Trial Outcomes & Findings for Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors (NCT NCT05473026)
NCT ID: NCT05473026
Last Updated: 2024-09-19
Results Overview
Percentage of women who meet the inclusion criteria relative to the number of women approached.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
8 months
Results posted on
2024-09-19
Participant Flow
Participants were recruited using organic social media recruitment, flyers, and multiple specialized strategies, including the OAIC Pepper Center Clinical Research Core - Participant Registry (IRB201601352), UF Health Cancer Center Community-Partnered Cancer Disparities Research Collaborative, UF Health Cancer Center Community Outreach and Engagement, UF Healthstreet, Integrated Data Repository, and UF Consent2Share Registries. Potential participants were screened for eligibility via telephone.
Participant milestones
| Measure |
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.
Gratitude Intervention: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
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.
Gratitude Intervention: 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
Baseline Characteristics
Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors
Baseline characteristics by cohort
| Measure |
Gratitude Intervention
n=13 Participants
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.
Gratitude Intervention: Gratitude journaling and goal setting for exercise readiness over eight weeks.
|
Attention Control
n=13 Participants
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.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
66.7 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
65.0 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Body Mass Index
|
36.1 kg/m2
STANDARD_DEVIATION 10.7 • n=5 Participants
|
31.7 kg/m2
STANDARD_DEVIATION 5.7 • n=7 Participants
|
33.9 kg/m2
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Weight
|
222.5 pounds
STANDARD_DEVIATION 69.3 • n=5 Participants
|
181.1 pounds
STANDARD_DEVIATION 39.8 • n=7 Participants
|
201.8 pounds
STANDARD_DEVIATION 59.3 • n=5 Participants
|
|
Height
|
65.5 inches
STANDARD_DEVIATION 3.2 • n=5 Participants
|
63.5 inches
STANDARD_DEVIATION 2.8 • n=7 Participants
|
64.5 inches
STANDARD_DEVIATION 3.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 monthsPercentage of women who meet the inclusion criteria relative to the number of women approached.
Outcome measures
| Measure |
Gratitude Intervention
n=13 Participants
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.
Gratitude Intervention: Gratitude journaling and goal setting for exercise readiness over eight weeks.
|
Attention Control
n=13 Participants
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.
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|---|---|---|
|
Participants Who Met Inclusion Criteria Compared to Participants Approached
|
13 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Week 0Percentage of participants completing baseline assessment measures.
Outcome measures
| Measure |
Gratitude Intervention
n=13 Participants
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.
Gratitude Intervention: Gratitude journaling and goal setting for exercise readiness over eight weeks.
|
Attention Control
n=13 Participants
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.
|
|---|---|---|
|
Participant Completion of Baseline Assessment Measures
|
13 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 8Percentage of participants who completed baseline assessments and completed the post-intervention assessments.
Outcome measures
| Measure |
Gratitude Intervention
n=13 Participants
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.
Gratitude Intervention: Gratitude journaling and goal setting for exercise readiness over eight weeks.
|
Attention Control
n=13 Participants
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.
|
|---|---|---|
|
Participant Completion of Both Baseline Assessments and Post-intervention Assessments
|
8 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Week 8We 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.
Outcome measures
| Measure |
Gratitude Intervention
n=13 Participants
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.
Gratitude Intervention: Gratitude journaling and goal setting for exercise readiness over eight weeks.
|
Attention Control
n=13 Participants
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.
|
|---|---|---|
|
Treatment Satisfaction Using Client Satisfaction Questionnaire (CSQ-8)
|
29.8 score on a scale
Standard Deviation 3.7
|
29.2 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Week 0, Week 8The 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.
Outcome measures
| Measure |
Gratitude Intervention
n=13 Participants
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.
Gratitude Intervention: Gratitude journaling and goal setting for exercise readiness over eight weeks.
|
Attention Control
n=13 Participants
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.
|
|---|---|---|
|
Change in Dispositional Gratitude From Baseline to Post-intervention
|
0.5 score on a scale
Standard Deviation 1.3
|
-0.3 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Week 0, Week 8The 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.
Outcome measures
| Measure |
Gratitude Intervention
n=13 Participants
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.
Gratitude Intervention: Gratitude journaling and goal setting for exercise readiness over eight weeks.
|
Attention Control
n=13 Participants
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.
|
|---|---|---|
|
Change in Spiritual Well-being From Baseline to Post-intervention
|
3.6 score on a scale
Standard Deviation 8.0
|
-1.8 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Week 0, Week 8The 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.
Outcome measures
| Measure |
Gratitude Intervention
n=13 Participants
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.
Gratitude Intervention: Gratitude journaling and goal setting for exercise readiness over eight weeks.
|
Attention Control
n=13 Participants
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.
|
|---|---|---|
|
Change in Distress From Baseline to Post-intervention
|
-2.1 score on a scale
Standard Deviation 4.9
|
-1.3 score on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Week 0, Week 8The 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.
Outcome measures
| Measure |
Gratitude Intervention
n=13 Participants
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.
Gratitude Intervention: Gratitude journaling and goal setting for exercise readiness over eight weeks.
|
Attention Control
n=13 Participants
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.
|
|---|---|---|
|
Change in Superwoman Schema (Racial and Gender Identity) From Baseline to Post-intervention
Suppress emotions subscale
|
-0.8 score on a scale
Standard Deviation 4.2
|
0.5 score on a scale
Standard Deviation 5.2
|
|
Change in Superwoman Schema (Racial and Gender Identity) From Baseline to Post-intervention
Strength subscale
|
-0.4 score on a scale
Standard Deviation 1.9
|
-0.9 score on a scale
Standard Deviation 3.9
|
|
Change in Superwoman Schema (Racial and Gender Identity) From Baseline to Post-intervention
Resistance to vulnerability subscale
|
-2.1 score on a scale
Standard Deviation 4.2
|
-0.3 score on a scale
Standard Deviation 7.6
|
|
Change in Superwoman Schema (Racial and Gender Identity) From Baseline to Post-intervention
Motivation to succeed subscale
|
-1.3 score on a scale
Standard Deviation 3.2
|
-1.0 score on a scale
Standard Deviation 4.4
|
|
Change in Superwoman Schema (Racial and Gender Identity) From Baseline to Post-intervention
Care for others subscale
|
0.1 score on a scale
Standard Deviation 5.5
|
1.3 score on a scale
Standard Deviation 6.8
|
|
Change in Superwoman Schema (Racial and Gender Identity) From Baseline to Post-intervention
Total score
|
-4.4 score on a scale
Standard Deviation 11.4
|
1.1 score on a scale
Standard Deviation 23.9
|
SECONDARY outcome
Timeframe: Week 0, Week 8The 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.
Outcome measures
| Measure |
Gratitude Intervention
n=13 Participants
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.
Gratitude Intervention: Gratitude journaling and goal setting for exercise readiness over eight weeks.
|
Attention Control
n=13 Participants
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.
|
|---|---|---|
|
Change in Exercise Readiness From Baseline to Post-intervention
|
0.8 score on a scale
Standard Deviation 1.5
|
-0.2 score on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Week 0, Week 8The 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).
Outcome measures
| Measure |
Gratitude Intervention
n=13 Participants
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.
Gratitude Intervention: Gratitude journaling and goal setting for exercise readiness over eight weeks.
|
Attention Control
n=13 Participants
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.
|
|---|---|---|
|
Change in Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6), Growth/Differentiation Factor-15 (GDF15) From Baseline to Post-intervention
TNF-a (pg/mL)
|
-2.4 pg/mL
Standard Deviation 5.1
|
-0.2 pg/mL
Standard Deviation 1.1
|
|
Change in Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6), Growth/Differentiation Factor-15 (GDF15) From Baseline to Post-intervention
IL-6 (pg/mL)
|
3.0 pg/mL
Standard Deviation 4.1
|
0.0 pg/mL
Standard Deviation 15.3
|
|
Change in Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6), Growth/Differentiation Factor-15 (GDF15) From Baseline to Post-intervention
GDF-15 (pg/mL)
|
17.4 pg/mL
Standard Deviation 89.4
|
15.2 pg/mL
Standard Deviation 696.4
|
SECONDARY outcome
Timeframe: Week 0, Week 8The 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.
Outcome measures
| Measure |
Gratitude Intervention
n=13 Participants
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.
Gratitude Intervention: Gratitude journaling and goal setting for exercise readiness over eight weeks.
|
Attention Control
n=13 Participants
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.
|
|---|---|---|
|
Change in C-Reactive Protein From Baseline to Post-intervention
|
3.1 mg/L
Standard Deviation 6.0
|
0.6 mg/L
Standard Deviation 2.6
|
Adverse Events
Gratitude Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lakeshia Cousin, PhD, APRN, AGPCNP-BC
University of Florida
Phone: 352-273-6318
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place