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The goal of this clinical trial is to learn if a brief writing intervention works to improve quality of life outcomes in adult patients newly diagnosed with advanced stage cancer.
A diagnosis of cancer may challenge one's former assumptions and beliefs about themselves and the world and potentially compromise quality of life (QoL). The primary aim of the study is to explore the preliminary efficacy of an intervention to protect individuals from the negative psychological impact of the cancer diagnosis. The secondary aim is to test the validity of the Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being 12 item Scale (FACIT-Sp-12), in its current and revised forms. Potential participants will be enrolled from two study sites as per protocol: the Winthrop P. Rockefeller Cancer Institute at the University of Arkansas for Medical Sciences (UAMS) and the Arkansas Hospice respectively, and will be asked to write as guided by the researcher for 4 weeks. Study outcomes will be assessed at baseline, 2-, 6- and 8-weeks post baseline. It is hypothesized that self-affirmation via writing at the time following a diagnosis of an advanced cancer by affirming values or beliefs that are salient to self will help enhance self-esteem, reinforce spiritual well-being, decrease levels of anxiety or depression, and improve QoL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Writing | Experimental | This is a single-group study with one arm only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-affirmation writing | Behavioral | Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Changes From Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline | Changes include raw score changes and standardized mean differences. Scores on the Rosenberg Self-esteem Scale range from 0 to 30, with higher score indicating higher level of self-esteem. | Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4) |
| Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline | Changes include raw score changes and standardized mean differences. Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) range from 0 to 108, with higher score indicating higher level of quality of life. Each subscale ranging from 0 to 28, with higher score indicating higher level of quality of life. The raw scores of overall QoL (total FACT-G), four composite domains (physical well-being, PWB; social/family well-being, SWB; emotional well-being, EWB; functional well-being, FWB), global QoL (item Gf7 "I am content with the quality of my life right now") and one item pertinent to this study (Ge6 "I worry that my condition will get worse") were presented below. | Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline | Changes include raw score changes and standardized mean differences. The FACIT-Sp-12 scale measures an individual's level of spiritual well-being, specifically assessing their sense of meaning, peace, and faith in life, with higher scores indicating a better level of spiritual well-being and lower scores a worse level of spiritual well-being. It consists of 12 items rated on a 5-point Likert scale (0 = Not at all to 4 = Very much). The FACIT-Sp-12 Scale consists of 2 sub-scales Meaning/Peace (M/P) with a range of 0-32, and Faith ranging from 1-16. Possible overall spiritual well-being or FACIT-Sp-12 (total) range from 0 to 48. The revised Faith subscale as well as the revised FACIT-Sp-12 scale have the same scale range of the original measures. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mei Bai, Ph.D. | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
| Arkansas Hospice |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39812781 | Derived | Bai M, Cella D, Jeon S, Govindarajan R, Birrer MJ. Self-affirmation intervention for patients newly diagnosed with advanced cancer: a preliminary efficacy trial. J Psychosoc Oncol. 2025;43(4):593-615. doi: 10.1080/07347332.2025.2450013. Epub 2025 Jan 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Writing | This is a single-group study with one arm only. Self-affirmation writing: Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Two patients were deceased shortly after enrollment and one was unable to reach again, leaving a total of 54 participants who were able to complete baseline data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Writing | This is a single-group study with one arm only. Self-affirmation writing: Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Changes From Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline | Changes include raw score changes and standardized mean differences. Scores on the Rosenberg Self-esteem Scale range from 0 to 30, with higher score indicating higher level of self-esteem. | Posted | Mean | Standard Deviation | score on a scale | Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4) |
|
|
Eight weeks following baseline data collection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Writing | This is a single-group study with one arm only. Self-affirmation writing: Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mei Bai | University of Arkansas for Medical Sciences | 501-603-1900 | MBai@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 27, 2024 | Jul 4, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4) |
| Mean Changes From Baseline in Anxiety and Depression Scores on the Hospital Anxiety and Depression Scale (HADS) to Two-, Six-, and Eight Weeks Post Baseline | Changes include raw score changes and standardized mean differences. Scores on the Hospital Anxiety and Depression Scale (HADS) range from 0 to 42, with higher score indicating higher level of anxiety or depression. The two subscales HADS anxiety (HADS-A) and HADS depression (HADS-D) were analyzed separately. Each sub-scale has a range from 0-21, with the higher score indicating higher level of anxiety or depression. | Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4) |
| North Little Rock |
| Arkansas |
| 72116 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| Religious affiliation | Count of Participants | Participants |
|
| Time since cancer diagnosis | Mean | Standard Deviation | days |
|
| Stage of cancer | Count of Participants | Participants |
|
| Cancer site | Count of Participants | Participants |
|
| Preference to talk | Count of Participants | Participants |
|
| Ever wrote a diary in life | Count of Participants | Participants |
|
| Should one have a religious affiliation to be spiritual? | Count of Participants | Participants |
|
| Perceived threat from cancer diagnosis | Count of Participants | Participants |
|
| Participants |
|
|
|
| Primary | Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline | Changes include raw score changes and standardized mean differences. Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) range from 0 to 108, with higher score indicating higher level of quality of life. Each subscale ranging from 0 to 28, with higher score indicating higher level of quality of life. The raw scores of overall QoL (total FACT-G), four composite domains (physical well-being, PWB; social/family well-being, SWB; emotional well-being, EWB; functional well-being, FWB), global QoL (item Gf7 "I am content with the quality of my life right now") and one item pertinent to this study (Ge6 "I worry that my condition will get worse") were presented below. | Posted | Mean | Standard Deviation | score on a scale | Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4) |
|
|
|
|
| Secondary | Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline | Changes include raw score changes and standardized mean differences. The FACIT-Sp-12 scale measures an individual's level of spiritual well-being, specifically assessing their sense of meaning, peace, and faith in life, with higher scores indicating a better level of spiritual well-being and lower scores a worse level of spiritual well-being. It consists of 12 items rated on a 5-point Likert scale (0 = Not at all to 4 = Very much). The FACIT-Sp-12 Scale consists of 2 sub-scales Meaning/Peace (M/P) with a range of 0-32, and Faith ranging from 1-16. Possible overall spiritual well-being or FACIT-Sp-12 (total) range from 0 to 48. The revised Faith subscale as well as the revised FACIT-Sp-12 scale have the same scale range of the original measures. | Posted | Mean | Standard Deviation | score on a scale | Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4) |
|
|
|
|
| Secondary | Mean Changes From Baseline in Anxiety and Depression Scores on the Hospital Anxiety and Depression Scale (HADS) to Two-, Six-, and Eight Weeks Post Baseline | Changes include raw score changes and standardized mean differences. Scores on the Hospital Anxiety and Depression Scale (HADS) range from 0 to 42, with higher score indicating higher level of anxiety or depression. The two subscales HADS anxiety (HADS-A) and HADS depression (HADS-D) were analyzed separately. Each sub-scale has a range from 0-21, with the higher score indicating higher level of anxiety or depression. | Posted | Mean | Standard Deviation | score on a scale | Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4) |
|
|
|
|
| 3 |
| 57 |
| 0 |
| 57 |
| 0 |
| 57 |
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| Title | Measurements |
|---|---|
|
| FACT-G (total score) at T4 |
|
| PWB at T1 |
|
| PWB at T2 |
|
| PWB at T3 |
|
| PWB at T4 |
|
| SWB at T1 |
|
| SWB at T2 |
|
| SWB at T3 |
|
| SWB at T4 |
|
| EWB at T1 |
|
| EWB at T2 |
|
| EWB at T3 |
|
| EWB at T4 |
|
| FWB at T1 |
|
| FWB at T2 |
|
| FWB at T3 |
|
| FWB at T4 |
|
| Gf7 at T1 |
|
| Gf7 at T2 |
|
| Gf7 at T3 |
|
| Gf7 at T4 |
|
| Ge6 at T1 |
|
| Ge6 at T2 |
|
| Ge6 at T3 |
|
| Ge6 at T4 |
|
| Other |
| Mixed Models Analysis | .29 | The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for the total FACT-G. | Mean Difference (Net) | -3.3 | 2-Sided | The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for the total FACT-G. | Other |
| Mixed Models Analysis | .46 | The above p value refers to the difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for physical well-being (PWB) as measured by the FACT-G. | Mean Difference (Net) | 0.8 | 2-Sided | The above value represents net difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for physical well-being (PWB) as measured by the FACT-G. | Other |
| Mixed Models Analysis | .79 | The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for physical well-being (PWB) as measured by the FACT-G. | Mean Difference (Net) | 0.2 | 2-Sided | The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for physical well-being (PWB) as measured by the FACT-G. | Other |
| Mixed Models Analysis | .05 | The above p value refers to the difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for social/family well-being (SWB) as measured by the FACT-G. | Mean Difference (Net) | -2.1 | 2-Sided | The above value represents net difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for social/family well-being (SWB) as measured by the FACT-G. | Other |
| Mixed Models Analysis | .03 | The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for social/family well-being (SWB) as measured by the FACT-G. | Mean Difference (Net) | -2.4 | 2-Sided | The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for social/family well-being (SWB) as measured by the FACT-G. | Other |
| Mixed Models Analysis | .82 | The above p value refers to the difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for emotional well-being (EWB) as measured by the FACT-G. | Mean Difference (Net) | -0.2 | 2-Sided | The above value represents net difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for emotional well-being (EWB) as measured by the FACT-G. | Other |
| Mixed Models Analysis | .58 | The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for emotional well-being (EWB) as measured by the FACT-G. | Mean Difference (Net) | -0.5 | 2-Sided | The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for emotional well-being (EWB) as measured by the FACT-G. | Other |
| Mixed Models Analysis | .56 | The above p value refers to the difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for functional well-being (FWB) as measured by the FACT-G. | Mean Difference (Net) | -0.8 | 2-Sided | The above value represents net difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for functional well-being (FWB) as measured by the FACT-G. | Other |
| Mixed Models Analysis | .58 | The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for functional well-being (FWB) as measured by the FACT-G. | Mean Difference (Net) | -0.7 | 2-Sided | The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for functional well-being (FWB) as measured by the FACT-G. | Other |
| Mixed Models Analysis | .58 | The above p value refers to the difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for Global QoL (item G7 "I am content with the quality of my life right now") as measured by the FACT-G. | Mean Difference (Net) | -0.2 | 2-Sided | The above value represents net difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for Global QoL (item G7 "I am content with the quality of my life right now") as measured by the FACT-G. | Other |
| Mixed Models Analysis | .34 | The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)] for Global QoL (item G7 "I am content with the quality of my life right now") as measured by the FACT-G. | Mean Difference (Net) | -0.3 | 2-Sided | The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for Global QoL (item G7 "I am content with the quality of my life right now") as measured by the FACT-G. | Other |
| Mixed Models Analysis | .27 | The above p value refers to the difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for item Ge6 "I worry that my condition will get worse" as measured by the FACT-G. | Mean Difference (Net) | 0.4 | 2-Sided | The above value represents net difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for item Ge6 "I worry that my condition will get worse" as measured by the FACT-G. | Other |
| Mixed Models Analysis | .62 | The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for item Ge6 "I worry that my condition will get worse" as measured by the FACT-G. | Mean Difference (Net) | 0 | 2-Sided | The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for item Ge6 "I worry that my condition will get worse" as measured by the FACT-G. | Other |
| Title | Measurements |
|---|---|
|
| FACIT-Sp-12 (total) at T4 |
|
| M/P at T1 |
|
| M/P at T2 |
|
| M/P at T3 |
|
| M/P at T4 |
|
| Faith at T1 |
|
| Faith at T2 |
|
| Faith at T3 |
|
| Faith at T4 |
|
| Faith (revised) at T1 |
|
| Faith (revised) at T2 |
|
| Faith (revised) at T3 |
|
| Faith (revised) at T4 |
|
| FACIT-Sp-12 total (revised) at T1 |
|
| FACIT-Sp-12 total (revised) at T2 |
|
| FACIT-Sp-12 total (revised) at T3 |
|
| FACIT-Sp-12 total (revised) at T4 |
|
| Other |
| Mixed Models Analysis | .19 | The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for the total FACIT-Sp-12. | Mean Difference (Net) | -2.1 | 2-Sided | The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for the total FACIT-Sp-12. | Other |
| Mixed Models Analysis | .35 | The above p value refers to the difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12. | Mean Difference (Net) | -1.0 | 2-Sided | The above value represents net difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12. | Other |
| Mixed Models Analysis | .99 | The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12. | Mean Difference (Net) | -1.9 | 2-Sided | The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12. | Other |
| Mixed Models Analysis | .46 | The above p value refers to the difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for the Faith factor of the FACIT-Sp-12. | Mean Difference (Net) | 0.4 | 2-Sided | The above value represents net difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for the Faith factor of the FACIT-Sp-12. | Other |
| Mixed Models Analysis | .24 | The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for the Faith factor of the FACIT-Sp-12. | Mean Difference (Net) | -0.7 | 2-Sided | The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for the Faith factor of the FACIT-Sp-12. | Other |
| Mixed Models Analysis | .55 | The above p value refers to the difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for the revised Faith factor of the FACIT-Sp-12. | Mean Difference (Net) | -0.4 | 2-Sided | The above value represents net difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for the revised Faith factor of the FACIT-Sp-12. | Other |
| Mixed Models Analysis | .80 | The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for the revised Faith factor of the FACIT-Sp-12. | Mean Difference (Net) | -0.9 | 2-Sided | The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for the revised Faith factor of the FACIT-Sp-12. | Other |
| Mixed Models Analysis | .34 | The above p value refers to the difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for the total FACIT-Sp-12 (revised). | Mean Difference (Net) | -1.5 | 2-Sided | The above value represents net difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for the total FACIT-Sp-12 (revised). | Other |
| Mixed Models Analysis | .91 | The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for the total FACIT-Sp-12 (revised). | Mean Difference (Net) | -3.0 | 2-Sided | The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for the total FACIT-Sp-12 (revised). | Other |
| Title | Measurements |
|---|---|
|
| HADS-A at T4 |
|
| HADS-D at T1 |
|
| HADS-D at T2 |
|
| HADS-D at T3 |
|
| HADS-D at T4 |
|
| Other |
| Mixed Models Analysis | .14 | The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for HADS-anxiety subscale (HADS-A). | Mean Difference (Net) | 1.2 | 2-Sided | The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for HADS-anxiety subscale (HADS-A). | Other |
| Mixed Models Analysis | .32 | The above p value refers to the difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for HADS-depression subscale (HADS-D). | Median Difference (Net) | 0.6 | 2-Sided | The above value represents net difference between post-intervention change and pre-intervention change (or [(T3-T2)-(T2-T1)]) for HADS-depression subscale (HADS-D). | Other |
| Mixed Models Analysis | .20 | The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for HADS-depression subscale (HADS-D). | Mean Difference (Net) | 0.9 | 2-Sided | The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or [(T4-T2)-(T2-T1)]) for HADS-depression subscale (HADS-D). | Other |