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Adaptation, feasibility, and investigation of CALM on cognitive and psychological problems of patients with advanced cancer

Adaptation and Feasibility of Managing Cancer and Living Meaningfully (CALM) Intervention for Patients with Advanced Cancer in Iran: Investigating Its Cognitive and Psychological Impacts

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230627058602N1
Enrollment
50
Registered
2023-07-22
Start date
2023-07-23
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant solid tumor as follows: stage III B or IV lung cancer

Interventions

Intervention group: Managing Cancer and Living Meaningfully (CALM) is a brief, semi structured and manualized psychotherapeutic intervention intended to treat and prevent depression and end-of-life di
changes in self and relations with close others
spiritual well-being and sense of meaning and purpose
and preparing for the future, sustaining hope, and facing mortality. The timing of sessions and content explored are guided by the patient’s interests and priorities. Interventions are adapted to pati

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Fluency in Persian language Diploma or higher level of education and living in Tehran Diagnosis of the metastatic solid tumor as follows: stage III B or IV lung cancer; any stage of pancreatic cancer, stage III or IV ovarian and fallopian tube cancers, or stage IV of other gynecological cancers; and stage IV breast, genitourinary, gastrointestinal, melanoma, sarcoma, or endocrine cancers Life expectancy 12 to 18 months A score greater than or equal10 on the Patient Health Questionnaire (PHQ9) A score greater than 5 on the Post-traumatic Stress Disorder Checklist (PCL-5) A score greater than or equal to 20 on the Death and Dying Distress Scale (DADDS) A score lesser than 27 on Mini-Mental State Examination (MMSE)

Exclusion criteria

Exclusion criteria: Language or communication barriers hindering psychotherapy Consciousness problems or inability to participate in assessment and intervention sessions Disorder and features of acute psychosis Suicidal thoughts and attempts Severe sensorimotor disabilities Brain damage or any medical condition that better explains the cognitive and psychological problems of patients with advanced cancer Concomitant psychotherapy

Design outcomes

Primary

MeasureTime frame
The score of depression symptoms in the Patient Health Questionnaire (PHQ-9). Timepoint: Before starting the intervention, the third month for evaluation and the 4th month for follow-up. Method of measurement: Using the Patient Health Questionnaire (PHQ-9).;The score of death distress in the Death And Dying Distress Scale (DADDS). Timepoint: Before starting the intervention, the third month for evaluation and the 4th month for follow-up. Method of measurement: Using Death And Dying Distress Scale (DADDS).;The score of post-traumatic stress symptoms in Posttraumatic Stress Disorder Checklist (PCL-5). Timepoint: Before starting the intervention, the third month for evaluation and the 4th month for follow-up. Method of measurement: Using Posttraumatic Stress Disorder Checklist (PCL-5).;The quality of life score in the quality-of-life scale of patients with advanced cancer (QUAL-EC). Timepoint: Before starting the intervention, the third month for evaluation and the 4th month for follow-up. Method of measurement: Using Quality of life scale of patients with advanced cancer (QUAL-EC).;The memory score in the Prospective and Retrospective Memory Questionnaire (PRMQ). Timepoint: Before starting the intervention, the third month for evaluation and the 4th month for follow-up. Method of measurement: Using Prospective and Retrospective Memory Questionnaire (PRMQ).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSanaz Nabipour

The University of Kharazmi

nabipour.sanaz@gmail.com+98 21 2220 8653

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026