직장암 환자의 성 건강

1

일반 진료(UC)는 환자가 받는 표준 진료입니다.

행동: 설문지

유쥬얼 케어 부문에 무작위 배정된 참가자는 표준 케어를 받게 됩니다. 여성의 경우 이는 중재에 참여하지 않는 참가자가 받는 치료로 정의됩니다. 우리는 이 참가자들에게 평소 치료를 추적하기 위해 어떤 심리사회적 치료를 받고 있는지 물어볼 것입니다. 남성의 경우 "일반적인 치료"는 MSKCC의 남성 성의학 프로그램에 대한 표준화된 의뢰와 암 후의 성에 관한 미국 암 학회(ACS) 소책자 형식의 서면 정보로 구성됩니다. Usual Care에 무작위 배정된 개인은 후속 인터뷰가 완료되고 제공될 때까지 연구 중재자로부터 추가 상담 세션을 받지 않습니다. 후속 설문지는 기준선 이후 4개월 및 8개월에 모든 연구 참가자를 평가합니다.

2

Cancer Survivorship Intervention-Sexual Health(CSI-SH) 및 일반적인 치료(미국)

행동: CSI-SH- 암 생존자 개입

여기에는 4개의 세션 사이에 제공되는 3개의 추가 전화 부스터/리뷰 세션과 함께 4개의 1시간 개별 세션이 포함됩니다. 세션은 직접 방문하거나 전화로 진행할 수 있습니다. 상담 세션 사이에 부스터 세션을 완료하기 위해 최선을 다하겠지만 환자가 부스터 호출을 완료할 수 없는 경우 건너뛸 수 있습니다. 세션 1과 2는 재활 기술과 도구에 초점을 맞출 것이며 처음 두 세션 동안 참가자들과 논의할 것입니다.

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).