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Preliminary application study for CALM therapy in Chinese advanced cancer patients

Preliminary application study for CALM therapy in Chinese advanced cancer patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023129
Enrollment
Unknown
Registered
2019-05-13
Start date
2019-05-01
Completion date
Unknown
Last updated
2019-05-20

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

Conditions

Advanced cancer

Interventions

Intervention group:CALM therapy
control group:usual care

Sponsors

Peking University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Clinicians involved in this study will be [insert profession] who are: (i) involved in the care of patients with advanced or metastatic cancer; (ii) able to deliver psychotherapy according to the local legislation/organizational policies that regulate their profession; (iii) =18 years of age; (iv) able to provide informed consent; (v) fluent in English (or other language(s) in which training and supervision will be offered);; (vi) willing/able to engage with training in the CALM therapy and attend in-person or online supervision meetings (based on feasibility). Clinicians will be approached by the research team from PM to participate in the larger global study. Patient Inclusion criteria: all patients involved in the study will: (i) be =18 years of age; (ii) be fluent in the main language spoken in the city where their centre is located; (iii) be able to provide informed consent; and (iv) have received a diagnosis of advanced or metastatic solid-tumour cancer (e.g. stage III or IV lung or ovarian cancer; any stage of pancreatic cancer (due to the aggressiveness of this disease); other stage IV gastrointestinal, gynecological, breast, genitourinary, sarcoma, melanoma or endocrine cancer; or unresectable cholangiocarcinoma, liver, ampullary or peri-ampullary cancer). Family caregiverInclusion criteria: family caregivers of patients involved in the study will be invited to participate in one or more CALM sessions (which may be audio- or video-recorded, for which consent of both patient and caregiver are required to allow use of the recordings for research and/or educational purposes). [OPTIONAL] Additionally, caregivers will be invited to complete a qualitative interview. For this qualitative sub-study, caregivers will be: (i) =18 years of age; (ii) fluent in the main language spoken in the city where their centre is located; and (iii) able to provide informed consent.

Exclusion criteria

Exclusion criteria: Patient Exclusion criteria for patient-participants are: (i) major communication difficulties; (ii) inability to commit to the required 3-6 psychotherapy sessions (e.g., too ill to participate, lack of transportation, insufficient motivation to participate, etc.); and (iii) cognitive impairment as indicated by the clinical team or in the patients chart. Family caregiver Exclusion criteria: (i) major communication difficulties; and (ii) cognitive impairment as indicated by the clinical team, or in the patients chart, or at the discretion of the research team (if cognitive impairment interferes with providing informed consent).

Design outcomes

Primary

MeasureTime frame
Patient Health Questionnaire-9;

Secondary

MeasureTime frame
Distress thermometer;Death and Dying Distress Scale;Functional Assessment of Chronic Illness Therapy–Spiritual Well-Being Scale;Brief Experiences in Close Relationships scale;Quality at the End of Life in Cancer;City of Hope-QOL Scale Family Version;subjective experience about CALM therapy;

Countries

China

Contacts

Public ContactTang Lili

Department of Psycho-oncologyPeking, Peking University Cancer Hospital

tanglili_cpos@126.com+86 010-88196648

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026