Cancer SurvivorsNCT05473026
Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors
A study testing Gratitude Intervention in people with Cancer Survivors and African Americans, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer Survivors, African Americans, Women
- What is being tested?
- Gratitude Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2022to 25 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida CTSI Clinical Research Center
Gainesville, Florida, 32603
About this study
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
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.
Read the 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.
- Conditions
- Cancer Survivors, African Americans, Women, Psychology, Positive, Cardiometabolic Syndrome, Exercise
- Being tested
- Gratitude Intervention
- Keywords
- African American Women, Breast Cancer Survivorship, Gratitude, Cardiometabolic Syndrome, Geriatrics, Physical Activity
- Medical subject headings
- Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gratitude InterventionBehavioural
Gratitude journaling and goal setting for exercise readiness over eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Who Met Inclusion Criteria Compared to Participants Approached
Percentage of women who meet the inclusion criteria relative to the number of women approached.
Measured: 8 months
Participant Completion of Baseline Assessment Measures
Percentage of participants completing baseline assessment measures.
Measured: 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.
Measured: 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.
Measured: Week 8
Secondary outcomes (7)
Change in Dispositional Gratitude From Baseline to Post-intervention
The mean change of dispositional gratitude measured at week 0/baseline and post-intervention/week 8 was measured using the Gratitude Questionnaire-6 designed to measure four facets of dispositional gratitude: (a) intensity, (b) frequency, (c) span, and (d) density. The scale consists of six items, each rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). To calculate the GQ-6 score, each item's score is summed to yield a total score. The minimum possible score is 6, indicating the lowest level of gratitude, and the maximum possible score is 42, indicating the highest level of gratitude. For example, if a participant's responses to the six items are 5 (slightly agree), 6 (agree), 4 (neutral), 7 (strongly agree), 3 (slightly disagree), and 5 (slightly agree), the total score would be 30. This total score is then used to gauge the participant's level of gratitude, with higher scores reflecting greater gratitude.
Measured: Week 0, Week 8
Change in Spiritual Well-being From Baseline to Post-intervention
The Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being is a self-report measure designed to assess spiritual well-being in individuals with chronic illness. It was used to report mean change from week 0/baseline and post-intervention/week 8. The scale comprises 12 items divided into two subscales: Meaning/Peace and Faith. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). To calculate the FACIT-Sp-12 score, each item's score is summed. The Meaning/Peace subscale score is obtained by summing the scores of items 1 to 8, with a range of 0 to 32. The Faith subscale score is derived from items 9 to 12, with a range of 0 to 16. The total spiritual well-being score, which combines both subscales, ranges from 0 to 48. Higher scores on the FACIT-Sp-12 indicate greater spiritual well-being.
Measured: Week 0, Week 8
Change in Distress From Baseline to Post-intervention
The mean change of distress baseline/week 0 and post-intervention/week 8 was measured using the Perceived Stress Scale designed to measure stress during the last month. The scale consists of 10 items, each rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). To calculate the PSS score, each item's score is summed, with items 4, 5, 7, and 8 being reverse-scored to account for their positive phrasing. The reversed scoring for these items means that a response of 0 becomes 4, 1 becomes 3, 2 remains 2, 3 becomes 1, and 4 becomes 0. The total score, ranging from 0 to 40, reflects the individual's perceived stress level, with higher scores indicating greater stress.
Measured: Week 0, Week 8
Change in Superwoman Schema (Racial and Gender Identity) From Baseline to Post-intervention
The Giscombe Superwoman Schema Questionnaire (GSSQ) measured the mean change in Superwoman Schema between baseline and post-intervention at weeks 0 and 8. The GSSQ consists of 35 items across five dimensions: obligation to manifest strength (6 items), obligation to suppress emotions (7 items), resistance to being vulnerable (7 items), intense motivation to succeed (6 items), and obligation to help others (9 items). Items are rated on a Likert scale from 0 (not true) to 3 (true all the time). The total score ranges from 0 to 105, with subscale ranges as follows: Strength (0-18), Suppress (0-21), Resistance (0-21), Motivation (0-18), and Help (0-27). Higher scores indicate stronger endorsement of the Superwoman Schema. Total and subscale scores are summed, with higher scores representing stronger schema identification.
Measured: Week 0, Week 8
Change in Exercise Readiness From Baseline to Post-intervention
The Exercise Readiness Scale measured the stages of exercise behavior change at baseline and post-intervention. The scale consists of five items assessing exercise behavior and intentions. Participants choose one statement that best describes their current level of physical activity, with options ranging from 1 (no participation in physical activity and no intention to start) to 5 (exercising regularly for more than 6 months). Scores range from 1 to 5, with higher scores indicating greater readiness for regular physical activity and higher stages of exercise behavior change.
Measured: Week 0, Week 8
Change in Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6), Growth/Differentiation Factor-15 (GDF15) From Baseline to Post-intervention
The mean change of inflammatory biomarkers baseline/week 0 and post-intervention/week 8 was measured using a Luminex panel containing Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6), Growth/Differentiation Factor-15 (GDF15).
Measured: Week 0, Week 8
Change in C-Reactive Protein From Baseline to Post-intervention
The mean change of inflammatory biomarkers baseline/week 0 and post-intervention/week 8 was measured using a Enzyme-linked immunosorbent assay (ELISA) kit containing C-Reactive Protein.
Measured: Week 0, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start8 Nov 2022
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-group parallel random-assignment experimental design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Lakeshia Cousin, PhD, APRN, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473026
- Sponsor's protocol ID
- IRB202201483
- Other IDs
- P30AG028740
- Status last verified
- Sep 2024
- First submitted
- 13 Jul 2022
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39696111Cousin 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.
PubMed 38510748
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05473026
- Acronym / sponsor ID
- IRB202201483
- Conditions
- Cancer Survivors, African Americans, Women, Psychology, Positive, Cardiometabolic Syndrome, Exercise
- Keywords
- African American Women, Breast Cancer Survivorship, Gratitude, Cardiometabolic Syndrome, Geriatrics, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 25 Jul 2022 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-group parallel random-assignment experimental design.
| Arm | Type | Receives |
|---|---|---|
| Gratitude Intervention | Experimental | Behavioral: Gratitude InterventionEach 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. |
| 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. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gratitude InterventionGratitude journaling and goal setting for exercise readiness over eight weeks. | Behavioural | Gratitude Intervention |
Primary outcome
Participants Who Met Inclusion Criteria Compared to Participants Approached
Time frame: 8 months
Percentage of women who meet the inclusion criteria relative to the number of women approached.
Participant Completion of Baseline Assessment Measures
Time frame: Week 0
Percentage of participants completing baseline assessment measures.
Participant Completion of Both Baseline Assessments and Post-intervention Assessments
Time frame: 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)
Time frame: Week 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.
7 secondary outcomes
Change in Dispositional Gratitude From Baseline to Post-intervention
Time frame: Week 0, Week 8
Change in Spiritual Well-being From Baseline to Post-intervention
Time frame: Week 0, Week 8
Change in Distress From Baseline to Post-intervention
Time frame: Week 0, Week 8
Change in Superwoman Schema (Racial and Gender Identity) From Baseline to Post-intervention
Time frame: Week 0, Week 8
Change in Exercise Readiness From Baseline to Post-intervention
Time frame: Week 0, Week 8
Change in Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6), Growth/Differentiation Factor-15 (GDF15) From Baseline to Post-intervention
Time frame: Week 0, Week 8
Change in C-Reactive Protein From Baseline to Post-intervention
Time frame: Week 0, Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39696111Cousin 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.
- Derived from this study: PubMed 38510748Cousin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lakeshia Cousin, PhD, APRN principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gratitude Intervention in people with Cancer Survivors and African Americans, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants Who Met Inclusion Criteria Compared to Participants Approached (time frame: 8 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05473026, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.