Neoplasms
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSelf-affirmation writing
Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer
Sponsors
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* within 8 weeks of being informed of diagnosis (primary or recurrent) * cancer stage III or IV of a primary solid tumor, or a high-grade hematological malignancy, and * age 18 years or older
Exclusion criteria
* medical condition precluding participation (e.g., too ill or fatigued, acute mental confusion as determined by the treating physician), or * enrolled in other psychosocial experiments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Changes From Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline | Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4) | 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. |
| 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 | Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4) | 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. |
| 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 | Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 54 |
| Total | 54 |
Baseline characteristics
| Characteristic | Writing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 25 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age, Continuous | 62.8 years STANDARD_DEVIATION 9.9 |
| Cancer site Breast | 2 Participants |
| Cancer site Gastrointestinal (GI) | 18 Participants |
| Cancer site Gynecological (GYN) | 10 Participants |
| Cancer site Head and neck | 7 Participants |
| Cancer site Hematological | 1 Participants |
| Cancer site Lung | 13 Participants |
| Cancer site Prostate | 3 Participants |
| Education College | 26 Participants |
| Education Graduate school | 5 Participants |
| Education High school | 21 Participants |
| Education Unknown or not reported | 1 Participants |
| Education Up to 8th grade | 1 Participants |
| Ever wrote a diary in life no | 38 Participants |
| Ever wrote a diary in life yes | 16 Participants |
| Marital status divorced | 9 Participants |
| Marital status married | 31 Participants |
| Marital status single | 7 Participants |
| Marital status widowed | 7 Participants |
| Perceived threat from cancer diagnosis a great deal threatening | 16 Participants |
| Perceived threat from cancer diagnosis a little threatening | 13 Participants |
| Perceived threat from cancer diagnosis moderately threatening | 14 Participants |
| Perceived threat from cancer diagnosis not or hardly threatening | 11 Participants |
| Preference to talk no | 13 Participants |
| Preference to talk not sure | 8 Participants |
| Preference to talk yes | 33 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 0 Participants |
| Race/Ethnicity, Customized Ethnicity non-Hispanic | 54 Participants |
| Race/Ethnicity, Customized Race African American | 12 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants |
| Race/Ethnicity, Customized Race Caucasian | 41 Participants |
| Religious affiliation Catholic | 3 Participants |
| Religious affiliation None | 10 Participants |
| Religious affiliation Other | 23 Participants |
| Religious affiliation Protestant | 17 Participants |
| Religious affiliation Undisclosed | 1 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 27 Participants |
| Should one have a religious affiliation to be spiritual? no | 37 Participants |
| Should one have a religious affiliation to be spiritual? yes | 17 Participants |
| Stage of cancer III | 17 Participants |
| Stage of cancer IV | 31 Participants |
| Stage of cancer recurrent | 2 Participants |
| Stage of cancer unstaged | 4 Participants |
| Time since cancer diagnosis | 46.3 days STANDARD_DEVIATION 23.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 57 |
| other Total, other adverse events | 0 / 57 |
| serious Total, serious adverse events | 0 / 57 |
Outcome results
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.
Time frame: Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Writing | 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 | FACT-G (total score) at T1 | 78.7 score on a scale | Standard Deviation 15.2 |
| Writing | 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 | FACT-G (total score) at T2 | 80.7 score on a scale | Standard Deviation 16.3 |
| Writing | 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 | FACT-G (total score) at T3 | 80.7 score on a scale | Standard Deviation 14.9 |
| Writing | 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 | FACT-G (total score) at T4 | 81.2 score on a scale | Standard Deviation 17 |
| Writing | 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 | PWB at T1 | 20.6 score on a scale | Standard Deviation 4.8 |
| Writing | 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 | PWB at T2 | 19.4 score on a scale | Standard Deviation 6 |
| Writing | 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 | PWB at T3 | 19.3 score on a scale | Standard Deviation 5.3 |
| Writing | 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 | PWB at T4 | 19.5 score on a scale | Standard Deviation 5.7 |
| Writing | 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 | SWB at T1 | 22.7 score on a scale | Standard Deviation 4.4 |
| Writing | 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 | SWB at T2 | 24.1 score on a scale | Standard Deviation 4.3 |
| Writing | 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 | SWB at T3 | 23.5 score on a scale | Standard Deviation 4.2 |
| Writing | 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 | SWB at T4 | 23.6 score on a scale | Standard Deviation 4.4 |
| Writing | 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 | EWB at T1 | 18.6 score on a scale | Standard Deviation 3.9 |
| Writing | 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 | EWB at T2 | 19.1 score on a scale | Standard Deviation 4.4 |
| Writing | 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 | EWB at T3 | 19.3 score on a scale | Standard Deviation 4.5 |
| Writing | 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 | EWB at T4 | 19.5 score on a scale | Standard Deviation 4.5 |
| Writing | 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 | FWB at T1 | 16.8 score on a scale | Standard Deviation 6.8 |
| Writing | 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 | FWB at T2 | 18.1 score on a scale | Standard Deviation 6.3 |
| Writing | 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 | FWB at T3 | 18.7 score on a scale | Standard Deviation 5.7 |
| Writing | 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 | FWB at T4 | 18.5 score on a scale | Standard Deviation 6.2 |
| Writing | 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 | Gf7 at T1 | 2.4 score on a scale | Standard Deviation 1.3 |
| Writing | 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 | Gf7 at T2 | 2.6 score on a scale | Standard Deviation 1.2 |
| Writing | 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 | Gf7 at T3 | 2.7 score on a scale | Standard Deviation 1.3 |
| Writing | 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 | Gf7 at T4 | 2.6 score on a scale | Standard Deviation 1.2 |
| Writing | 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 | Ge6 at T1 | 2.8 score on a scale | Standard Deviation 1.1 |
| Writing | 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 | Ge6 at T2 | 2.8 score on a scale | Standard Deviation 1.2 |
| Writing | 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 | Ge6 at T3 | 3.0 score on a scale | Standard Deviation 1.2 |
| Writing | 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 | Ge6 at T4 | 3.0 score on a scale | Standard Deviation 1.1 |
Comparison: We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for the FACT-G at scale, factor and item levels expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).p-value: 0.45Mixed Models Analysis
p-value: 0.29Mixed Models Analysis
p-value: 0.46Mixed Models Analysis
p-value: 0.79Mixed Models Analysis
p-value: 0.05Mixed Models Analysis
p-value: 0.03Mixed Models Analysis
p-value: 0.82Mixed Models Analysis
p-value: 0.58Mixed Models Analysis
p-value: 0.56Mixed Models Analysis
p-value: 0.58Mixed Models Analysis
p-value: 0.58Mixed Models Analysis
p-value: 0.34Mixed Models Analysis
p-value: 0.27Mixed Models Analysis
p-value: 0.62Mixed Models Analysis
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.
Time frame: Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Writing | Mean Changes From Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline | RSES at T1 | 23.4 score on a scale | Standard Deviation 3.8 |
| Writing | Mean Changes From Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline | RSES at T2 | 23.5 score on a scale | Standard Deviation 4.1 |
| Writing | Mean Changes From Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline | RSES at T3 | 23.7 score on a scale | Standard Deviation 4.2 |
| Writing | Mean Changes From Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline | RSES at T4 | 24.2 score on a scale | Standard Deviation 4.7 |
Comparison: We analyzed short- (at 6 weeks post-baseline or T3) and longer-term differences (at 8 weeks post-baseline or T4) for the RSES, expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).p-value: 0.83Mixed Models Analysis
p-value: 0.91Mixed Models Analysis
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.
Time frame: Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Writing | 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 | HADS-A at T1 | 6.6 score on a scale | Standard Deviation 3.9 |
| Writing | 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 | HADS-A at T2 | 5.4 score on a scale | Standard Deviation 3.3 |
| Writing | 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 | HADS-A at T3 | 5.7 score on a scale | Standard Deviation 4 |
| Writing | 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 | HADS-A at T4 | 5.3 score on a scale | Standard Deviation 4.1 |
| Writing | 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 | HADS-D at T1 | 4.7 score on a scale | Standard Deviation 3.2 |
| Writing | 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 | HADS-D at T2 | 3.9 score on a scale | Standard Deviation 2.8 |
| Writing | 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 | HADS-D at T3 | 4.2 score on a scale | Standard Deviation 3.5 |
| Writing | 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 | HADS-D at T4 | 4.5 score on a scale | Standard Deviation 3.7 |
Comparison: We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for two subscales HADS-A and HADS-D respectively, expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).p-value: 0.14Mixed Models Analysis
p-value: 0.14Mixed Models Analysis
p-value: 0.32Mixed Models Analysis
p-value: 0.2Mixed Models Analysis
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.
Time frame: Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Writing | 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 | FACIT-Sp-12 (total) at T1 | 39.5 score on a scale | Standard Deviation 8.2 |
| Writing | 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 | FACIT-Sp-12 (total) at T2 | 40.5 score on a scale | Standard Deviation 6.8 |
| Writing | 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 | FACIT-Sp-12 (total) at T3 | 41.0 score on a scale | Standard Deviation 7 |
| Writing | 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 | FACIT-Sp-12 (total) at T4 | 40.0 score on a scale | Standard Deviation 8 |
| Writing | 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 | M/P at T1 | 26.6 score on a scale | Standard Deviation 5.3 |
| Writing | 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 | M/P at T2 | 27.2 score on a scale | Standard Deviation 4.3 |
| Writing | 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 | M/P at T3 | 26.9 score on a scale | Standard Deviation 5 |
| Writing | 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 | M/P at T4 | 26.8 score on a scale | Standard Deviation 5.7 |
| Writing | 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 | Faith at T1 | 12.9 score on a scale | Standard Deviation 3.9 |
| Writing | 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 | Faith at T2 | 13.2 score on a scale | Standard Deviation 3.5 |
| Writing | 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 | Faith at T3 | 14.1 score on a scale | Standard Deviation 3.1 |
| Writing | 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 | Faith at T4 | 13.2 score on a scale | Standard Deviation 3.6 |
| Writing | 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 | Faith (revised) at T1 | 13.2 score on a scale | Standard Deviation 3.5 |
| Writing | 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 | Faith (revised) at T2 | 13.7 score on a scale | Standard Deviation 2.9 |
| Writing | 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 | Faith (revised) at T3 | 14.1 score on a scale | Standard Deviation 2.9 |
| Writing | 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 | Faith (revised) at T4 | 13.5 score on a scale | Standard Deviation 3.4 |
| Writing | 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 | FACIT-Sp-12 total (revised) at T1 | 39.8 score on a scale | Standard Deviation 7.7 |
| Writing | 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 | FACIT-Sp-12 total (revised) at T2 | 40.9 score on a scale | Standard Deviation 6.6 |
| Writing | 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 | FACIT-Sp-12 total (revised) at T3 | 40.9 score on a scale | Standard Deviation 6.9 |
| Writing | 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 | FACIT-Sp-12 total (revised) at T4 | 39.8 score on a scale | Standard Deviation 8.3 |
Comparison: We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for the FACIT-Sp-12 at scale and factor levels, expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).p-value: 0.76Mixed Models Analysis
p-value: 0.19Mixed Models Analysis
p-value: 0.35Mixed Models Analysis
p-value: 0.99Mixed Models Analysis
p-value: 0.46Mixed Models Analysis
p-value: 0.24Mixed Models Analysis
p-value: 0.55Mixed Models Analysis
p-value: 0.8Mixed Models Analysis
p-value: 0.34Mixed Models Analysis
p-value: 0.91Mixed Models Analysis