Last reviewed · How we verify
Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors
NA trial testing Gratitude Intervention in Cancer Survivors in 26 participants. Completed in 25 July 2023.
| Lead sponsor | University of Florida |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 26 |
| Start date | 8 November 2022 |
| Primary completion | 25 July 2023 |
| Estimated completion | 25 July 2023 |
| Sites | 1 location across United States |
University of Florida
Adults 50 to 99, female only, with Cancer Survivors or African Americans. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of women who meet the inclusion criteria relative to the number of women approached.
| Group | Value | 95% CI |
|---|---|---|
| Gratitude Intervention | 13 | |
| Attention Control | 13 |
Percentage of participants completing baseline assessment measures.
| Group | Value | 95% CI |
|---|---|---|
| Gratitude Intervention | 13 | |
| Attention Control | 13 |
Percentage of participants who completed baseline assessments and completed the post-intervention assessments.
| Group | Value | 95% CI |
|---|---|---|
| Gratitude Intervention | 8 | |
| Attention Control | 11 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Gratitude Intervention | 29.8 | ± 3.7 |
| Attention Control | 29.2 | ± 3.0 |
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 t
| Group | Value | 95% CI |
|---|---|---|
| Gratitude Intervention | 0.5 | ± 1.3 |
| Attention Control | -0.3 | ± 1.0 |
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
| Group | Value | 95% CI |
|---|---|---|
| Gratitude Intervention | 3.6 | ± 8.0 |
| Attention Control | -1.8 | ± 3.1 |
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, reflec
| Group | Value | 95% CI |
|---|---|---|
| Gratitude Intervention | -2.1 | ± 4.9 |
| Attention Control | -1.3 | ± 4.5 |
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)
| Group | Value | 95% CI |
|---|---|---|
| Gratitude Intervention | -0.4 | ± 1.9 |
| Attention Control | -0.9 | ± 3.9 |
| Group | Value | 95% CI |
|---|---|---|
| Gratitude Intervention | -0.8 | ± 4.2 |
| Attention Control | 0.5 | ± 5.2 |
| Group | Value | 95% CI |
|---|---|---|
| Gratitude Intervention | -2.1 | ± 4.2 |
| Attention Control | -0.3 | ± 7.6 |
| Group | Value | 95% CI |
|---|---|---|
| Gratitude Intervention | -1.3 | ± 3.2 |
| Attention Control | -1.0 | ± 4.4 |
| Group | Value | 95% CI |
|---|---|---|
| Gratitude Intervention | 0.1 | ± 5.5 |
| Attention Control | 1.3 | ± 6.8 |
| Group | Value | 95% CI |
|---|---|---|
| Gratitude Intervention | -4.4 | ± 11.4 |
| Attention Control | 1.1 | ± 23.9 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Gratitude Intervention | 0.8 | ± 1.5 |
| Attention Control | -0.2 | ± 0.6 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Gratitude Intervention | -2.4 | ± 5.1 |
| Attention Control | -0.2 | ± 1.1 |
| Group | Value | 95% CI |
|---|---|---|
| Gratitude Intervention | 3.0 | ± 4.1 |
| Attention Control | 0.0 | ± 15.3 |
| Group | Value | 95% CI |
|---|---|---|
| Gratitude Intervention | 17.4 | ± 89.4 |
| Attention Control | 15.2 | ± 696.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Gratitude Intervention | 3.1 | ± 6.0 |
| Attention Control | 0.6 | ± 2.6 |
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05473026.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing