Rectal Cancer, Rectum
Conditions
Keywords
Rectum, Quality of Life, Sexual Health, 08-073
Brief summary
We know that treatment for rectal, colorectal or anal cancer can impact sexual function. This study aims to learn: * How the treatment affects emotional and social well-being. * How a new sexual health educational program affects you. Cancer patients seek education for lots of reasons. It often helps them cope because they can express their feelings with a trained professional. This study is open to individuals who have been treated for rectal, colorectal or anal cancer. It involves a new type of sexual health counseling program. It will teach participants skills that they can use to improve their sex lives. These skills may also improve physical and emotional well-being. We will compare the new type of sexual health program with the standard care patients receive after treatment for rectal, colorectal or anal cancer.
Detailed description
This is a two year randomized clinical trial examining the feasibility, tolerability, acceptability (including adherence) and efficacy of an intervention designed to improve sexual functioning of survivors of rectal cancer. We have completed enrollment of female patients and are currently collecting follow up data. Recruitment for male patients is ongoing. Male participants will now be randomized in a 3:1 ratio to either the intervention condition (n = 40) or the control condition (n = 40).
Interventions
BEHAVIORALquestionnaires
Participants randomized to the Usual Care arm will receive standard care . For women, this is defined as the care that participants who are not in the intervention receive; we will ask these participants what psychosocial care they are receiving to track usual care. For men, "usual care" will consist of a standardized referral to the men's Sexual Medicine Program at MSKCC and written information in the form of the American Cancer Society (ACS) booklet on Sexuality after Cancer. Individuals randomized to Usual Care will not receive any additional counseling sessions from the study interventionists until they are done with the follow up interviews and then it will be offered to them. Follow up questionnaires will assess all study participants at 4 and 8 months after baseline.
BEHAVIORALCSI-SH- Cancer Survivorship Intervention
This involves four 1-hour individual sessions with three additional telephone booster/review sessions provided in between the four sessions. Sessions can be completed in person or conducted over the phone. Although every effort will be made to complete the booster session in between counseling sessions, if the patient is unavailable to complete the booster calls they may be skipped. Sessions one and two will focus on rehabilitation techniques and tools will be provided and discussed with participants during these first two sessions.
Sponsors
Memorial Sloan Kettering Cancer Center
Albert Einstein College of Medicine
Icahn School of Medicine at Mount Sinai
M.D. Anderson Cancer Center
National Institutes of Health (NIH)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least six months post radiation and/or surgery for stage I-III rectal adenocarcinoma or rectosigmoid for cancer with an anastomosis at 15 cm or below and completed treatment * At least six months post radiation and/or chemotherapy for anal cancer. * Have no evidence of disease or recurrence * For women indicate Indicate moderate satisfaction or below on their overall sexual life (a score of "4" or lower on the question "Over the past 4 weeks, how satisfied have you been with your overall sexual life?" * For men indicate, and a score of "3" or lower on the question "How would you rate your confidence that you could get and keep an erection" for men) and a score of "2" or higher on the question "How much does this problem bother you? * In the judgment of the consenting professional interventionists, able to communicate in English well enough to work with English speaking and complete the study assessments. * Age 21 years or older.
Exclusion criteria
* Significant cognitive or psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in a psychotherapeutic intervention. * Are actively participating in protocol 06-151 * Participated in focus group or qualitative interview.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Female Sexual Functioning Index (FSFI) Total Score for Women From Baseline to Follow-up 1 | 4 months post-baseline (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 | 8 months post-baseline (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 | 4 months post-baseline (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 | 8 months post-baseline (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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Impact of Events Scale-Revised (IES-R) Total Score for Women and Men From Baseline to Follow up 1 | 4 months post-baseline (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 | 8 months post-baseline (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 | 4 months post-baseline (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 | 8 months post-baseline (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 | 4 months post-baseline (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 | 8 months post-baseline (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 | 4 months post-baseline (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 | 8 months post-baseline (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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristian Nelson, PhD
Memorial Sloan Kettering Cancer Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.40 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 134 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 128 Participants |
| Region of Enrollment United States | 149 Participants |
| Sex: Female, Male Female | 72 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 69 | 11 / 80 |
| other Total, other adverse events | 0 / 69 | 0 / 80 |
| serious Total, serious adverse events | 0 / 69 | 0 / 80 |
Outcome results
None listed