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

Sponsor

University of Florida (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05473026

Collaborator

National Institute on Aging (NIA) (NIH)

Enrollment

Arms

5.9

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Survivors African Americans Women Psychology, Positive Cardiometabolic Syndrome Exercise Feasibility Studies Breast Neoplasm Female	Behavioral: Gratitude Intervention	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two-group parallel random-assignment experimental design.Two-group parallel random-assignment experimental design.

Masking:

Single (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.

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Gratitude Intervention Gratitude journaling and goal setting for exercise readiness over eight weeks.
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: Gratitude Intervention

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

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Participants who met inclusion criteria compared to participants approached [8 months]
Percentage of women who meet the inclusion criteria relative to the number of women approached.
Participant completion of baseline assessment measures [Week 0]
Percentage of participants completing baseline assessment measures.
Participant completion of both baseline assessments and post-intervention assessments [Week 0, Week 8]
Percentage of participants who completed baseline assessments and completed the post-intervention assessments.
Treatment satisfaction using Client Satisfaction Questionnaire (CSQ-8) [Week 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 [Week 0, Week 8]
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 [Week 0, Week 8]
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 [Week 0, Week 8]
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 [Week 0, Week 8]
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 [Week 0, Week 8]
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 [Week 0, Week 8]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 99 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)