Attention Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Participants who met inclusion criteria compared to participants approached
Percentage of women who meet the inclusion criteria relative to the number of women approached.
Participant completion of baseline assessment measures
Percentage of participants completing baseline assessment measures.
Participant completion of both baseline assessments and post-intervention assessments
Percentage of participants who completed baseline assessments and completed the post-intervention assessments.
Treatment satisfaction using Client Satisfaction Questionnaire (CSQ-8)
We will assess 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.

Secondary Outcome Measures

Change in dispositional gratitude from baseline to post-intervention
The effect size of dispositional gratitude measured at week 0/baseline and post-intervention/week 8 will be measured using the Gratitude Questionnaire-6 designed to measure four facets of dispositional gratitude: (a) intensity, (b) frequency, (c) span, and (d) density. Each item is rated on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher scores mean higher dispositional gratitude.
Change in spiritual well-being from baseline to post-intervention
The effect size of spiritual well-being baseline/week 0 and post-intervention/week 8 will be measured using the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale designed to assess spiritual well-being over the past seven days in a population with a chronic illness. Items are rated on a Likert-type scale ranging from 0 (not at all) to 4 (very much). Higher scores indicate enhanced spiritual well-being.
Change in Distress from baseline to post-intervention
The effect size of distress baseline/week 0 and post-intervention/week 8 will be measured using the Perceived Stress Scale designed to measure stress during the last month. The scale consists of 10 items rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often) during the last month. Higher scores indicate more distress during the last month.
Change in Superwoman schema (racial and gender identity) from baseline to post-intervention
The effect size of the Superwoman schema baseline/week 0 and post-intervention/week 8 will be measured using the Giscombe Superwoman Schema Questionnaire developed to measure components prominent in the superwoman schema construct. The Giscombe Superwoman Schema Questionnaire (G-SWS-Q) was developed to measure components prominent in the superwoman schema construct. It contains 35 statements rated from 0 (not true) to 4 (true all the time) across the 5 subscales of (1) obligation to present an image of strength, (2) obligation to suppress emotions, (3) resistance to being vulnerable, (4) intense motivation to succeed and (5) obligation to help others. Higher scores indicate higher agreement with the identity.
Change in Exercise readiness from baseline to post-intervention
The effect size of exercise readiness baseline/week 0 and post-intervention/week 8 will be measured using the Stage of Motivational Readiness for Physical Activity questionnaire, a highly reliable instrument with items that classify a person as being in the pre-contemplation, contemplation, preparation, action, or maintenance stage of exercise behavior change based on the selection by the participant.
Change in Inflammatory biomarkers from baseline to post-intervention
The effect size of inflammatory biomarkers baseline/week 0 and post-intervention/week 8 will be measured using a Luminex panel containing Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6), Growth/Differentiation Factor-15 (GDF15), and Enzyme-linked immunosorbent assay (ELISA) kit containing C-Reactive Protein.

Full Information

First Posted
July 13, 2022
Last Updated
July 25, 2023
Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05473026
Brief Title
Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors
Official Title
A Pilot Feasibility Study of a Gratitude Journaling Intervention to Enhance Well-being and Exercise Readiness in Older African American Female Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 8, 2022 (Actual)
Primary Completion Date
July 25, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA)

4. Oversight

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

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-group parallel random-assignment experimental design.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gratitude Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Gratitude Intervention
Intervention Description
Gratitude journaling and goal setting for exercise readiness over eight weeks.
Primary Outcome Measure Information:
Title
Participants who met inclusion criteria compared to participants approached
Description
Percentage of women who meet the inclusion criteria relative to the number of women approached.
Time Frame
8 months
Title
Participant completion of baseline assessment measures
Description
Percentage of participants completing baseline assessment measures.
Time Frame
Week 0
Title
Participant completion of both baseline assessments and post-intervention assessments
Description
Percentage of participants who completed baseline assessments and completed the post-intervention assessments.
Time Frame
Week 0, Week 8
Title
Treatment satisfaction using Client Satisfaction Questionnaire (CSQ-8)
Description
We will assess 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.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Change in dispositional gratitude from baseline to post-intervention
Description
The effect size of dispositional gratitude measured at week 0/baseline and post-intervention/week 8 will be measured using the Gratitude Questionnaire-6 designed to measure four facets of dispositional gratitude: (a) intensity, (b) frequency, (c) span, and (d) density. Each item is rated on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher scores mean higher dispositional gratitude.
Time Frame
Week 0, Week 8
Title
Change in spiritual well-being from baseline to post-intervention
Description
The effect size of spiritual well-being baseline/week 0 and post-intervention/week 8 will be measured using the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale designed to assess spiritual well-being over the past seven days in a population with a chronic illness. Items are rated on a Likert-type scale ranging from 0 (not at all) to 4 (very much). Higher scores indicate enhanced spiritual well-being.
Time Frame
Week 0, Week 8
Title
Change in Distress from baseline to post-intervention
Description
The effect size of distress baseline/week 0 and post-intervention/week 8 will be measured using the Perceived Stress Scale designed to measure stress during the last month. The scale consists of 10 items rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often) during the last month. Higher scores indicate more distress during the last month.
Time Frame
Week 0, Week 8
Title
Change in Superwoman schema (racial and gender identity) from baseline to post-intervention
Description
The effect size of the Superwoman schema baseline/week 0 and post-intervention/week 8 will be measured using the Giscombe Superwoman Schema Questionnaire developed to measure components prominent in the superwoman schema construct. The Giscombe Superwoman Schema Questionnaire (G-SWS-Q) was developed to measure components prominent in the superwoman schema construct. It contains 35 statements rated from 0 (not true) to 4 (true all the time) across the 5 subscales of (1) obligation to present an image of strength, (2) obligation to suppress emotions, (3) resistance to being vulnerable, (4) intense motivation to succeed and (5) obligation to help others. Higher scores indicate higher agreement with the identity.
Time Frame
Week 0, Week 8
Title
Change in Exercise readiness from baseline to post-intervention
Description
The effect size of exercise readiness baseline/week 0 and post-intervention/week 8 will be measured using the Stage of Motivational Readiness for Physical Activity questionnaire, a highly reliable instrument with items that classify a person as being in the pre-contemplation, contemplation, preparation, action, or maintenance stage of exercise behavior change based on the selection by the participant.
Time Frame
Week 0, Week 8
Title
Change in Inflammatory biomarkers from baseline to post-intervention
Description
The effect size of inflammatory biomarkers baseline/week 0 and post-intervention/week 8 will be measured using a Luminex panel containing Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6), Growth/Differentiation Factor-15 (GDF15), and Enzyme-linked immunosorbent assay (ELISA) kit containing C-Reactive Protein.
Time Frame
Week 0, Week 8

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lakeshia Cousin, PhD, APRN
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida CTSI Clinical Research Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32603
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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