Adaptation and Feasibility of Managing Cancer and Living Meaningfully (CALM) Intervention for Patients with Advanced Cancer in Iran: Investigating Its Cognitive and Psychological Impacts
Adaptability and feasibility of Cancer Management and Meaningful Life (CALM) intervention for patients with advanced cancer in Iran and investigating its cognitive and psychological effects.
Design
A pretest-post-test clinical trial with the control group and follow-up. Phase 2-3 on 50 patients. Randomized using random sequence generation software.
Settings and conduct
In the first stage, the intervention will be performed on 3 to 5 eligible patients referred to the oncology services of Imam Khomeini Hospital in Tehran. Program deficiencies will be identified and improved based on patients' feedback and professors' comments. Then, 50 people will be selected, randomly divided, and received interventions. All participants will complete all questionnaires at baseline (T0), month 3 (T1), and month 4 (T2).
Participants/Inclusion and exclusion criteria
Eligible patients are greater than18 years; fluent in Persian; with a diagnosis of malignant solid tumor (UICC III or IV); average life expectancies between 12 and 18 months; and have a score greater than or equal to 10 on the PHQ-9 and/or greater than 5 on PCL-5 and/or greater than or equal to 20 on DADDS and/or lesser than 27 on MMSE.
Exclusion criteria are inability to commit to the required sessions; concomitant psychotherapy; severe sensorimotor disability or brain damage; reported suicidal ideas and/or criteria of psychosis.
Intervention groups
Patients are divided into two groups. A group receives CALM and the control group receives routine palliative treatment. CALM is a brief, manual supportive-expressive therapy, done individually or by inviting a family member depending on the patient's needs and wishes; three to six 45-60 minute sessions will be delivered twice monthly over three months.
Main outcome variables
Depression symptoms; post-traumatic stress symptoms; death stress; quality of life ;and retrospective-prospective memory
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230627058602N1
Registration date:2023-07-22, 1402/04/31
Registration timing:prospective
Last update:2023-07-22, 1402/04/31
Update count:0
Registration date
2023-07-22, 1402/04/31
Registrant information
Name
Sanaz Nabipour
Name of organization / entity
The University of Kharazmi
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 8653
Email address
nabipour.sanaz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Adaptation and Feasibility of Managing Cancer and Living Meaningfully (CALM) Intervention for Patients with Advanced Cancer in Iran: Investigating Its Cognitive and Psychological Impacts
Public title
Adaptation, feasibility, and investigation of CALM on cognitive and psychological problems of patients with advanced cancer
Purpose
Supportive
Inclusion/Exclusion 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:
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
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
We will use simple stratified randomization with 1:1 allocation between arms. Computerized randomization will be created, administered, and password protected by a researcher at Razi University independent of the research team. After obtaining written informed consent and completing the initial steps, the research assistant contacts the center via email to receive the subject and inform the patients about the therapist they will be seeing. No member of the research team will have access to the randomization list.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Imam Khomeini Hosp
Street address
Management of Research and Technology Affairs of the University, 6th Floor, Central Building of Tehran University of Medical Sciences, Intersection of Keshavarz Blvd and Qods Street, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-06-20, 1402/03/30
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.117
Health conditions studied
1
Description of health condition studied
Malignant 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 other stage IV gynecological cancer; and stage IV breast, genitourinary, gastrointestinal, melanoma, sarcoma, or endocrine cancers
ICD-10 code
C00-C80
ICD-10 code description
Malignant neoplasms, of specified sites, except of lymphoid, haematopoietic and related tissue
Primary outcomes
1
Description
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)
2
Description
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)
3
Description
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)
4
Description
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)
5
Description
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)
Secondary outcomes
empty
Intervention groups
1
Description
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 distress in patients with advanced cancer. It consists of three to six sessions, usually of 45 minutes, delivered across 3 to 6 months, and addresses 4 main domains: symptom control and communication with health care providers; 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 patient and caregiver needs by using supportive approaches, such as education and validation, and expressive approaches, including facilitation of reflection and creation of meaning. So the therapist facilitates exploration of four broad domains, while also attuning to and helping to regulate the patient’s emotional state. Control group: They are referred to the palliative clinic to receive common treatment. Their therapeutic approach is based on an integrative approach consisting of psycho-oncological counseling, provision of information, crisis intervention as well as supportive individual therapy. As for the intervention arm, patients randomized to the control arm will receive up to six, 50-min sessions delivered over 3 months.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Sanaz Nabipour
Street address
The intersection of Keshavarz Boulevard and Gharib Street
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6658 1542
Email
nabipour.sanaz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotuhi
Street address
No 605, 6th Floor, Central Organization of the University, Corner of Quds St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Kharazmi
Full name of responsible person
Sanaz Nabipour
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Psychology
Street address
First Flour, No. 307, Mojahedin Ave and Rahmanipour Ave Junc., Baharestan
City
Tehran
Province
Tehran
Postal code
1154917513
Phone
+98 21 2220 8653
Fax
Email
nabipour.sanaz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Kharazmi
Full name of responsible person
Alireza Moradi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 43, Shahid Muftah St.
City
Tehran
Province
Tehran
Postal code
۱۴۹۱۱۱۵۷۱۹
Phone
+98 21 8832 9220
Fax
Email
moradi90@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Kharazmi
Full name of responsible person
Sanaz Nabipour
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Psychology
Street address
First Flour, No. 307, Mojahedin Ave and Rahmanipour Ave Junc., Baharestan
City
Tehran
Province
Tehran
Postal code
1154917513
Phone
+98 21 2220 8653
Fax
Email
nabipour.sanaz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic information, excluding personally identifiable information, medical information, and primary outcome information, may be shared. Also, the information obtained from the analysis of tests and questionnaires and the result of the research will be available to those interested in the form of an article.
When the data will become available and for how long
The start of the access period will be after the publication of the results in the form of an article, and will be for a maximum period of one year.
To whom data/document is available
Researchers working in academic and scientific institutions can request to send data.
Under which criteria data/document could be used
The information contained in the data will be provided to the applicant for study purposes only.
From where data/document is obtainable
Applicants can send their application through the email below: nabipour.sanaz@gmail.com
What processes are involved for a request to access data/document
In case of request via email, they will be answered within 48 working hours.