e-Motion : Promoting Emotion Regulation in Chronic Cancer

Université Libre de Bruxelles

Status: Enrolling

Conditions: Myeloma Multiple; Metastatic Cancers

Treatments: Behavioral: Guided Self-Help intervention; Behavioral: Group and Guided Self-Help intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07236021

PO20250132

Details and patient eligibility

About

The present study aimed to pilot evaluate two interventions: a Guided Self-Help Intervention alone, and a combined Group and Guided Self-Help Intervention, designed to support individuals living with chronic cancer and recently diagnosed. The primary aim of this pilot study is to assess the feasibility, acceptability and tolerability of the interventions. The secondary aim of the pilot study is to assess the interventions preliminary efficacy and differences on psychological symptoms.

Full description

The investigators aim to conduct a pilot study to assess feasibility, acceptability and tolerability of two interventions on 30 chronic cancer patients: a Guided Self-Help Intervention and a combined Group and Guided Self-Help Intervention. Both interventions will rely on emotion regulation component, with CBT, hypnosis, and positive psychology techniques.

The first 15 patients that will be recruited will be allocated to the Guided Self-Help Intervention (Arm 1). The recruitment of the 15 other patients will start after the last assessment of the last patient included in the first arm. These 15 other patients will be allocated by group of 5 to the combined Group and Guided Self-Help Intervention (Arm 2). Each participants will be assessed before intervention (T1), during intervention (Ecological weekly assessment, week 1 to week 12) and after the intervention (T2, 15 weeks after T1). T1 and T2 assessments will include self-reported questionnaires about psychological symptoms and a 7-day ecological momentary assessment (EMA) on emotions. In T2, a semi-structured interview will be performed for each participant to collect qualitative information on the tolerability and acceptability of the interventions. Participants will also complete a satisfaction questionnaire.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having received a diagnosis of chronic cancer (metastatic breast cancer, metastatic melanoma, metastatic colorectal, metastatic ovarian, metastatic uterine, metastatic endometrial, metastatic prostate, metastatic bladder, metastatic kidney or metastatic testicular cancer, symptomatic multiple myeloma, metastatic non-small cell lung, metastatic mesothelioma or metastatic thymoma) in the past 12 months,
• Having completed at least one active treatment session (e.g., chemotherapy, surgery, radiotherapy, immunotherapy, target therapy).

Exclusion criteria

• Having less than one year of life expectancy
• Having more than one treatment line (for triple negative breast cancer, melanoma, gynecological cancer, colorectal cancer, bladder cancer, kidney cancer, non-small cell lung, mesothelioma and thymoma) or two treatment lines (for other breast cancers and testicular cancer) or three treatment lines (for prostate cancer and multiple myeloma),
• Having a diagnosis of oligometastatic cancer,
• Age < 18 years,
• Non-fluency in French,
• Inability to follow the online intervention,
• Severe cognitive impairment, and severe and/or acute psychiatric disorder.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Guided Self-Help intervention arm

Active Comparator group

Description:

Guided self-help emotion regulation intervention for patient with chronic and incurable cancer.

Treatment:

Behavioral: Guided Self-Help intervention

Group and Guided Self-Help intervention arm

Experimental group

Description:

Group and guided self-help emotion regulation intervention for patient with chronic and incurable cancer.

Treatment:

Behavioral: Group and Guided Self-Help intervention