直腸がん患者の性的健康

1

患者が受ける標準的なケアである通常のケア（UC）

行動：アンケート

通常のケア群に無作為に割り付けられた参加者は、標準的なケアを受けます。 女性の場合、これは介入に参加していない参加者が受けるケアとして定義されます。通常のケアを追跡するために、これらの参加者が受けている心理社会的ケアを尋ねます。 男性の場合、「通常のケア」は、MSKCC の男性用性医学プログラムへの標準化された紹介と、がん後のセクシュアリティに関する米国がん協会 (ACS) の小冊子の形で書かれた情報で構成されます。 通常のケアに無作為に割り付けられた個人は、フォローアップのインタビューが完了するまで、研究介入者から追加のカウンセリングセッションを受けません。その後、インタビューが提供されます。 フォローアップアンケートは、ベースラインから4か月後および8か月後にすべての研究参加者を評価します。

2

Cancer Survivorship Intervention-Sexual Health (CSI-SH)plus 通常のケア (米国)

行動：CSI-SH-がんサバイバーシップ介入

これには、1 時間の個人セッションが 4 回と、4 つのセッションの間に 3 つの追加の電話ブースター/レビュー セッションが含まれます。 セッションは対面で行うことも、電話で行うこともできます。 カウンセリングセッションの間にブースターセッションを完了するためにあらゆる努力が払われますが、患者がブースターコールを完了することができない場合、それらはスキップされることがあります. セッション 1 と 2 では、リハビリテーションのテクニックとツールに焦点を当て、これらの最初の 2 つのセッションで参加者と話し合います。

Change in Female Sexual Functioning Index (FSFI) Total Score for Women From Baseline to Follow-up 1

The FSFI (Female Sexual Functioning Index) is a brief, self-report measure of female sexual function. The 19 items use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual function. The total score for the Female Sexual Function Index (FSFI) ranges from a minimum of 2.0 to a maximum of 36.0

Change in Female Sexual Functioning Index (FSFI) Total Score for Women From Baseline to Follow-up 2

The FSFI is a brief, self-report measure of female sexual function. The 19 items use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual function. The total score for the Female Sexual Function Index (FSFI) ranges from a minimum of 2.0 to a maximum of 36.0

Changes International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 1

The IIEF is a 15-item questionnaire designed to assess erectile functioning. Scores of 0 to 5 are awarded to each of the 15 questions. The five domains assessed include Erectile Function (Max score 30), Orgasmic Function (Max score 10), Sexual Desire (Max score 10), Intercourse Satisfaction (Max score 15) and Overall Satisfaction (Max score 10). Overall Scoring: 1-10: Severe Erectile Dysfunction, 11-16: Moderate dysfunction,17-21: Mild to moderate dysfunction, 22-25: Mild dysfunction, 26-30: No dysfunction. Higher scores indicate better sexual function/better outcome.

Changes in International Index of Erectile Function (IIEF) for Men From Baseline to Follow up 2

The IIEF is a 15-item questionnaire designed to assess erectile functioning. Scores of 0 to 5 are awarded to each of the 15 questions. The five domains assessed include Erectile Function (Max score 30), Orgasmic Function (Max score 10), Sexual Desire (Max score 10), Intercourse Satisfaction (Max score 15) and Overall Satisfaction (Max score 10). Overall Scoring: 1-10: Severe Erectile Dysfunction, 11-16: Moderate dysfunction,17-21: Mild to moderate dysfunction, 22-25: Mild dysfunction, 26-30: No dysfunction. Higher scores indicate better sexual function/better outcome.

Change in Impact of Events Scale-Revised (IES-R) Total Score for Women and Men From Baseline to Follow up 1

The IES-R is a self-report measure designed to assess current subjective distress for any specific life event. Respondents rate each item in the IES-R on a scale of 0 (not at all), 1 (a little bit), 2 (moderately), 3 (quite a bit) and 4 (extremely) according to the past 7 days with regard to cancer and its treatment. the total score for the IES-R assessment can range from 0-88. In general, the higher the score, the more severely a person's life is disrupted by a traumatic event.

Change in Impact of Events Scale-Revised (IES-R) Total Score for Women and Men From Baseline to Follow up 2

The IES-R is a self-report measure designed to assess current subjective distress for any specific life event. Respondents rate each item in the IES-R on a scale of 0 (not at all), 1 (a little bit), 2 (moderately), 3 (quite a bit) and 4 (extremely) according to the past 7 days with regard to cancer and its treatment. the total score for the IES-R assessment can range from 0-88. In general, the higher the score, the more severely a person's life is disrupted by a traumatic event.

Changes in Depression and Anxiety Symptom Dimension Scores of Brief Symptom Inventory (BSI) for Women From Baseline to Follow up 1

The BSI (Brief Symptom Inventory) consists of 53 items. Participants rate the extent to which they have been bothered (0 ="not at all" to 4="extremely") in the past week by various symptoms. Higher scores indicate greater emotional distress. The BSI uses a 5-point Likert scale (0 = Not at all, 4 = Extremely), with rankings characterizing the intensity of distress during the past seven days. Scores are calculated as follows: Sum the item scores and divide by the number of items to obtain the mean score. Higher scores indicate greater emotional distress.

Changes in Depression and Anxiety Symptom Dimension Scores of Brief Symptom Inventory (BSI) for Women From Baseline to Follow up 2

The BSI (Brief Symptom Inventory) consists of 53 items. Participants rate the extent to which they have been bothered (0 ="not at all" to 4="extremely") in the past week by various symptoms. Higher scores indicate greater emotional distress. The BSI uses a 5-point Likert scale (0 = Not at all, 4 = Extremely), with rankings characterizing the intensity of distress during the past seven days. Scores are calculated as follows: Sum the item scores and divide by the number of items to obtain the mean score. Higher scores indicate greater emotional distress.

Change in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Total Score for Women From Baseline to Follow up 1

EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire ) is a well-validated instrument that assesses health-related quality of life in cancer patients. It is composed of 30-items, which factor into scales that evaluate physical functioning and role functioning, as well as emotional, social, and cognitive functioning and global QOL. Three symptom scales measure fatigue, pain, and emesis, while six single items assess financial impact, dyspnea, sleep disturbance, appetite, diarrhea, and constipation. The EORTC QLQ-C30 Summary Score is calculated from the mean of 13 of the 15 QLQ-C30 scales (the Global Quality of Life scale and the Financial Impact scale are not included). All of the scales and measures range in score from 0 to 100. A high scale score represents a higher response level/better outcome.

Change in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Total Score for Women From Baseline to Follow up 2

EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire ) is a well-validated instrument that assesses health-related quality of life in cancer patients. It is composed of 30-items, which factor into scales that evaluate physical functioning and role functioning, as well as emotional, social, and cognitive functioning and global QOL. Three symptom scales measure fatigue, pain, and emesis, while six single items assess financial impact, dyspnea, sleep disturbance, appetite, diarrhea, and constipation. The EORTC QLQ-C30 Summary Score is calculated from the mean of 13 of the 15 QLQ-C30 scales (the Global Quality of Life scale and the Financial Impact scale are not included). All of the scales and measures range in score from 0 to 100. A high scale score represents a higher response level/better outcome.

Change in Male-specific Variables (SEAR and Sexual Bother Subscale of the PHR-QOL) for Men From Baseline to Follow up 1

The Sexual Self-Esteem and Relationship Questionnaire (SEAR) is a 14-item measure that assesses sexual relationship satisfaction, sexual self-esteem, and overall relationship satisfaction. This measure was developed for use in men with ED. The items are scored on a 5-point Likert scale with higher scores indicating higher sexual satisfaction and sexual self-esteem. Higher scores indicated a more favorable response (0 = least favorable, 100 = most favorable). The Sexual Bother (SB) subscale of the Prostate-Health Related QOL (PHR-QOL) questionnaire is a 4-question scale that assesses men on a 5-point Likert scale (0-20). The four questions assess how sexual function has impacted close relationships, how big a problem it has been, if the patients have felt ashamed or embarrassed by their sexual function, and if it has impacted their ability to enjoy life. Higher scores indicate better outcomes (better functioning; less bother).

Change in Male-specific Variables (SEAR and Sexual Bother Subscale of the PHR-QOL) for Men From Baseline to Follow up 2

The Sexual Self-Esteem and Relationship Questionnaire (SEAR) is a 14-item measure that assesses sexual relationship satisfaction, sexual self-esteem, and overall relationship satisfaction. This measure was developed for use in men with ED. The items are scored on a 5-point Likert scale with higher scores indicating higher sexual satisfaction and sexual self-esteem. Higher scores indicated a more favorable response (0 = least favorable, 100 = most favorable). The Sexual Bother (SB) subscale of the Prostate-Health Related QOL (PHR-QOL) questionnaire is a 4-question scale that assesses men on a 5-point Likert scale (0-20). The four questions assess how sexual function has impacted close relationships, how big a problem it has been, if the patients have felt ashamed or embarrassed by their sexual function, and if it has impacted their ability to enjoy life. Higher scores indicate better outcomes (better functioning; less bother).