Clinical trial · Interventional
Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer
Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer: A Preliminary Efficacy Trial
NCT05235750CI-TRIAL-00087295completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Self-affirmation writing | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Writing
- description
- This is a single-group study with one arm only.
- interventionNames
- Behavioral: Self-affirmation writing
Primary outcomes (2)
- measure
- Mean Changes From Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline
- timeFrame
- Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)
- description
- 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.
- measure
- 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
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBai 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