Addressing the effectiveness of an intervention to improve mental adjustment to breast cancer

Addressing the effectiveness of an intervention to improve mental adjustment to breast cancer: A longitudinal and experimental study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN23579632

Enrollment

120

Registered

2023-10-27

Start date

2019-06-01

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Quality of life in female patients with breast cancer Cancer

Interventions

The present study is a randomised controlled trial. Adding to regular clinical services is a psychosocial intervention to facilitate mental adjustment to breast cancer and its consequences versus no t

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 2. Aged 18 years old and over 2. Diagnostic of primary breast cancer tumor that requires a surgery intervention

Exclusion criteria

Exclusion criteria: Having a psychiatric disorder or under any psychological treatment at the moment of being enrolled

Design outcomes

Primary

Measure	Time frame
Psychological well-being measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 3, 6 and 12 months after surgery	—

Secondary

Measure	Time frame
1. Health-related quality of life measured using the Health-related quality of life measure EORTC-QLQ-C30 at baseline, 3 and 12 months after surgery. Psychiatric drug use (i.e., pain killers, antidepressants, and anxiolytics) measured using self-reported measures of frequency of use (from 0 = never to 4 = almost every day) at 3, 6 and 12 months after surgery	—

Countries

Spain

Contacts

Public ContactJose M Leon-Perez

leonperez@us.es+34 954557707

Outcome results

None listed

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