Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer

Study Overview
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Brief Summary
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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 12-item Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being Scale (FACIT-Sp-12), in its current and revised forms. Potential participants will be referred and 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 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.

Official Title
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Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer: A Preliminary Efficacy Trial

Conditions
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Neoplasms

Intervention / Treatment
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* Behavioral: Self-affirmation writing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Writing<br>This is a single-group study with one arm only. | Behavioral: Self-affirmation writing<br>* Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 as well as 2-, 6-, and 8 weeks post baseline | 
| Mean Changes from Baseline in Quality of Life 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. | Baseline as well as 2-, 6-, and 8 weeks post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Changes from Baseline in Spiritual Well-Being Scores on the 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline | Changes include raw score changes and standardized mean differences. Scores on the 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being scale (FACIT-Sp-12) range from 0 to 48, with higher score indicating higher level of spiritual well-being. | Baseline as well as 2-, 6-, and 8 weeks post baseline | 
| 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. | Baseline as well as 2-, 6-, and 8 weeks post baseline |