Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-27

Study Completion Date

2023-07-07

Brief Summary

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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.

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Detailed Description

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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 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.

Conditions

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Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Writing

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

Group Type EXPERIMENTAL

Self-affirmation writing

Intervention Type BEHAVIORAL

Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer

Interventions

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Self-affirmation writing

Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No