N/A
N=57
Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer
Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT05235750 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Mean Changes From Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline — 23.4; 23.5; 23.7; 24.2 score on a scale — p=.83
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Self-affirmation writing (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Arkansas
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Changes From Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline |
23.4; 23.5; 23.7; 24.2 | .83 |
| PRIMARY 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 |
78.7; 80.7; 80.7; 81.2; 20.6; 19.4 | .45 |
| SECONDARY 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 |
39.5; 40.5; 41.0; 40.0; 26.6; 27.2 | .76 |
| 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 |
6.6; 5.4; 5.7; 5.3; 4.7; 3.9 | .14 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05235750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.