Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer

NCT05235750 | Completed Results

• 1 other identifier: 273876
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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 (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)

• 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

  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.

  Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)

Secondary Outcomes (2)

• 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

  Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)

• 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

  Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)

Study Arms (1)

Writing

EXPERIMENTAL

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

Behavioral: Self-affirmation writing

Interventions

Self-affirmation writing BEHAVIORAL

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

Writing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (2)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Arkansas Hospice

North Little Rock, Arkansas, 72116, United States

Location

Related Publications (1)

• Bai M, Cella D, Jeon S, Govindarajan R, Birrer MJ. Self-affirmation intervention for patients newly diagnosed with advanced cancer: a preliminary efficacy trial. J Psychosoc Oncol. 2025;43(4):593-615. doi: 10.1080/07347332.2025.2450013. Epub 2025 Jan 15.

  PMID: 39812781 DERIVED

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Dr. Mei Bai
• Organization: University of Arkansas for Medical Sciences

MBai@uams.edu

501-603-1900

Study Officials

• Mei Bai, Ph.D.

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 11, 2022
• Study Start: May 27, 2022
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: March 17, 2025
• Results First Posted: March 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)