Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05235750
• Other study ID #: 273876
• Status: Completed
• Phase: N/A
• Start date: May 27, 2022
• Est. completion date: July 7, 2023

Study information

• Verified date: July 2023
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: July 7, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Behavioral:
• Self-affirmation writing
Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Arkansas Hospice	North Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline as well as 2-, 6-, and 8 weeks post baseline
Primary	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	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
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.	Baseline as well as 2-, 6-, and 8 weeks post baseline