Psychosocial support for partners of patients with haemato-oncological disease - a group-based intervention to empower psychosocial health

Not Applicable

Completed

• Conditions: Haemato-oncological diseases; Cancer

• Registration Number: ISRCTN16085028
• Lead Sponsor: José Carreras Leukemia Foundation

Brief Summary

2019 Protocol article in https://doi.org/10.1186/s12885-019-6094-2 (added 10/04/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-20
• Study Completion: 2022-07-31
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1. Patients who are diagnosed with a confirmed haematological neoplasia: incidences up to one year after diagnose or relapse, ICD-10 diagnoses: C81-C96 and D46, which are: Hodgkin’s lymphoma, Non-Hodgkin’s lymphoma, multiple myeloma, myelodysplastic syndrome, acute or chronic leukaemia
2. Patients who have a partner
3. Patients and partners need to be aged between 18 and 70 years
4. Partners must be mentally and physically able to attend the program
5. Treatment modality and phase of illness is negligible for participation
6. Partners will be assigned to one of two study groups, given that PHQ-9 > 9 (depression) and GAD-7 > 9 (anxiety)

Exclusion Criteria

1. Severe psychiatric disorders
2. Profound cognitive and physical impairment
3. An age limitation of 70 years aimed to minimise possible age-related comorbidities or mobility limitations

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Depression measured using the PHQ-9 (Patient Health Questionnaire) at Screening, Baseline (prior to intervention), 3 months and 6 months later<br>2. Anxiety measured using the GAD-7 (Generalization Anxiety Disorder Scale) at Baseline (prior to intervention), 3 months and 6 months later

Secondary Outcome Measures

Name	Time	Method
Measured prior to intervention, 3 months and 6 months later:<br>1. Quality of life, measured using Health Survey 12 (SF-12)<br>2. Fatigue, measured using Brief Fatigue Inventory (BFI)<br>3. Dyadic coping, measured using Dyadic Coping Inventory (DCI)<br>4. Attachment in close relationship, measured using Experience in close Relationships-Revised (ECR-RD)<br>5. Locus of control, measured using Internal, Powerful Others, and Chance Scale (IPC)