Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer

University of Arkansas

Status: Completed

Conditions: Neoplasms

Treatments: Behavioral: Self-affirmation writing

Study type: Interventional

Funder types: Other

Identifiers

NCT05235750

273876

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

Writing

Experimental group

Description:

This is a single-group study with one arm only.

Treatment:

Behavioral: Self-affirmation writing