学位論文要旨



No 128310
著者(漢字) レデスマ ダイアン アティ二 アレマンザ
著者(英字) LEDESMA DIANNE ATHENE ALEMANZA
著者(カナ) レデスマ ダイアン アティニ アレマンザ
標題(和) フィリピン人乳がん患者を対象とする6週間のグループ心理療法に関するランダム化比較試験
標題(洋) A randomized controlled study of a 6-week group psychoeducational program for Philippine breast cancer patients
報告番号 128310
報告番号 甲28310
学位授与日 2012.03.22
学位種別 課程博士
学位種類 博士(保健学)
学位記番号 博医第3969号
研究科 医学系研究科
専攻 健康科学・看護学専攻
論文審査委員 主査: 東京大学 准教授 島津,明人
 東京大学 講師 永田,智子
 東京大学 教授 神馬,征峰
 東京大学 講師 ポウデル,クリシュナ チャンドラ
 東京大学 教授 小山,博史
内容要旨 要旨を表示する

Introduction. Breast cancer is the most common form of cancer and the leading cause of death due to cancer among Philippine women, with an estimated 14,043 new patients diagnosed in 2005 (25% of all cancer cases) and 6,357 deaths. The age-standardized incidence rate for breast cancer among women in the Philippines is 55.2 per 100,000 (1998-2002). In terms of cancer stage, the average cancer incidences of a representative sample in the Manila area (the country's capital) and its surrounding provinces from 1993-2002 were: Stage I=5%, IIA=20%, IIB= 18%, IIIA=9%, IIIB=10%, IV=11%, Unknown=28%.The median length of survival among Philippine women with breast cancer is 60 months, with a 5-year survival rate of 50.10%.

The deleterious effects of cancer on an individual can be significant. These effects include depression, anxiety, fatigue, mood disturbances (such as tension, anger, and confusion), and other psychosocial issues that could result in poorer quality of life during the survival period. Furthermore, individuals affected by cancer have to face a reduced ability to control their life, an increased dependency on others, and disequilibrium in their familial, professional and social life. Hence, there is a need to address and support patients in their psychosocial struggles with cancer, beginning from diagnosis to treatment and later survivorship.

Group psychotherapy is one of the psychosocial interventions available to cancer patients. It has been widely used as a therapeutic tool to address the psychosocial needs that arise from the diagnosis and treatment of cancer. It has also been known to provide significant improvement in mood, quality of life, and coping skills among cancer patients. At the same time, it is also seen as a more time and cost-effective form of psychosocial therapy than individual therapy. Group psychotherapy programs for cancer patients in Asia are few. This study thus set out to determine the applicability and efficacy of a 6-week group psycho-educational program for Philippine breast cancer patients in terms of improvement in psychosocial aspects.

Methodology: This study was conducted at the University of Santo Tomas Hospital Benavides Cancer Institute (BCI) in Manila, Philippines. The BCI is one of the few cancer institutions in the Philippines, and it offers multi-disciplinary professional medical service for cancer patients. The applicability of the 6-week group psychoeducational program for Philippine breast cancer patients was first pre-tested in a pilot study. The pilot study was conducted from May to June, 2009, wherein 10 patients were invited to participate in a group psychotherapy program. The Fawzy program has three sections, each lasting 30 minutes or so: Health Education (wherein experts were invited to give medical and psychological information and daily life topics in relation to cancer), Coping Skills (wherein patients were taught to identify positive and negative coping skills and apply such skills to their daily life), and Relaxation Training and Stress Management (wherein patients were trained in Progressive Muscle Relaxation). The group met for two hours each week for six (6) weeks. Groups were facilitated by a Clinical Psychologist assisted by a medical doctor and a palliative care nurse.

The randomized controlled trial was done to determine whether there is a significant difference in the psychosocial outcomes of patients who undergo the program compared to those who do not. Forty (40) patients who satisfied the Inclusion Criteria were randomized into an Intervention Group (20) and a Control Group (20). The inclusion criteria were: 1) Age between 18-65 years old, 2) Female breast cancer out-patients between stages I-III of primary breast cancer, 3) Between 4-24 months post-surgery, 4) Not under active chemotherapy or radiotherapy treatment during the observation period from baseline to the 3-month follow-up, 4) Physically able to come to the intervention site, 5) Can read and write in the English language (English is one of the two official languages of the Philippines), and 6) Have given written informed consent. The Intervention Group underwent therapy one week after baseline measures were taken in an Orientation Session (wherein the research was explained to all the recruited patients), while the Control Group was asked to wait for 3 months until they would undergo the same program.

Psychosocial measurement scales used to assess the effectiveness of the therapy were: Brief Fatigue Index (BFI), Hospital Anxiety and Depression Scale (HADS), Profile of Mood States (POMS), EORTC Quality of Life Scale QLQC30 and BR23 Breast Module, Medical Outcomes Survey Social Support Scale (MOS), and Brief COPE. The primary outcome variable was the Total Mood Disturbance score on the POMS scale, as this is the most consistently reported outcome in other studies using this particular therapy program.

The measurements were given at three timepoints: Baseline (T1), Immediately post-therapy (T2), and at 3-month Follow-up (T3). Two-way ANOVA with repeated measures was used for analysis. The level of significance was set at P<.05.The main result sought for was the time by group interaction, since this would signify if the 6-week group psychotherapy program has any effect on those who undergo it compared to those who do not. Additional post-hoc analyses (pairwise comparisons) were done for significant variables to assess how and where the differences between groups emerged.

Results: The pilot study showed that with minor modification of the content, the 6-week group psychoeducational program by Fawzy is adaptable for Philippine breast cancer patients. Participants expressed satisfaction with the program and suggested topics that could be included. Discussions between the facilitator and researcher were also taken into consideration in modifying the program.

In the randomized study, results showed that the Intervention Group had lower Total Mood Disturbance (POMS) compared to the Control Group, F(2,52)=4.401, MSE=3.314, p=.02. Post-hoc comparisons showed that the Control Group had increasing mood disturbance from T1 to T3, implying that greater mood disturbance might occur in breast cancer patients who do not undergo therapy. The Intervention Group also showed a better Global Health Status (EORTC Quality of Life Scale), F(2,54)=3.440, MSE=120, p=.05. This implied that patients who undergo this group psychotherapy program might draw benefit from the skills and information learned during the program to conduct a better quality of life. Furthermore, positive coping skills were used more frequently by the Intervention Group compared to the Control Group. In the Brief COPE scale, the Use of Instrumental Support subscale [F(2,54)=5.528, MSE=.328, p=.01] and the Planning subscale [F(2,54)=3.843, MSE=.284, p=.03] were utilized more by the Intervention Group than the Control Group, implying better willingness to adjust to problems. On the other hand, the Control Group used more of the negative coping skill, Self-blame [F(2, 54)=3.118, MSE=.237, p=.05] compared to the Intervention Group, implying worse adjustment to the problem at hand. The results showed the positive effects of the group psychoeducational program on Philippine breast cancer patients in terms of increasing positive attributes (positive coping skills, quality of life), while decreasing negative consequences (mood disturbance, negative coping skills) associated with cancer.

Conclusions and Research Implications: A 6-week group psychoeducational program originated by Fawzy et al. shows promise as an effective tool to address the unmet psychosocial needs of Filipino breast cancer patients. Although developed in the West, this program may be acceptable to and appreciated by Asian patients whose cultural values and background may differ from western patients. Most group psychotherapy program models originate from the west and cater to western patients. The applicability of such a program towards Asian patients is of interest because Asian patients also demonstrate the need to have their psychosocial issues in cancer addressed effectively. Many Philippine breast cancer patients have access to regular medical care but have an unmet need for psychosocial care in dealing with cancer issues. That a 6-week group psycho-educational program may be effective for Philippine patients implies a new window of access open to them in helping them cope with the effects of experiencing breast cancer and serves as a cost-effective means to provide holistic care in a third world country. However, since psychosocial care for cancer is not prioritized in the Philippines, it remains a challenge to convince hospitals and cancer care centers to provide such in the future.

審査要旨 要旨を表示する

本研究はフィリピンにおける乳がん患者を対象にして米国で始まる6週間グループ心理療法は患者の心理的健康度、疲労、Quality of Life、主観的身体症状への効果を明らかにするためパイロットスタディとランダム化比較試験を実施し6週間グループ心理療法への参加によって上記のような心身への影響に有意な差がみられるかどうかを検証し、下記の結果を得ている。

1. 本研究は、まずパイロットスタディによって米国で始まる6週間のグループ心理療法プログラムはフィリピンの乳がん患者に適するかどうかを検証した。フィリピン・マニラ市の三次がん病院(University of Santo Tomas Hospital:以下USTH) に通う外来乳がん患者のうち、後述する参加基準を満たした10名が2009年5-6月にグループ心理療法プログラムを受けた。この10名の患者のグループ心理療法プログラムに対する印象と意見、そしてプログラムのファシリテタと研究者のディスカッションをもとにして、グループ心理療法プログラムの一部をフィリピン患者に適したものにするため変更した。6週間グループ心理療法プログラムはフィリピンの乳がん患者に適することを示した。

2. USTHにて2010年6月―2011年10月にランダム化比較試験をした。対象者40名を2グループにわけた(介入群20名、対照群20名)。介入群は先に6週間グループ心理療法プログラムを受けた。対照群は3か月後に同じグループ心理療法プログラムを受けた。プログラム開始前(T1)、終了直後(T2)及び3か月後(T3) に対象者はPOMS (Profile of Mood States) 、EORTC-QLQ-C30、EORTCQLQ-BR23、HADS(Hospital Anxiety and Depression Scale), Brief COPE、MOS (Medical Outcomes Survey) Social Support Scale, Brief Fatigue Indexに記入した。

結果は40名のうち7名はドラップアウトし(介入群2名、対照群5名)、 2名はがんの再発があった(介入群1名、対照群1名)。更に 対照群の2名のT2データは記入されていなかった。参加した40名の患者の平均年齢は47歳(標準偏差±8.35)、62.5%は既婚、62.5%は大学卒であった。乳がんの段階は57.5%がStage 2, 35%がStage 3であった。またこの研究に参加した時点で乳がんの診断と治療を開始してから約1年経過していた。治療として全員の患者が手術を受けていた。90%は化学治療も受け、更に72.5%は放射線治療も受けた。また 58%は維持療法としてホルモン治療を受けていた。

3. 分析した患者は29名(介入群17名、対照群12名)であった。POMSでは介入群は対照群より低いTotal Mood Disturbanceを示した[F(2,52)=4.401, MSE=3.314, p=.02]。EORTC-QLQ-C30では介入群は対照群より高いQuality of Lifeを示した[F(2,54)=3.440, MSE=120, p=.05]. Brief COPE (コ―ピングスキル尺度)では介入群はポジティブスキルの中でInstrumental Support [F(2,54)=5.528, MSE=.328, p=.01]とPlanning [F(2,54)=3.843, MSE=.284, p=.03]を対照群より使用頻度が高かった。一方でネガティブスキルのSelf-blame [F(2, 54)=3.118, MSE=.237, p=.05]は対照群の使用頻度が高かった。

本論文は6週間のグループ心理療法プログラムがフィリピ乳がん患者に対して心身の健康を向上させることを示した。これまでフィリピンではこのような心理療法プログラムはなく、フィリピン人のがん患者を対象として心理的効果を検討した研究は少なかった。本研究は6週間グループ心理療法プログラムがTotal Mood Disturbanceを低下させQuality of Lifeとポジティブコ―ピングスキルを高めることを明らかにした。以上より、本研究がフィリピン人乳がん患者の心身の健康を向上させるための効果的なサービス提供に貢献することが期待でき、学位の授与に値するものと考えられる。

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