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Completed

NCT Number: NCT05235750

Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer

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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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-affirmation writing

Behavioral

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

Primary outcomes

  1. Mean Changes From Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline

    Time frame: 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.

  2. 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

    Time frame: 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 outcomes

  1. 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

    Time frame: 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.

  2. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 11, 2022
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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