Husain Nusrat, Kiran Tayyeba, Chaudhry Imran B, Sultan Sarwat, Dawood Saima, Lunat Farah, Nizami Asad, Shanahan Lisa, Qureshi Afshan, Un Nisa Zaib, Husain Mina, Shakoor Suleman, Alvi Mohsin H, Zadeh Zainab, Memon Rakhshi, Chaudhry Nasim
Division of Psychology and Mental Health, University of Manchester, Manchester, UK.
Manchester Global foundation, Manchester, UK.
SAGE Open Med. 2023 Jun 29;11:20503121231177549. doi: 10.1177/20503121231177549. eCollection 2023.
The diagnosis and treatment of breast cancer is associated with significant distress that has huge impact on survivors' quality of life. The objective of this study is to assess the effectiveness of an integrated intervention "Moving on After Breast Cancer (ABC) Plus culturally adapted Cognitive Behavior Therapy" (Moving on ABC Plus).
This is a randomized controlled trial that aims to recruit 354 breast cancer survivors from the inpatient and outpatient oncology departments in public and private hospitals in Karachi, Hyderabad, Lahore, Multan, and Rawalpindi in Pakistan. Patients scoring 10 or above on either the Patient Health Questionnaire-9 and/or the Generalized Anxiety Disorder scale (GAD-7) will be recruited. Baseline assessments will include Functional Assessment of Cancer Therapy-Breast; EuroQol-5D; Multidimensional Scale for Perceived Social Support; Intrusive Thoughts Scale; and Rosenberg Self-Esteem Scale. Participants randomized into intervention arm, Moving on ABC Plus, will receive 12 individual therapy sessions over 4 months. Follow-up will be completed at 4- and 6-month post-randomization, using all baseline instruments along with the Client Satisfaction Questionnaire (CSQ-8). We will also explore the participants', their family members', and the therapists' experiences of the trial and intervention.
We will be assessing the effectiveness of intervention in reducing depression and anxiety in breast cancer survivors as a primary outcome of the trial. The secondary outcomes will include effectiveness of intervention in terms of reduction in intrusive thoughts and improvement in health-related quality of life, self-esteem, and perceived social support.
The results of the study will inform the design of a future larger randomized control trial with long-term follow-up.
乳腺癌的诊断和治疗会给患者带来巨大痛苦，对幸存者的生活质量产生重大影响。本研究的目的是评估综合干预措施“乳腺癌康复前行（ABC）加文化适应认知行为疗法”（ABC加）的效果。
这是一项随机对照试验，旨在从巴基斯坦卡拉奇、海德拉巴德、拉合尔、木尔坦和拉瓦尔品第的公立和私立医院的肿瘤住院部和门诊部招募354名乳腺癌幸存者。在患者健康问卷-9和/或广泛性焦虑障碍量表（GAD-7）中得分10分及以上的患者将被招募。基线评估将包括癌症治疗功能评估-乳腺癌；欧洲五维健康量表；多维感知社会支持量表；侵入性思维量表；以及罗森伯格自尊量表。随机分配到干预组（ABC加）的参与者将在4个月内接受12次个体治疗。随访将在随机分组后的4个月和6个月完成，使用所有基线工具以及客户满意度问卷（CSQ-8）。我们还将探讨参与者、其家庭成员和治疗师对试验和干预的体验。
作为试验的主要结果，我们将评估干预措施在减轻乳腺癌幸存者抑郁和焦虑方面的效果。次要结果将包括干预措施在减少侵入性思维以及改善与健康相关的生活质量、自尊和感知社会支持方面的效果。
该研究结果将为未来更大规模的长期随访随机对照试验的设计提供参考。
